FOR BIS USE ONLY

Doc No.: SM/IS14543 & IS13428/03

MANUAL

FOR

PACKAGED WATER

(Third Issue)

Date of Issue: March 2013

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 CONTENTS

Item Chapter Page No

0 Foreword 3
1 Introduction 4
2 Scope 5
3 Product Description 5-8
4 Grant of Licence 8-14
5 Operation of Certification 14-19
6 Guidelines for Assessment of Hygienic Conditions with 19-35
Explanatory Notes
7 Useful Tips for Inspecting Personnel & Guidelines for Reused 35-37
Containers
ANNEXES
1 Check List For Scrutiny of Application 38-39
2 Report of Preliminary Inspection 40-45
3 Verification Report By BIS IO 46-47
3A Factory Testing Report 48
3B Samples for Independent Testing 49
4 Check List For Good Hygiene (Applications) 50-54
5 Typical Manufacturing Process, Process Flow Chart,CIP Process 55-58
6 Check List for Red Form Processing 59-61
7 Report of Periodic Inspection 62-65
7A Assessment of Compliance to IS 13428/IS 14543 66-67
7B Details of Testing from OSL 68
8 Hygiene Check List (Licences) 69-70
9 List of Test Facilities
A Organoleptic and Physical Requirements 71-73
B Chemical Requirements 74-98
C -Toxic Substances 99-105
D -Microbiological Requirements 106-113
E -Bottle / Container Requirements 114
F -PE Flexible Pouch Requirements 115-116

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0. FOREWORD

0.1 BIS has published two Indian Standards on packaged water for drinking purpose, namely, IS
13428 for Packaged Natural Mineral Water (PNMW) and IS 14543 for Packaged Drinking Water
(Other Than Packaged Natural Mineral Water) (PDW). Both the products were brought under
mandatory BIS certification effective from 29 March 2001 through two gazette notifications issued
by Ministry of Health and Family Welfare, namely GSR No. 759 for Packaged Natural Mineral
Water (PNMW) and GSR No. 760 for Packaged Drinking Water (PDW) as amendments to
Prevention of Food Adulteration Rules. Presently, these products under mandatory BIS certification
are covered under FSSAI regulation.

0.2 In the early stages of certification of PDW, different situations were handled differently by
ROs/BOs. This had necessitated issuance of several guidelines for creating uniformity in
certification of PDW throughout the country. Further, a need was felt to compile all these guidelines
into a manual. Thus, the Manual for PDW was brought out in the year 2005.

0.3 Revision of the Manual has been taken up to suitably incorporate the changes that had taken
place since 2005 in the certification of PDW and also in the general policies of product certification.
A specific sub-section for guidelines related to PNMW such as for constancy of source water and
criteria for decision seasonal variations etc introduced.

0.4 Packaged Drinking Water (Other Than Packaged Natural Mineral Water) (PDW) Packaged
Natural Mineral Water (PNMW) are basically packaged water for drinking purpose. Therefore, title
of this MANUAL is “MANUAL FOR PACKAGED WATER”.

0.5 Salient changes in this version of the Manual are as follows:

 updation of the manual with respect to various amendments to IS 14543 and IS

13428 and guidelines issued from time to time;
 incorporation of guidelines under simplified procedure for GOL and inclusion;
 updation of the list of test equipment as per revised test methods wherever applicable;
 inclusion of the list of test equipment for Bottles/Containers and PE Flexible Pouch for
Packaged Water; and
 exclusion of the provision of verification by Chartered Engineer under the simplified
scheme for grant of licence.

This Manual is intended only for internal use by BIS officers and inspection personnel working on
behalf of BIS. However, others can draw benefit from the Manual to improve their activities related
to certification of PDW and PNMW.

Suggestions for any improvement in this Manual may be sent to CMD – 2.

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1 INTRODUCTION

1.1. The Standard IS 14543 provides sufficient freedom to the manufacturer to adopt any process
for converting raw water into packaged water for drinking purposes. Therefore, the required
manufacturing machinery for the purpose is neither specified in the respective Indian Standard nor
in this Manual. Illustrative examples have been given of typical manufacturing process with process
flow diagram, cleaning and disinfection (CIP) of plant and machinery, pipelines as well as of
containers in Annex 5.

1.2. However, there are restrictions with regard to processing of PNMW as specified in IS 13428,
such as the source water shall not be subjected to process steps, such as reverse osmosis,
demineralization or disinfection before packaging.

1.3. IS 13428 and 14543 prescribe a large number of requirements to be tested as per the methods
of tests given in the various cross-referred standards. Further, many requirements have options for
selection of test method to be followed. This has made the task of the inspecting official difficult
and time consuming for complete assessment of adequacy of the test facilities. This Manual
provides a ready reference for the inspecting official to check facilities for each of the requirements
against the method given under the relevant Indian Standard and the method chosen by the firm
(Annex 9).

1.4. All efforts have been made to incorporate details as per the latest versions of the standards.
However, as the standards are dynamic and subject to amendments and revisions, users are
encouraged to check the latest versions of the respective methods of test subsequent to issuance of
this issue of the Manual, before using the information contained herein.

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2. SCOPE

2.1 This Manual of Packaged Water provides guidelines for various aspects related to
certification of Packaged Natural Mineral Water and Packaged Drinking Water (Other Than
Packaged Natural Mineral Water) according to IS 13428 and IS 14543 respectively along with the
respective STIs. The provisions of these Indian Standards, STIs, as also the various guidelines issued
from time to time for certification of packaged water have been kept in view while preparing this
Manual.

2.2 Explanatory notes have been incorporated wherever necessary to take care of subjective
interpretations.

2.3 Specific proformas have been included for submission of reports of preliminary, periodic and
verification inspections so as to facilitate uniform reporting by all concerned, covering all essential
parameters required to be reported as per the relevant ISS, STI. Other proformas for checking plant,
process and personnel hygiene; processing of application; preparation of red form for grant of
licence; test equipment details etc have also been included.

2.4 In case of any deviation, the requirements of the Indian Standards and the corresponding STIs
shall prevail.

3. PRODUCT DESCRIPTION

3.1 Packaged Drinking Water

3.1.1 Packaged drinking water means water derived from surface water or underground water or
sea water which may be subjected to specified treatments, namely, decantation, filtration,
combination of filtrations, aeration, filtration with membrane filter, depth filter, cartridge filter,
activated carbon filtration, demineralization, remineralization, reverse osmosis and packed after
disinfecting the water to a level that shall not lead to any harmful contamination in the drinking
water by means of chemical agents or physical methods to reduce the number of microorganisms to a
level beyond scientifically accepted level for food safety or its suitability: Provided that sea water,
before being subjected to the above treatments, shall be subjected to desalination and related
processes. It shall be filled in sealed containers of various compositions, forms and capacities that is
suitable for direct consumption without further treatment.

3.1.2 The water used for production of drinking water is water derived from any source of surface
water or underground water or sea water received on regular basis. Supplies of such water through
pipelines, tankers would be acceptable provided the source remains the same.

Note 1: It is the responsibility of the manufacturer to ensure that the source of raw water
remains the same. An undertaking in this regard shall be obtained from the manufacturer.

Note 2: Raw water supplies received through tankers, river, lake, pond etc. is acceptable,
provided treatment of such water is done as mentioned in 3.1.1.

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3.1.3 As indicated above, in the manufacturing of the packaged drinking water, remineralization
may also be done. This process involves addition of ingredients. In case remineralization is carried
out by any manufacturer, ingredients used for the purpose shall be of food grade/pharmaceutical
grade quality.

Note: With respect to the conformity of ingredients used for remineralization to food
grade/pharmaceutical grade, original manufacturer’s declaration through labels or
certificate/test certificate from a BIS approved laboratory as per relevant Indian Standard or
IP/NFP/USP/BP requirements, in this respect will be accepted.

3.1.4 Processed water may be disinfected by means of chemical agents and/or physical methods to
control the micro-organisms to a level that does not compromise food safety or suitability for
consumption. Various means adopted for disinfection include ozonation, ultraviolet treatment,
silver ionization, etc. and/or combination thereof.

3.2 Packaged Natural Mineral Water

3.2.1 Packaged natural mineral water shall be water obtained directly from natural or drilled
sources from underground water-bearing strata.

3.2.2 Packaged natural mineral water is collected under conditions which guarantee the original
microbiological purity and chemical composition of essential components and subjected to
permitted treatments which include separation from unstable constituents, such as compounds
containing iron, manganese, sulphur or arsenic, by decantation and/or simple filtration, if necessary,
accelerated by previous aeration. No disinfection process is permitted.

Note: Only simple filtrations through filters of pore size not finer than 0.5 microns which do
not change the composition of the source water are permitted. Processes like reverse
osmosis, activated carbon bed filtration etc. are not permitted.

3.2.3 Packaged natural mineral water shall be packaged close to the point of emergence of the
source with particular hygienic precautions.

3.2.4 The transport of natural mineral water in bulk container is prohibited.

3.2.5 Natural mineral water shall have the constancy of its composition and the stability of its
discharge and temperature, due account being taken of the cycles of minor natural fluctuations.
Evidences for constancy of water composition at source on account of cycles of minor natural
fluctuations during different seasons in a year shall comprise of the following:

a) Test report (from any BIS approved OSL) of all the major seasons covering major physico-
chemical parameters;

b) Record of temperature at discharge point/ point of emergence (by manufacturer);

c) The reports of all the seasons shall be reasonably comparable and conforming to IS 13428; and

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d) Report from the Hydrogeologist covering genesis of natural mineral water; period of its
residence in the ground; chemical, physical and radiological qualities; and the risk of pollution.

3.3 Packaging

3.3.1 The packaged water shall be packed in clean, hygienic, colourless, transparent, tamperproof
and sealed containers of various types/sizes/ made from plastic materials as permitted in either IS
13428 or IS 14543. Containers with features like Cool Jugs, Jugs with built-in taps, Jars with
threaded (reusable) caps without seal etc. shall not be permitted. Single-use disposable/collapsible
jars are also not permitted

3.3.2 There are many terminologies presently adopted by the industry and consumer for describing
the different packaging containers of packaged water. For the purpose of uniformity in describing the
various types of containers, descriptions as given in Table 1 have been derived. In case of change in
material (i.e., PET/PC) it shall be treated as separate type (ex. PET Jar,PC Jar).

Table 1: Description of Containers for Packaged Water

CONTAINER DESCRIPTION

Jars Reusable plastic containers with capacity above 5 litres

Plastic Bottles One time use plastic containers with capacity upto and
including 5 litres.

Cup/Tumbler One time use plastic container in cup shape or tumbler

(glass shape) with a peelable seal

Glass Bottle Reusable containers made of glass material.

Pouches Flexible Pouches made from plastic films.

3.3.3 The standards prescribe use of colourless and transparent containers. Therefore tinted
containers are not permitted.

Note: Use of HDPE containers had been discontinued after 31 July 2003, as communicated
by CMD-II vide note dated 01 08 2003 and 01 10 2003.

3.3.4 Cup/tumbler/pouch shall be filled with drinking water/natural mineral water followed by heat
sealing of cup/tumbler with peelable seal through automatic process. Manual filling and sealing shall
not be allowed so as to maintain hygiene and sanitation. Manual loading of packaging material
(cup/tumbler) may be accepted.
3.4 Assessment of Hygienic Conditions

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Guidelines for assessment of hygienic conditions with explanatory notes have been given at Item 6
for the inspecting personnel.

4. GRANT OF LICENCE

4.1 General

4.1.1. This section gives the guidelines on actions related to receiving of an application and its
processing for grant of licence (GOL). The pre-requisites for GOL shall be as per the requirements
published in BIS website, (www.bis.org.in) either for normal procedure or for simplified procedure.

4.1.2 Application for grant of licence for packaged water shall be accompanied by the list of
documents given in BIS Web site (www.bis.org.in). An application under simplified procedure shall
be accompanied with original test reports of PDW/PNMW as per relevant specifications and on
entire range of containers, their materials, caps and closures for which GOL has been requested.

4.2 Recording of Application

An application with its enclosures shall be scrutinized as per the check-list given in Annex 1.
Recording shall be done when all pre-requisites have been addressed in the application with
supporting documents.

4.3 Inspection

4.3.1 The format for Preliminary Inspection Report specific to PDW/PNMW shall be as given at
Annex 2, in case of application received under normal procedure.

4.3.2 The verification by BIS Inspecting Officer shall be reported in the format specific to
PDW/PNMW and as given at Annex 3, in case of application received under simplified procedure.

4.3.3 Aspects to be inspected

During preliminary inspection/verification visit, for assessing capabilities of the applicant

organization, with respect to manufacturing and testing facilities; competence of Quality Assurance
Personnel and hygienic conditions, following shall be verified:

a) Correctness of documents and declarations submitted with the application and self evaluation
report (in case of application under simplified procedure);

b) Availability of all manufacturing facilities including filling and/or packaging machinery;

c) Process capability, starting with collection of raw water to packaged water including
intermediate checks;

d) Filling and packing capabilities for all capacities and types of containers used in packaging
of water;

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e) Availability of required testing facilities, as per the relevant ISS. List of test equipment and
chemicals required for testing of packaged water is given at Annex 9.

f) For testing certain requirements, as specified in the STI, the applicant may avail the
provision of STI for getting some tests done from outside BIS recognized laboratories
(OSL), if in-house facilities are not available. The applicant shall furnish an undertaking that
they shall get samples tested as per the frequency of STI at any BIS recognized laboratory
(test requirements which are to be conducted once in a month or beyond shall only be
permitted to be tested at OSL);

g) Competence of Quality Assurance Personnel. There shall be at least two (2) Quality
Assurance Personnel, one of whom shall be a Chemist, the other a Microbiologist. For
further details, 4.7 shall be referred;

h) Compliance to Hygienic Practices as per Annex B of IS 13428:2005 or Annex B of IS

14543:2004 ( Item 6 of this Manual);

i) Availability of adequate storage facility for raw water, finished product and packaging
materials, keeping in view the installed capacity of the firm for packaging in 24 hours and
storage capacity of finished product for 48 hours;

j) The correctness of plant layout with respect to following:

i) Source of raw water and raw water storage facility

ii) pipeline, storage tanks etc;

iii) Plant for the manufacture of PDW and/or PNMW, as the case may be (with various
process stages);

iv) Filling/packing/loading/ unloading areas;

v) Storages for packaging material and finished product

;
vi) Entry/exit with indications of double door/door closures/air curtains, wherever
provided;

vii) Laboratory;

viii) Actual boundary/perimeter of the establishment;

ix) change room, toilet(s), whether the premises also used for residential/other purposes,
with identified locations.

Note: A typical manufacturing process; process flow chart; CIP process for plant and
machinery and pipelines; and cleaning process for reusable jars are given at Annex 5.

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4.3.4 Hygiene Practices

Hygienic practices in the plant shall be verified as per Annex B of IS 13428:2005 or Annex B of IS
14543:2004 ( Item 6 of this Manual and Annex 4). Explanatory notes provided at the end for
guidance only.

4.4 Sample for Independent Testing

4.4.1 Packaged Water (Packaged Drinking Water and/or Packaged Natural Mineral Water)

One sample of packaged water shall be drawn and sent for complete testing for all requirements
of the relevant Indian Standard.

4.4.1.1 In case the applicant is adopting more than one type of processes/sources of raw water,
separate samples shall be drawn for each process/source.

4.4.1.2 In the event of more than one bore well /open well located in the same premises, they shall
be considered as a single source for the purpose of drawing of sample of PACKAGED DRINKING
WATER as well as for exercising quality control, provided there is only one processing line.

4.4.1.3 Samples shall be drawn in sealed containers only, which shall not be leaking. During
sampling, the container of packaged water sample shall never be opened for any purpose as the
water will get contaminated.

4.4.2 Packaging Material

4.4.2.1 When an application is received under normal procedure for GOL, during preliminary
inspection, along with one sample of packaged water, samples of all containers,( of each type, each
size and each material) and their material (for example, film with pouch) shall be drawn for
complete testing as per IS 15410 and/or IS 15609 as applicable and for which application has been
made to include in the licence

4.4.2.2 When an application has been received under simplified scheme, during verification
inspection by BIS officer before GOL, one sample (any one size, type and material) for one type of
container shall be drawn for complete testing as per IS 15410 and/or IS 15609 respectively..

4.4.3 Sample Size

4.4.3.1 Packaged Water

a) For all parameters other than radio active residues - A sample containing approximately
18 litres of packaged water (PDW/PNMW) is adequate, if packed in 2 litres or smaller containers
but in case the samples are available in large size packages, minimum two such packages are

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required as microbiological laboratory needs separate sample for ensuring aseptic handling. For
example:

Capacity of Numbers
bottle/Jar in litres to be
drawn
1 18
2 9
5 4
10 2
20 2
24 2

Pouches: 2 bags of 100 pouches each + Film. A sample of 4 bags shall be drawn in case
each bag contains 50/60 pouches.

b) For Parameters concerning Radio-active Residue

In addition to the above, sample shall also be drawn for testing parameters concerning radio active
residues. A sample of 10 litres is adequate.

Note: If a fresh application has been submitted after closure of earlier application or
expiry/cancellation of earlier licence and the closure of application/licence was for reasons
other than failure in radioactive residues, fresh sample of water need not be drawn for testing
of radioactive residues, if evidence is available that the source of raw water remained the
same as that in earlier application/licence, provided that radioactive residue TR of the sample
drawn by BIS during verification visit passes and is not older than two years. The earlier test
reports of sample drawn by BIS (not older than two years) shall be accepted within a period
of two years.

4.4.3.2 Sample of packaging material (containers)

PET Bottles upto 2 litres – 18 Empty (with caps) + 12 filled

5 litres – 12 Empty (with caps) + 9 filled
10 litres & above – 6 Empty (with caps) + 3 filled

Pouches: 4 bags of 50/100 pouches each + one meter film used for making the pouches. Cup/Glass
along with peelable seal: 25 Empty + 25 filled + lids (25)

Note 1: The pouches shall be made in the presence of BIS officer, during inspection, and
may be printed with only details like batch number, date of manufacturing, best before date,
capacity, using ink to be used by the manufacturer for marking on the pouches. This will
facilitate testing of pouches for ink adhesion test and product resistance test. This is being
allowed as manufacturer can not get the pouch film rolls printed with all other details such as
Standard Mark etc. before the GOL.

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 Note 2: As there is presently no Indian Standard for glass bottle/tumbler, such containers
need not be tested. However, if any manufacturer intends to use such container, it shall be
included in the licence.

4.4.4 Samples shall not be drawn for independent testing for the following:

a) Product Durability Assessment (shelf life study), and

b) Raw Water Requirements

4.5 Test Request and Selection of Laboratory

4.5.1 Masking of sample

Effort shall be made, as far as possible, to send samples without the manufacturer’s identification
and/or markings. Any label and/or manufacturer's identification from the bottles/Jars shall be
removed or defaced.

4.5.2 Test request

Test request shall clearly indicate the following:

a) Date of processing/packing;

b) Best Before Date;

c) Quantity (in litre or milliliter),

d) Type, material and capacity of container

e) Declared wall thickness of container(s)/width of film of pouch

4.5.3 Selection of laboratory for independent testing:

Samples shall be tested either at a BIS laboratory or BIS recognized laboratory .List of recognized
laboratories is given on BIS website. Selection of laboratory for independent testing shall be as per
provisions of OMPC.

4.6 Verification of Calibration of Test Equipment

4.6.1 Records of calibration of test equipment need to be maintained by the applicant.

Although the test equipment will depend upon the selection of test method by the applicant from the
options available in the respective Indian Standard, calibration of following test equipment is
considered necessary at least once a year. The calibration certificates shall be from NABL
accredited laboratory or from laboratory having traceability to national level.

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 a) Analytical balance (electronic)/weight box (including fractional weights),

b) Temperature indicators of all incubators,

c) Pressure gauge of Autoclave, and

d) Temperature indicator of Autoclave (optional)

4.6.2 Other instruments, such as spectrophotometer, turbidity meter, pH meter are to be

standardized as per the standard operating procedures supplied with respective instrument.

4.7 Quality Assurance Personnel

4.7.1 There shall be minimum two Quality Assurance Personnel, one for carrying out chemical
testing and the other for microbiological testing.

4.7.2 The personnel for chemical testing shall be minimum science graduate with chemistry as one
of the subjects. Microbiologist shall be a science graduate with preferably Botany or Microbiology
as a subject or a graduate in Food Technology/science or Dairy Technology/science or Agriculture.
Both shall have necessary competence to carry out testing of the respective tests (chemical or
microbiological).

4.7.3 The IO shall witness all possible tests that can be conducted during the inspection. For those
tests which are not possible to be carried out during inspection, assessment of competence may be
made through interview of the testing personnel, demonstration of initiation of tests, equipment,
interpretation of results etc., which shall be suitably recorded in IR.

4.8 STI

Acceptance of existing scheme of testing and inspection (STI) shall be obtained from the applicant
during the inspection visit, if the same has not been received earlier.

4.9 Marking Fee

Acceptance of existing rate of marking fee shall be obtained from the applicant during the inspection
visit, if the same has not been received earlier.

4.10 Processing for Grant of Licence

The Red Form shall be put up as per the check-list given in Annex 6 with all attached documents
serially page-numbered. In case of GOL under normal procedure, if the product water is conforming
and failure(s) of Container samples are reported, grant of licence shall be processed for the product
water as per IS 14543/IS 13428, as the case may be along with the remaining container(s) which
have been reported as passing.

Note 1 under 2.9.1 of OMPC is not applicable in such cases.

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4.11 Scope of Licence

Licence shall be granted with scope specifying the type(s) and material(s) of container(s) permitted
to be used for packing the product. Licence shall not be granted with “open scope”. A container
shall be included in the licence subject to availability of proof of conformity to the relevant Indian
Standard for each of such container(s). The grant of licence letter and the Licence Document shall
clearly indicate the following:

a) Packaged Natural Mineral Water/ Packaged Drinking Water with corresponding Indian
Standard;

b) Type of each container (Jar, Bottle, Cup/Tumbler, Pouch);

c) Material of construction of each container (PC/PET/PP/PS/PE/Glass);and

d) Size/Capacity of the container.

(see Clause 3.3.2 for Guidelines for above classification)

5 OPERATION OF LICENCE

5.1 General

This section provides guidelines for operation of licence based on IS 13428 or IS 14543 and the
corresponding Scheme of Testing and Inspection. The operational guidelines as given under
Operating Manual for Product Certification shall be followed for those situations that are not
specifically covered in this Manual.

5.2 Periodic (Surveillance) Inspection

At least two surveillance inspections are required to be done in an operative year of a licence, as per
the requirements of the BIS (Certification) Regulations, 1988. The inspections shall be planned in a
manner to evenly spread over during the period of a licence’s validity. A surveillance inspection
shall not be done after validity of a licence is over and decision is pending for its renewal. The report
of surveillance Inspection of a packaged water licensee shall be submitted as per the format given at
Annex 7 along with Hygiene Checklist as given at Annex 8.

5.2.1 Scheme of testing & inspection(STI)

The STIs for IS 13428 and 14543 as in force shall be applicable. The implementation of STI shall be
verified during surveillance inspection.

5.2.2 Marking fee

The details of rate of marking fee are available on BIS intranet/website.

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5.2.3 List of laboratories for independent testing

The list of BIS laboratories and laboratories recognized by BIS, where sample of packaged water
and/or its container can be sent for independent testing, are available on BIS intranet/website. The
inspecting officer/agent shall collect latest status in respect of any laboratory before proceeding for
inspection.

5.2.4 Sample from factory and market

Sample of packaged water shall be drawn during surveillance inspection from the available stock or
from production with Standard Mark observed during such inspection (FS). Two FS shall be drawn
and independently tested during an operative period of a licence (drawing one sample during one
inspection). Four market samples (MS) of packaged water shall also be drawn during an operative
year of the licence. Samples of containers and packaging materials are also required to be drawn for
testing by rotation pertaining to various containers as permitted in the licence as it is essential to
monitor the quality of container(s) being used for filling with packaged water. The details of
samples that should be drawn in one operative year of a licence are given in Table 2 and Table 3:

Table 2 - Sampling from Factory during surveillance inspection

Particulars of No. of Details of tests to be conducted

sample sample(s)
FS 2 During the operative period, at least one
FS/MS shall be tested for all requirements
including pesticide residues.
Note: One FS shall be tested every two
(2) years for parameters concerning
radio-active residues. If FS could not be
drawn for testing for Radioactive residues
due to any reason then, MS shall be tested
for the same

Container 1 From the first periodic inspection

/surveillance visit (verification visit by
BIS in case of GOL under simplified
procedure) onwards, one sample of any
one type of container ( one size and
material) shall be tested once a year for all
requirements of relevant Indian Standard.
Sampling of container shall be done in a
manner so as to cover all type, sizes &

15
 material on rotational basis during the
operation of the licence. Sample of
container shall be drawn at the same time
when a FS is being drawn.

Table 3 - Sampling from Market

Particulars of No. of Details of tests to be conducted

sample sample(s)
MS 4 All 4 MS shall be tested for all
requirements of the Indian Standard,
except for pesticides residues and
parameters concerning radio-active
residues. Also refer Table 2 above for FS

5.3 Hygienic Conditions

Plant, process and personnel hygiene shall be assessed during every surveillance inspection as per
Hygienic Practices at Annex B of IS 14543:2004 or Annex B of IS 13428:2005 (Item 6 of this
Manual). The filled up Checklist (Annex 8 of this Manual) also shall be attached with Surveillance
Inspection Report.

5.4 Operational Issues

5.4.1 Change of source of raw water or change in process

5.4.1.1 Packaged natural mineral water

In case of change of source of raw water by the licensee, documentary evidence shall be collected as
stated under 3.2.5 of this Manual and examined vis-à-vis the requirements of IS 13428 for constancy
of source water quality. An inspection shall be carried out to verify that the restrictions specified in
the standard with respect to processing and disinfection are complied; to verify plant machinery and
to check hygienic conditions. A sample of packaged natural mineral water produced by using
changed source shall then be drawn for independent testing for its conformity to all requirements of
the standard including parameters concerning radio-active residues. CM/PF 305 shall be submitted
by the licensee and countersigned by the inspecting official after due verification of declarations
made therein. Permission for use of Standard Mark shall be given on receipt of test reports
indicating conformity of the sample.

5.4.1.2 Packaged Drinking Water

In case of change of source of raw water by the licensee, an inspection shall be carried out to verify
the changes made in processing of raw water, if any; to verify plant machinery and to check
hygienic conditions. CM/PF 305 shall be prepared by the licensee and countersigned by the
inspecting official after due verification of details. A sample of packaged drinking water produced

16
by using changed source shall then be drawn for independent testing for its conformity to all
requirements of the standard including parameters concerning radio-active residues. Permission for
use of Standard Mark shall be given on receipt of test reports indicating conformity of the sample.
Clause 4.4.1.2 of this manual may also be referred.

5.4.1.3 Concurrent use of raw water from two different sources

In case of concurrent use of raw water of two different types of sources (for example water being
extracted through own bore-well and also obtained from municipal source), the production from
each source shall be assigned a different batch number and separately tested as per STI for
conformity of the product water, provided production lines are separate. Accordingly, records of
production and testing of packaged drinking water produced using both the sources shall be kept by
the licensee. However, when there is more than one source of raw water but processing plant is one,
testing of packaged drinking water shall be done after duly verifying the additional source(s) being
introduced and appropriate record in CM/PF 305, if necessary shall be made. Such testing shall
include parameters concerning radio-active residues.

5.4.2 Change in the process

In case of any addition, alteration and/or change in the production process without any change in
raw water source (for example, remineralization has been added after reverse osmosis in production
of packaged drinking water or decantation has been introduced as a process step in production of
packaged natural mineral water), necessary verification of plant and machinery shall be done with
duly filling up of CM/PF 305. A sample is required to be drawn for independent testing for its
conformity to the relevant Indian Standard, except for parameters concerning radio-active residues,
before permitting the same to be marked. Testing of product water so produced by using different
processes shall be carried out as per STI and records be kept separately by the licensee.

Note 1: Testing for parameters concerning radio-active residues need not be done
under above circumstances provided the source of raw water remains the same.

Note 2: Any change in process may require fresh approval of label. Therefore
licensee shall be advised to prepare fresh label incorporating all marking details and
obtain approval.

5.4.3 Shelf-life

The shelf-life of packaged natural mineral water/packaged drinking water shall be minimum
30 days. If the manufacturer intends to declare a longer shelf-life than minimum 30 days,
study shall be conducted on each type of packing at least once a year or whenever there is a
change in the source of raw water/manufacturing/packing process, whichever is earlier. The
shelf-life period shall be declared on the labels suitably as “Best for consumption within ----
-days or -----months from the date of packing” based on the shelf life studies (but not less
than 30 days). Subsequently, for any change in the shelf life declared on the labels, the
manufacturer shall inform BIS in advance along with shelf- life study reports and submit
fresh label for approval. Tests to be carried out for shelf life studies are requirements given

17
in Table 1 of IS 14543/IS13428 along with routine microbiological tests as per IS
14543/IS13428.

5.4.4 Change in the scope of licence

5.4.4.1 Extension of scope

There are many instances when licensees request for permitting use of additional types of
packaging materials/filling capacities, although basically the packaged water may remain
the same (i.e., other than those related to remineralization). These may be considered based
on the following:

Under Normal Procedure

a) Packing/filling/cleaning and disinfection (in case of reusable containers) arrangements

related to proposed inclusion such as required infrastructure, filling facilities, flow
process and intermediate checks etc., are verified and recorded on CM/PF305;

b) Associated hygienic conditions are verified, if applicable;

c) Raw water shall not be tested;

d) Sample for shelf-life test shall not be drawn. Only declaration in this regard shall be
obtained; and

e) Sampling of container for independent testing should be done as follows:

Irrespective of whether, the test certificate of containers with respect to conformity to IS 15410 or
15609, as applicable, is available or not, sample of each type/ size/material shall be drawn for
complete testing. Endorsement to the licence shall be issued for including the particular type of
container in the licence after sample of such container is found conforming to the standard.

Under Simplified Procedure

For inclusion under the simplified procedure, in case the licensee submits the complete test report of
containers from OSL along with modified process flow chart if any, additional infrastructure
facilities if required, intermediate checks etc., inclusion as per the simplified procedure shall be
permitted without any further testing. The variety so included may be drawn for independent testing
during subsequent visits on rotational basis, so as to cover the entire range and the changes intimated
shall be verified during the subsequent visit.
The licensee shall submit an undertaking that in case of failure of sample in independent testing, he
shall abide by the instructions of BIS for stop marking/withdrawal of permission to use the particular
type of container/cancellation of licence, as the case may be.

5.5 Stop Marking - Resumption of Marking

18
The procedure given in OMPC shall be followed.

5.6 Handling Complaints on Packaged Water

5.6.1 As the packaged water is meant for mass consumption and also related directly to the health
and safety of the consumer, it is quite likely that complaints may arise for the same. The product is
not expensive. Therefore, as per the OMPC a replacement can straight away be arranged to the
complainant. However, the following aspects need to be addressed suitably.

5.6.2 Redressal to the complainant may be arranged either from the existing stock (if declared to be
conforming) or from the fresh production after resumption of marking is permitted to the licensee (in
case Firm is under stop marking for any reason or has been placed under stop marking due to
complaint or any other reason).

5.6.3 If it is not possible to establish the complaint by visual examination, it would be necessary to
send material under complaint for independent testing. However, if the container has already been
opened and the packaged water is not available in originally packed condition, it shall not be sent for
testing. Only unopened sealed container (packing with intact cap/closure/seal) shall be sent for tests.
Attempts may be made to procure material pertaining to the same lot/batch/manufacturing date from
the market, if available and sent for independent testing to establish the complaint. However, such
sample purchased from the market shall not have the status of complaint sample but would only be
treated as a market sample and would be handled in the manner in which any other market sample is
handled.

5.6.4 The above procedure is to be followed in addition to the procedure of handling of complaints
as given in the OMPC.

6 GUIDELINES FOR ASSESSMENT OF HYGIENIC CONDITIONS IN PACKAGED

DRINKING WATER UNIT WITH EXPLANATORY NOTE (BASED ON IS 14543:2004)

REQUIREMENT OF INDIAN EXPLANATORY NOTES FOR

STANDARD GUIDANCE
B-1 FIELD OF APPLICATION
The hygienic practices cover the appropriate
general techniques for collecting drinking
water, its treatment, bottling, packaging,
storage, transport, distribution and sale for
direct consumption, so as to guarantee a
safe healthy and whole some product.
B-2 HYGIENE PRESCRIPTIONS FOR COLLECTION OF DRINKING WATER
B-2.1 Extraction or Collection It may be ensured that the ground water source
is reasonably away from any polluting source
In the case of extraction or collection of like drain/ sewer/ septic tank.
water intended for packaging from ground
water sources, it should be ensured that it is Ground water source (whether owned/ shared)
safe from pollution, whether caused by shall be under the direct control and supervision

19
natural occurrence or actions or neglect or of the manufacturer. Clear declaration from the
ill-will. manufacturer for ensuring that the ground water
source is safe from pollution either by natural
occurrence or because of action/ neglect/ ill-will
shall be taken.
B-2.2 If water to be processed for packing is
obtained from any other potable source it
should be protected from being
contaminated.
B-2.3 The firms using waters from drinking
water systems intended for packaging
should ensure that it meets the requirements
of the standard.
B-2.4 Materials The material should preferably be of stainless
The pipes, pumps or other possible devices steel. However, GI or plastic material may also
coming into contact with water and used for be used. In case of plastic materials, it should
its collection should be made of such be supported with certificate for its food-grade
material that they do not change the quality quality. Rubber pipe shall not be permitted.
of water.
B-3 PROTECTIVE MEASURES
B-3.1 All possible precautions should be The surrounding of the source water outlet
taken within the protected perimeter to should be completely covered with pucca
avoid any pollution of, or external influence construction to avoid contamination due to
on, the quality of the ground or surface ingress of external causes. If it is at ground
water. Preventive measures should be taken level then it should be covered with a boundary
for disposal of liquid, solid or gaseous waste wall upto an adequate height.
that could pollute the ground or surface
water. Drinking water resources should not
be in the path of potential source of
underground contamination.
B-3.2 Protection of the Area of Origin
The immediate surroundings of the Outlets of bore well/ well heads should be
extraction or collection area should be covered and locked.
protected by limiting access to authorized Units should prevent entries of individuals,
persons only. Wellheads and spring pests and other sources of extraneous matter to
outflows should be protected by a suitable the immediate surroundings of source of water.
structure to prevent entry by unauthorized
individuals, pests and other sources of
extraneous matter.
B-4 TRANSPORT OF DRINKING WATER
B-4.1 Means of Transport, Piping and Water from the source to processing unit may
Reservoirs be transported through pipes.
Any vehicle, piping or reservoir used in the Piping used should preferably be of SS.
processing of water from its source to the However, food grade plastics or GI may also be
bottling facilities, should be made of inert permitted. Rubber pipe should not be permitted.
material such as ceramic and stainless steel Reservoir should preferably be of SS. In case

20
which prevent any deterioration, be it by of plastic reservoir, inside layer should be of
water, handling, servicing or by food grade plastic (certificate may be
disinfection; it should allow easy cleaning. collected). Cemented (underground/
overground) reservoir should be properly tiled
from inside.
B-4.2 Maintenance of Vehicles and The design of reservoir should be such as to
Reservoirs enable easy cleaning or disinfection and it
Any vehicle or reservoir should be properly should be properly maintained throughout the
cleaned and, if necessary, disinfected and operation of licence.
kept in good repair so as not to present any
danger of contamination to drinking water
and of deterioration of its quality.
B-5 ESTABLISHMENT FOR PROCESSING OF DRINKING WATER – DESIGN AND
FACILITIES
B-5.1 Location The unit should not be in low lying area to
Establishments should be located in areas avoid collection of dust, contaminant, rain and
which are free from objectionable odours, flood water.
smoke, dust or other contaminants and are Factories in open area/ field should have its
not subject to flooding. proper boundaries with controlled access.
B-5.2 Roadways and Areas Used by Areas in front of main entry to the unit and
Wheeled Traffic immediate surroundings should be paved
Such roadways and areas serving the (pucca) or properly grassed to prevent dust
establishment which are within its contamination due to vehicular traffic.
boundaries or in its immediate vicinity
should have a hard paved surface suitable
for wheeled traffic. There should be
adequate drainage and provision should be
made for protection of the extraction area.
B-5.3 Buildings and Facilities
B-5.3.1 Type of construction Buildings should be sound pucca construction,
Buildings and facilities should be of sound preferably plastered and properly painted/ white
construction and maintained in good repair. washed. Internal partitions made of plastic may
be accepted.
B-5.3.2 Disposition of Holding Facilities The manufacturing area should not be permitted
Rooms for recreation, for storing or for general residence or recreation purposes.
packaging of water and areas for cleaning of In case of any duty quarters for workers/
containers to be reused should be apart from residential area, the same should be reasonably
the bottling areas to prevent the end away from the plant and clearly demarcated and
products from being contaminated. Raw maintained.
materials and packaging materials and any Area for cleaning of reusable containers,
other materials which come into contact packaging material and storage of finished
with drinking water should be stored apart water should be separate from processing/
from other material. filling area. All types of packaging materials
should be stored in a separate room/ area.
B-5.3.3 Adequate working space should be Sufficient space should be available for easy
provided to allow for satisfactory movement in different operations of

21
performance of all operations. manufacturing.
B-5.3.4 The design should be such as to
permit easy and adequate cleaning and to
facilitate proper supervision of hygiene for
drinking water.
B-5.3.5 The buildings and facilities should There should not be any other activity except
be designed to provide separation by production and packing of water. In case
partition, location or other effective means similar products like cold drink/ beverages/
between those operations which may cause soda are also manufactured in the same
cross-contamination. premises, these activities should be clearly and
entirely separated from water manufacturing
and packing facilities. However, for such food
items manufacturing, use of processed water
through a separate pipe line and separate plant
and machinery may be permitted.
There should be proper separation between
different processing activities like blowing of
bottles/ storage of containers: cleaning of
reusable containers: raw water storage tank:
filtration (ROs/Micron) disinfection and filling.
Exhaust of laboratory should not open in
processing/ filling area.
B-5.3.6 Buildings and facilities should be As far as possible the flow of air should be from
designed to facilitate hygienic operations by filling room to the outer area and not the other
means of a regulated flow in the process way round.
from the arrival of the drinking water at the
premises to the finished product, and should
provide for appropriate conditions for the
process and the product.
B-5.3.7 Drinking Water Handling, Storing and Bottling Areas
B-5.3.7.1 Floors The flooring should be smooth, without any
Where appropriate, should be of water- cracks/ broken surfaces. Joints shall be
proof, non-absorbent, washable, non-slip properly filled and smooth. The slope of the
and non-toxic materials, without crevices, flooring in processing and filling area should be
and should be easy to clean and disinfect. such as to avoid any stagnation of water. The
Where appropriate, floors should have inside drains, if kept open, should be properly
sufficient slope for liquids to drain to tiled for easy and effective cleaning. Drains
trapped outlet. should always be in clean condition and
provided with traps to prevent the entries of
rats/ pests.
B-5.3.7.2 Walls In case of cemented walls, tiles upto height of
Where appropriate, should be of water about 5 to 8 feet from floor level should be
proof, non-absorbent, washable and non- provided. Wall made of smooth plastic
toxic materials and should be light coloured. material may be accepted.
Up to a height appropriate for the operation
they should be smooth and without crevices,

22
and should be easy to clean and disinfect.
Where appropriate, angles between walls,
between walls and floors and between walls
and ceilings should be sealed and smoothen
to facilitate cleaning.
B-5.3.7.3 Ceilings Ceiling should preferably be pucca cemented
Should be so designed, constructed and and smooth. However, factories with tin/
finished as to prevent the accumulation of aluminum/ asbestos shed should have proper
dirt and minimize, condensation, mould smooth false ceiling made of non absorbent
growth and flaking, and should be easy to material (like plastic). Wood or similar
clean. material should not be used as it may attract
fungal/ mould growth.
B-5.3.7.4 Windows Open windows should not be permitted.
Windows and other openings should be so Windows shall be provided with net screens
constructed as to avoid accumulation of dirt which are easily cleanable and moveable.
and those which open should be fitted with Fittings shall be so intact as to prevent entry of
screens. Screens should be easily movable mosquitoes/ flies.
and cleaning and kept in good repair.
Internal window sills should be sloped to
prevent use as shelves.
B-5.3.7.5 Doors Each door should have door closure. Air
Should have smooth, non-absorbent curtains should preferably be provided at
surfaces and, where appropriate, be self- different entries including all inlets and outlets
closing and close fitting type. of filling room. The surface of doors should be
of non absorbent material.
B-5.3.7.6 Stairs, lift cages and auxiliary All stairs, lifts, chutes and ladders should be of
structures sound construction and properly painted.
Platforms, ladders, chutes, should be so
situated and constructed as not to cause
contamination to drinking water. Chutes
should be constructed with provision of
inspection and cleaning hatches.
B-5.3.7.7 Piping Different colour coding should be provided so
Piping for drinking water lines should be as to easily distinguish between different pipe
independent of non-potable water. lines. The pipe line meant for potable water
should preferably be green in colour. The
entire pipe line for production water including
joints after RO shall be made of stainless steel.
The joints should preferably be of dairy fitting
type.
B-5.3.8 In drinking water handling areas all In case false ceiling is provided, care should be
overhead structures and fittings should be taken to periodically clean the same and it
installed in such a manner as to avoid should be ensured that ceiling is perfect
contamination directly or indirectly of (without any breakage/ seepage) at all times.
drinking water and raw materials by
condensation and drip and should not

23
hamper cleaning operations. They should
be insulated where appropriate and be so
designed and finished as to prevent the
accumulation of dirt and to minimize
condensation, mould growth and flaking.
They should be easy to clean.
B-5.3.9 Living quarters, toilets and areas
where animals are kept should be
completely separated and should not open
directly on to drinking water handling areas.
B-5.3.10 Where appropriate, Entry to different water processing area should
establishments should be so designed that be controlled in such a way that only the
access can be controlled. authorized persons have the access.
B-5.3.11 The use of material which cannot Wood in any form should not be used in
be adequately cleaned and disinfected, such processing and filling area.
as, wood, should be avoided unless its use
would not be a source of contamination.
B-5.3.12 Canalization, Drainage Lines The drainage line of plant should have proper
Canalization and drainage and used water slope and should be made of material which
lines should be built and maintained in such facilitate easy cleaning. There should not be
a manner as not to present any risk any stagnation of water/ effluent.
whatsoever of polluting the underground The main drainage line of the plant should be of
water source. . sound structure, fully covered and should open
outside the plant only, away from underground
water source.
B-5.3.13 Fuel Storage Area
Any storage area for the storing of fuels,
such as, coal or hydrocarbons should be
designed, protected, controlled and
maintained in such a manner as not to
present a risk of pollution during the storage
and manipulation of these fuels.
B-5.4 Hygienic Facilities
B-5.4.1 Water Supply
B-5.4.1.1 Ample supply of potable water Conformity of raw water is for guidance only.
under adequate pressure and of suitable It should be ensured that the source of raw
temperature should be available with water (potable) remains uniform. The use of
adequate facilities for its storage, where raw water from different sources shall not be
necessary, and distribution with adequate done unless permitted (see Section 5 of the
protection against contamination. The
manual). However in case of change of source,
potable water should conform to IS 10500. provisions of STI shall be followed.
In order to monitor the uniform supply of raw
water, testing of the same should be carried out
as per the frequency prescribed in STI and
records be maintained.
B-5.4.1.2 Potable water, non-potable water See Explanatory notes against Cl. B-5.3.7.7

24
for steam production or for refrigeration or
for any other use should be carried in
separate lines with no cross connection
between them and without any chance of
back siphonage. It would be desirable that
these lines be identified by different
colours.
B-5.4.2 Effluent and Waste Disposal Pipe line carrying the effluent and waste should
Establishments should have an efficient preferably be of red in colour.
effluent and waste disposal system which
should at all times be maintained in good
order and repair. All effluent lines
(including sewer system) should be large
enough to carry the full loads and should be
so constructed as to avoid contamination of
potable water supplies.
B-5.4.3 Changing Facilities and Toilets Entrance to the production unit should be
Adequate, suitable and conveniently located through change room.
changing facilities and toilets should be Change room should have hand washing
provided in all establishments. Toilets facilities (with hot and cold water) wash basin,
should be so designed as to ensure hygienic foot cleaning and drying facilities. Protective
removal of waste matter. These areas clothing, footwear and head gear should be
should be well lighted, ventilated and changed inside the change room only. The
should not open directly on to drinking protective clothings should be taken out as and
water handling areas. Hand washing when workers go out of the production hall, so
facilities with warm or hot and cold water, a as to prevent any contamination of the same.
suitable hand-cleaning preparation, and with Toilets should be provided for workers and
suitable hygienic means of drying hands, should always be kept clean. These should be
should be provided adjacent to toilets and in properly separated from water handling areas.
such a position that the employee will have Toilets should be made of pucca structured
to use them when returning to the preferably tiled with proper doors and water
processing area. Where hot and cold water facilities. Hand and foot washing facilities
are available mixing taps should be should be provided adjacent to toilets.
provided. Where paper towels are used, a Notices giving instructions for hand and foot
sufficient number of dispensers and washing after using toilets (in local languages)
receptacles should be provided near each should be pasted at proper places.
washing facility. Care should be taken that
these receptacles for used paper towels are
regularly emptied. Taps of a non-hand
operatable type are desirable. Notices
should be posted directing personnel to
wash their hands after using the toilets.
B-5.4.4 Hand Washing Facilities in See explanatory notes against Cl. No. B-5.4.3
Processing Area
Adequate and conveniently located facilities
for hand washing and drying should be

25
provided wherever the process demands.
Where appropriate facilities for hand
disinfection should also be provided.
Warm or hot and cold water should be
available and taps for mixing the two should
be provided. There should be suitable
hygienic means of drying hands. Where
paper towels are used, a sufficient number
of dispensers and receptacles should be
provided adjacent to each washing facility.
Taps of a non-hand operatable type are
desirable. The facilities should be furnished
with properly trapped waste pipes leading to
drains.
B-5.4.5 Disinfection Facilities Disinfection of pipe lines and process
Where appropriate, adequate facilities for equipments should preferably be done before
cleaning and disinfection of equipment commencement of production.
should be provided. These facilities should
be constructed of corrosion resistant
materials, capable of being easily cleaned,
and should be fitted with suitable means of
supplying hot and cold water in sufficient
quantities.
B-5.4.6 Lighting Intensity of light is given only for guidance.
Adequate lighting should be provided However the IO should judge the adequacy of
throughout the establishment. Where light intensity required for carrying out various
appropriate, the lighting should not alter activities.
colours and the intensity should not be less Suspended light bulbs and fixtures should be
than: protected by providing suitable covers.
540 lux (50 foot candles) at all inspection
points,
220 lux (20 foot candles) in work rooms,
and
110 lux (10 foot candles) in other areas.
Suspended light bulbs and fixtures in any
stage of production should be of a safer type
and protected to prevent contamination of
drinking water in case of breakage.
B-5.4.7 Ventilation Exhaust openings should be covered with
Adequate ventilation should be provided to wiremesh or with suitable flaps. Air curtains
prevent excessive heat, steam condensation should be fitted in such a way that air should
and dust and to remove contaminated air. not flow towards water filling room/ area.
The direction of the air flow should never
be from a dirty area to a clean area.
Ventilation openings should be provided
with a screen or other protecting enclosure

26
of non-corrodible material. Screens should
be easily removable for cleaning.
B-5.4.8 Facilities for Storage of Waste Facilities for storage of waste and inedible
and Inedible Material material should be outside the processing plant
Facilities should be provided for the storage and finished product storage area.
of waste and inedible material prior to
removal from the establishment. These
facilities should be designed to prevent
access to waste or inedible material by pests
and to avoid contamination of drinking
water; equipment, buildings or roadways on
the premises.
B-5.5 Equipments and Utensils
B-5.5.1 Materials
All equipment and utensils used in drinking
water handling areas and which may contact
the drinking water should be made of
material which does not transmit toxic
substances, odour or taste, is non-absorbent,
is resistant to corrosion and is capable of
withstanding repeated cleaning and
disinfection. Surfaces should be smooth
and free from pits and crevices. The use of
wood and other materials which cannot be
adequately cleaned and disinfected should
be avoided except when their use would not
be a source of contamination.
B-5.5.2. Hygienic Design, Construction and Installation
B-5.5.2.1 All equipment and utensils should
be so designed and constructed as to prevent
hazards and permit easy and thorough
cleaning and disinfection.
B-6 ESTABLISHMENT
B-6.1 Maintenance
The buildings, equipments, utensils and all
other physical facilities of the
establishment, including drains, should be
maintained in good repair and in an orderly
condition.
B-6.2 Cleaning and Disinfection
B-6.2.1 To prevent contamination of All equipments and utensils should be cleaned
drinking water, all equipment and utensils and preferably disinfected, every day before
should be cleaned as frequently as necessary commencement of production.
and disinfected whenever circumstances
demand.
B-6.2.2 Adequate precautions should be See explanatory note as given in B-5.4.5

27
taken to prevent drinking water from being
contaminated during cleaning or
disinfection of rooms, equipment or
utensils, by wash water and detergents or by
disinfectants and their solutions.
Detergents and disinfectants should be
suitable for the purpose intended. Any
residues of these agents on a surface which
with may come in contact with drinking
water should be removed by thorough
rinsing with water, before the area or
equipment is again used for handling
drinking water.
B-6.2.3 Either immediately after cessation
of work for the day or at such other times as
may be appropriate, floors, including drains,
auxiliary structures and walls of water
handling areas should be thoroughly
cleaned.
B-6.2.4 Changing facilities and toilets Changing facilities like aprons, headgears,
should be kept clean at all times mask etc. should be available in sufficient
numbers to meet daily and contingency
requirement.
B-6.2.5 Roadways and yards in the The area surrounding the unit may be grassed to
immediate vicinity of and serving the prevent entry of dirt and dust in the plant.
premises should be kept clean. Construction of wall of adequate height
(approximate 8 feet) is required when the
immediate surrounding is not in the control of
the unit.
B-6.3 Hygiene Control Programme
A permanent cleaning and disinfection The hygiene control programme should cover
should be drawn up for establishment to all aspects.
ensure that all areas are appropriately An elaborate hygiene control plan should be
cleaned and that critical areas, equipment drawn for monitoring the hygienic conditions of
and material are designated for special the plant and personnel. The plan should
attention. An individual, who should invariably include the following:
preferably be a permanent member of the Hygiene requirement
staff of the establishment and whose duties Frequency
should be independent of production, should Name of the person directly responsible for
be appointed to be responsible for the supervision
cleanliness of the establishment. He should The above plan should be monitored by a
have a thorough understanding of the designated person who has thorough
significance of contamination and the understanding of significance of contaminants
hazards involved. All cleaning personnel and hazards.
should be well-trained in cleaning The hygiene control schedule should be
techniques. properly displayed at different points like

28
 processing/ filling/ storage.
B-6.4 Storage and Disposal of Waste
Waste material should be handled in such a See explanatory notes as given in Cl. B-5.4.2
manner as to avoid contamination of
drinking water. Care should be taken to
prevent access to waste by pests. Waste
should be removed from the water handling
and other working areas as often as
necessary and at least daily. Immediately
after disposal of the waste, receptacles used
for storage and any equipment which has
come into contact with the waste should be
cleaned and disinfected. The waste storage
area should also be cleaned and disinfected.
B-6.5 Exclusion of Animals
Animals that are uncontrolled or that could No animal should be allowed inside the plant
be a hazard to health should be excluded area. If any stray intrusion of pest like lizard,
from establishments. flies are found, immediate action shall be taken
to remove them and further necessary
preventive measures shall be taken.
B-6.6 Pest Control
B-6.6.1 There should be an effective and Pest control measures should preferably be got
continuous programme for the control of done through professional agencies with clear
pests. Establishments and surrounding area indication of validity period, through a
should be regularly examined for evidence certificate for the same. Fly catchers should be
of infestation. provided in processing/ filling area.
B-6.6.2 If pests gain entrance to the Pesticides designated safe for use in food
establishment, eradication measures should industry should only be used under direct
be instituted. Control measures involving supervision of trained personnel.
treatment with chemical, physical or
biological agents should only be undertaken
by or under direct supervision of personnel
who have a thorough understanding of the
potential hazards to health resulting from
the use of these agents, including those
hazards which may arise from residues
retained in the drinking water.
B-6.6.3 Pesticides should only be used if See explanatory note as given in Cl. B—6.6.2
other precautionary measures cannot be
used effectively. Before pesticides are
applied, care should be taken to safeguard
drinking water, equipment and utensils from
contamination. After application,
contaminated equipment and utensils should
be thoroughly cleaned to remove residues
prior to be used again.

29
B-6.7 Storage of Hazardous Substances
B-6.7.1 Pesticides or other substances
which may present a hazard to health should
be suitably labeled with a warning about
their toxicity and use. They should be
stored in locked rooms or cabinets, and
dispersed and handled only by authorized
and properly trained personnel or by
persons under strict supervision of trained
personnel. Extreme care should be taken to
avoid contamination.
B-6.7.2 Except when necessary for hygienic
or processing purposes, no substance which
could contaminate drinking water should be
used or stored in drinking water handling
areas.
B-6.8 Personal Effects and Clothing
Personal effects and clothing should not be Protective clothing should not be permitted to
deposited in drinking water handling areas. be taken out beyond change room. Separate
cabinets for storage of personal belongings
should preferably be provided.
B-7 Personnel; Hygiene and Health Requirements.
B-7.1 Hygiene Training
Managers of establishments should arrange
for adequate and continuing training of all
water handlers in hygienic handling of
water and in personal hygiene so that they
understand the precautions necessary to
prevent contamination of drinking water.
B-7.2 Medical Examination
Persons who come into contact with Medical examination of all workers, testing
drinking water in the course of their work personnel and supervisors should be got done at
should have a medical examination prior to least once in a year or as and when required. In
employment, if the official agency having case any new worker joins, his fitness with
jurisdiction acting on medical advice, respect to freedom from communicable diseases
considers that this is necessary, whether should be first medically examined before
because of epidemiological considerations permitting work in water processing area.
or the medical history of the prospective
water handler. Medical examination of
water handlers should be periodically
carried out and when clinically or
epidemiologically indicated.
B-7.3 Communicable Diseases
The management should take care to ensure Medical examination report should clearly
that no person, whether known or suspected indicate that the workers are free from any
to be suffering from, or to be a carrier of a communicable diseases.

30
disease likely to be transmitted or afflicted
with infected wounds, skin infections, sores
or diarrhea, is permitted to work in any
drinking water handling area in any capacity
in which there is any likelihood of such a
person directly or indirectly contaminating
drinking water with pathogenic micro-
organisms. Any person so affected should
immediately report to the management.
B-7.4 Injuries
Any person who has a cut or wound should Availability of first aid box should be ensured.
not continue to handle drinking water or
contact surfaces until the injury is
completely protected with a waterproof
covering which is firmly secured and which
is conspicuous in colour. Adequate first-aid
facilities should be provided for this
purpose.
B-7.5 Washing of Hands
Every person, while on duty in a drinking Foot operated or photo sensitive taps may
water handling area, should wash the hands preferably be used.
frequently and thoroughly with a suitable
hand cleaning preparation under running
warm water. Hands should always be
washed before commencing work,
immediately after using the toilet, after
handling contaminated material and
whenever necessary. After handling any
material which might be capable of
transmitting disease, hands should be
washed and disinfected immediately.
Notices requiring hand-washing should be
displayed. There should be adequate
supervision to ensure compliance with this
requirement.
B-7.6 Personal Cleanliness
Every person engaged in a drinking water Wearing of protective clothing should be
handling area should maintain a high degree ensured when the plant is in operation.
of personal cleanliness while on duty and
should, at all times while so engaged, wear
suitable protective clothing including head
covering and footwear, all of which should
be cleanable, unless designed to be disposed
off and should be maintained in a clean
condition consistent with the nature of the
work in which the person is engaged.

31
Aprons and similar items should not be
washed on the floor. When drinking water
is manipulated by hand, any jewellery that
cannot be adequately disinfected should be
removed from the hands. Personnel should
not wear any insecure jewellery when
engaged in handling drinking water.
B-7.7 Personal Behaviour
Any behavior which could result in Proper notices in this regard should be
contamination of drinking water, such as displayed in local languages at appropriate
eating, use of tobacco, chewing (for places.
example, gum, sticks, betel nuts, etc.) or
unhygienic practices, such as, spitting,
should be prohibited in drinking water
handling areas.
B-7.8 Visitors
Precautions should be taken to prevent General visitors should be prohibited for
visitors as far as possible from visiting the entering into processing area.
drinking water handling areas. If
unavoidable, the visitors should observe the
provisions of B-6.8 and B-7.3
B-7.9 Supervision
Responsible for ensuring compliance by all Hygiene supervisor should be other than the
personnel with the requirements of B-6.1 to one responsible for production. However, the
B-6.8 and the responsibility should be overall supervision for requirements of B-6.1 to
specifically allocated to competent B-6.8 may be done by a senior person
supervisory personnel. irrespective of actual work area.
B-8 ESTABLISHMENT: HYGIENIC PROCESSING REQUIREMENTS
B-8.1 Raw material Requirements
To guarantee a good and stable quality of See explanatory note given in Cl. B-5.4.1.1
drinking water, the quality criteria should be
monitored regularly.
B-8.2 Should there be a perceptible lacking
in meeting the requirements, necessary
corrective measures are immediately to be
taken.
B-8.3 Treatment
The treatment may include decantation, IO should specifically report the type of
filtration, combination filtration (for processes adopted by the firm for production
example, membrane filters, depth filters, and disinfection..
cartridge filters, activated carbon), Any subsequent change in the process should
demineralization, reverse osmosis, aeration, be positively informed to BIS for action (see
and disinfection. Section 5 of Manual)
B-8.3.1 Processing should be supervised by
technically competent personnel.
B-8.3.2 All steps in the production process, The water processed in a day should be filled/

32
including packaging, should be performed
without unnecessary delay and under
conditions which will prevent the possibility
of contamination, deterioration, or the
growth of pathogenic and spoilage micro-
organisms.
B-8.3.3 Rough treatment of containers
should be avoided to prevent the possibility
of contamination of the processed product.
B-8.3.4 Treatment are necessary controls
and should be such as to protect against
contamination or development of a public
health hazard and against deterioration
within the limits of good commercial
practice.
B-8.4 Packaging Material and Containers
B-8.4.1 All packaging materials should be
stored in a clean and hygienic manner. The
material should be appropriate for the
product to be packed and for the expected
conditions of storage and should not
transmit to the product objectionable
substances beyond the limits specified. The
packaging material should be sound and
should provide appropriate protection from
contamination. Only packaging material
required for immediate use should be kept
in the packing or filling area.
B-8.4.2 Product containers should not have
been used for any purpose that may lead to
contamination of the product. In case of
new containers if there is a possibility that
they have been contaminated, they should
be cleaned and disinfected. When
chemicals are used for these purposes, the
container should be rinsed. Containers
should be well drained after rinsing. Used
and, when necessary; unused containers
should be inspected immediately before
filling.
B-8.5 Filling and Sealing of Containers
B-8.5.1 Packaging should be done under
conditions that preclude the introduction of
contaminants in the product.
packed on the same day. The left out processed
water should be either drained or reprocessed
(on the subsequent day).
Reusable containers where transparency or
shape is impaired because of repeated use,
should be rejected.
Separate stores should be available for
packaging material, finished products and other
items. Containers/ bottles received or blown by
the firm should preferably be stored in a closed
mouth polybag/ caps to avoid any
contamination.
The reusable containers and caps should be
cleaned, disinfected, washed and jet rinsed
(with processed water) before filling.
Various options are available for disinfection
like use of chlorinated water (using
hypochlorite), food grade detergents like
Ranocide etc. However, use of disinfectants
(one or a combination) should be left to the
discretion of the manufacturer. Due care should
be taken that no residue of disinfectant is left in
the pipeline/ container.
Filling room should be regularly disinfected.
For this purpose, various options may be
assessed such as use of UV light, filling under
sterile positive pressure etc. However, selection
of disinfectant should be left at the discretion of
33
 manufacturer.
Air conditioner may also be provided in the
filling room, if required in view of ventilation/
environmental conditions of the area.
B-8.5.2 The methods, equipment and To ensure tight and impervious sealing, the
material used for sealing should guarantee a shrinkable sleeve may be used on caps and the
tight and impervious sealing and should not container may be held upside down to check for
damage the containers nor deteriorate the any leakage. The above method is suggestive.
physical, chemical, microbiological and However, any other suitable method may be
organoleptic qualities of drinking water. used.
The container should be visually inspected for
any suspended particle etc. against an
illuminated screen.
B-8.6 Packaging of Containers
The packaging of containers should protect The reusable containers may preferably be
the latter from contamination and damage wrapped in a plastic (polyethylene) film/ bag to
and allow appropriate handling and storing. avoid any damage/ transparency to the
container. Every time new polyethylene cover
should be used.
B-8.7 Lot Identification
Each container shall be permanently marked The date of manufacturing should be clearly
with code to identify the producing factory indicated on the container itself, in one straight
and the lot. A lot is quantity of drinking line instead of any other combination which
water produced under identical conditions, may not be consumer friendly.
all packages of which should bear a lot Writing of batch No. in place of manufacturing
number that identifies the production during date should not be practiced unless it is declared
a particular time, interval and usually from a that batch number and manufacturing date are
particular ‘processing line’ or other the same.
processing unit.
B-8.8 Processing and Production Records
Permanent, legible and dated records of Batch wise records of production and dispatch
pertinent processing and production details for each type of container should be maintained
should be kept concerning each lot. These separately.
records should be retained for a period that
exceeds the shelf life of the product or
longer if required. Records should also be
kept of the initial distribution by lot.
B-8.9 Product Durability
Product durability shall be declared on the Product durability should not be less than one
container as per 7.1 (g). It shall be based on month. Each type of container should be
in-house shelf life study and proper checks subjected for durability assessment and based
and records be maintained for the on the study conducted by the manufacturer, the
conformity of the declared product shelf life should be declared. Records of the
durability. same should be maintained and may be verified
by IO.
Decision about the type of study should be left

34
 with the manufacturer.
Durability study should be reassessed by the
licensee at least once in a year for each type of
container.
B-8.10 Storage and Transport of the End-Product
The end-product should be stored and The finished product should not be stored under
transported under such conditions as will direct sun light.
preclude contamination with and/or Manufacturer should invariably exercise to
proliferation of micro-organisms and protect inspect the end product available in distribution
against deterioration of the product or chain to ensure its compliance to the
damage to the container. During storage, specification. This may be done either directly
periodic inspection of the end-product or through proper arrangements with their
should take place to ensure that only dealer/ distributor.
drinking water which is fit for human Manufacturer should provide proper training to
consumption is dispatched and that the end- the distributor/ marketer for its proper storage
product specifications are complied with. and distribution. Manufacturer is liable for the
product quality till it reaches the consumer.

7. USEFUL TIPS FOR INSPECTING PERSONNEL

7.1 To verify the actual factory layout. The layout should clearly indicate the different locations
preferably including the following:

a) Bore well or entry point for the source of raw water, pipeline etc.

b) Raw water storage facility

c) Plant for the manufacture of the product (with various stages)

d) Filling/packing areas, change room, toilet(s), loading/unloading points

e) Entry/exit with indications of double door/door closures/Air curtains wherever provided

f) Stores for packaging material and finished product

g) Laboratory

h) Actual boundary/perimeter of the establishment

i) If the premises are also used for residential quarters/other purposes, then specific mention of the
same be made with identified locations.

7.2 As product is under mandatory certification, it is unlikely to be in “production” during PI. It

is therefore essential to get some production & filling/packing done during the visit and then make
comments on the firm’s capability for the same.

35
7.3 It should be clearly reported in the PIR as to whether the filling/packaging adopted are
manually operated or automatic. It may be noted that the plastic cups, tumbler, pouch are required to
be filled only through automatic machine.

7.4 Sample be got tested in factory for some requirements possible to be tested, with purpose of
verifying manufacturing capability (process controls), competence of the QC personnel and working
conditions of test equipment.

7.5 For sample drawn for independent testing, requirement of Description, Odour & Taste should
be tested and reported in PIR, as these are subjective tests.

7.6 Shelf-Life (“Best Before”) Period should be clearly indicated on the test request.

7.7 STI requires holding material till such time the test results for Each Control Unit are known.
However in case of microbiological parameters each batch of Packaged drinking water is required to
be held for 48 hours so as to ensure that it conforms to all the microbiological parameters applicable
for each control unit except for the tests of aerobic microbial count at 210 C and yeast and mould,
which shall be reviewed for conformity on availability of their test reports after 72 hours and 5 days
respectively.Therefore it is important to assess the firm’s installed production capacity as well as
capability to “store” the product. Accordingly both the production capacity and storage facility need
to be reported.

7.8 Hygienic conditions need to be assessed as per every clause of Annex B of ISS. Declarations
made by the firm with respect to medical examination, Pest Control, Hygiene Schedule, Supervisor
designated for Hygiene maintenance, Overall Supervision, Criteria devised for assessing product
durability etc. be verified and reported.All aspects related to reusable containers, availability of
arrangements for washing, cleaning (outer surface), disinfection and rinsing be also verified and
reported.

7.9 Sample size for Testing of Packaged Drinking Water for Independent Testing

7.9.1 For all requirements except radio-active residues

Approximate 18 litre quantity is adequate if the samples are supplied in 2 litre or smaller containers
but in case the samples are available in large size packages, minimum two packages are required as
microbiological lab needs separate sample for ensuring aseptic handling. For example:

Capacity of Numbers
bottle/Jar in litres to be
drawn
1 18
2 9
5 4
10 2
20 2
24 2

36
7.9.2 For Radio-active residues

Approximate 10 litre quantity: one carton of bottles (containing 12 bottles/ cups) or one jar (of 10
litres and above) is adequate.

7.10 Guidelines for Reused Containers

Licensees are required to ensure use of only such jars whose transparency continues to meet the
minimum requirements of 85% as per IS 15410 even after its repeated use. BO may draw sample of
reusable container for ascertaining continued suitability over a period of time by getting the same
tested for transparency requirement. Every market sample of processed water filled in reusable jar
shall be got tested for transparency requirement also as per IS 15410. Jars which get deshaped and
mutilated during the course of use shall not be permitted. Licensees may be advised in this regard
strictly. Further action may be taken as per OMPC.

37
 ANNEX 1
(Clause Ref. 4.2)

CHECK LIST FOR SCRUTINY OF APPLICATION

PACKAGED DRINKING WATER (IS 14543) &
PACKAGED NATURAL MINERAL WATER (IS 13428)

A. CHECKPOINTS Complies (Yes/No)

1 Application is submitted with the required Fees
2 Complete Office address & Manufacturing address are given
3 Manufacturing address in various documents is same
4 Composition of Top Management is indicated and tallying with other
documents submitted with application (such as at 1, 6 etc.)
5 Copy of Partnership Deeds, List of Director etc., as applicable
6 Copy of Registration of the firm (if applicable)
7 Documentary evidence submitted for status as Small Scale etc
8 Type, Material and Capacity is clearly indicated
9 Brand Name Declaration
a) CM/PF 307 is submitted
b) Copies of agreements with Brand owners are submitted (wherever
applicable)
10 Plant Machinery declaration is submitted on CM/PF 305
11 Test Equipment
a) Declaration submitted on CM/PF 306 (covering equipment, glassware,
chemicals and media)
b) Least Count, Range and quantity of equipment are as per ISS
c) Calibration reports of required equipment are submitted
d) Consent letter from approved OSL is submitted for testing of
requirements for which in-house facilities are not available
12 Personnel for Chemical & Microbiological Test
a) Whether copies of appointment letters submitted
b) Whether qualification of personnel are in order
c) Whether copies of qualification certificates submitted
13 Raw Water-Permissible source of raw water is used
14 Details regarding procurement/manufacturing facilities for packing
materials are submitted
15 Details of Manufacturing Process with Treatment for Disinfection and
Process Flow Chart are submitted
16 Factory Layout Plan indicating locations of important facilities (source
water, processing stages, disinfection, packing, storing, testing etc) is
submitted
17 Location and Route Map to factory is submitted
18 Production Figures for previous/current periods (as applicable)
19 Installed Capacity is clearly indicated
20 Acceptance of STI is submitted/ indicated

38
21 Acceptance to pay Marking Fees is submitted/indicated
22 Hygienic Conditions – whether copies of reports submitted for
a) compliance to Annex B
b) medical examination of concerned staff
c) Pest Control Treatment (if got done from outside source
23 Declaration submitted for Shelf-Life of product packed in all
containers
24 Details of previous application/licence provided, as applicable
25 Whether request made for blocking of Licence No. If so, whether Indemnity
Bond submitted
B CHECKPOINTS SPECIFIC TO NORMAL PROCEDURE Complies(Yes/No)
1 Whether date for preliminary inspection is proposed
2 Whether details of samples being offered for inspection (water and
packaging materials) are indicated
C CHECKPOINTS SPECIFIC TO SIMPLIFIED PROCEDURE Complies(Yes/No
1 Whether Self-Evaluation Report submitted
2 Original Test Report for Water & Containers
a) Whether the reports submitted are from approved Labs
b) Whether the reports are not older than 30 days
3 Whether undertaking for compliance to Labeling Prohibition
submitted
4 Whether undertaking submitted for stoppage of marking in case of
failure of verification sample in independent testing

Any other details/comments

Recommendations of Dealing Officer

Sign. Dealing Officer

Name
Date

Decision of Group Leader

39
 CM/PF 201
Sept 1995

ANNEX 2
(Clause Ref. 4.3.1)

BUREAU OF INDIAN STANDARDS

REPORT OF PRELIMINARY INSPECTION

Application No. CM/A- IR No.. . . . . . . . ..

IS Date of writing IR . . . . . . .

Product

Type/ Size/Grade/Variety

1. GENERAL INFORMATION

a) Applicant’s Name

b) Address: i) Factory

ii) Office:

c) Date of inspection

d) Situation of factory

e) Telephone/Fax i) Factory

ii) Office
2. Management Staff

3. Person(s) contacted

4. BIS Licences, if any, held by the applicant

________________________________________________________________________
REMARKS OF THE REVIEWING OFFICER (ON IRS, TRS , GENERAL ETC)

_____________________________________________________________________________

40
 (2)

CM/PF 201
Sept 1995
5. RAWMATERIALS

a) Raw Materials Used:

Sl. No. Raw Material Name of With or Test

How
Supplier Without Certificate
Received
BIS Certi- of the
Batches/
fication Supplier
Lots
Mark Nature of
Package
____________________________________________________________________________

b) Arrangement for testing

as received

c) Details of sampling

d) Methods of disposal of
sub-standard raw materials

e) Record of tests with

proforma of records

6. MANUFACTURE

a) Type/ Size/Grade/Variety being

manufactured at the time
of inspection

b) Description of the process from

raw material to finished product
stage ready for dispatch (Also
enclose Layout plan of the factory)

41
 (3)

CM/PF 201
Sept 1995
c) Intermediate points where control
is exercised

d) Details of records maintained and

control used

e) Method(s) of disposal of sub-standard products

f) Units of production

g) Production per day or per shift

h) Details of manufacturing machinery

(See proforma PF 305 Annexed)

i) Technical comments on the manufacturing

capabilities and inprocess controls

7. PACKING AND MARKING

a) Nature of packing

b) Quantity per package

c) Marking on article

d) Method of marking (printing,

stenciling, embossing etc)

e) Form of label(s), if any

f) Batch or Code numbering for

identification

g) In what manner marking differs

from the provisions in the Indian Standard
Specification

42
 (4)

CM/PF 201
Sept 1995
8. LABORATORY AND INSPECTION

a) Details of Staff:

Sl. No. Name of Qualification Experience

Person
____________________________________________________________________________

b) Competency of testing
personnel

c) Equipment and other

facilities for complete
specification testing.
Test equipment/chemicals
not available

d) Accuracy of instruments and

arrangements for calibration

e) Records maintained in
laboratory for routine tests:

Sl. No. Requirement/Characteristic Value

____________________________________________________________________________

f) Stage of processing where

laboratory reports are made
available

g) Sampling and testing of end

products

43
 (5)

CM/PF 201
Sept 1995
9. SAMPLE

a) Source of drawl: stock/production

b) Size of lot from which sampled

c) Type/ Size/Grade/Variety of the sample

d) Details of the counter sample left with the firm

e) Manner of packing, labeling, coding and sealing

f) How sealed ? Give impression of the seal used

g) Laboratory to which dispatched

h) Test results on a sample tested in the factory:

Requirements Value Value Remarks

Tested Obtained Recorded
By Firm

i) Any further information

regarding sample drawn

j) Information regarding sample of

other type/grade/variety applied for

k) Comment in the testing capabilities

44
 (6)

CM/PF 201
Sept 1995

10. OTHER INFORMATIONS

a) Main buyers and selling price

b) Storage facilities

c) Hygienic conditions (in case of

food products, give complete note
as per relevant hygienic code)

d) Discussion with the firm on:

e) STI and marking fee rate

i) The manner of putting the

Standard Mark

ii) Manner of manufacture and

dispatches without Standard
Mark in case of stoppage of
marking

11. INSPECTION/TESTING CHARGES Collected/Not Collected

12. CONCLUSIONS, RECOMMENDATIONS

AND POINTS FOR ACTION

Signature:

No. of Encl.: Inspected by:

(Name)

Designation:

Station: Date:

45
 ANNEX 3
(Clause Ref. 4.3.2)

VERIFICATION REPORT BY BIS INSPECTING OFFICER

(The Inspecting Officer(s) shall give technical comments on manufacturing capability, in process
controls, competency of testing personnel and testing capability. Any discrepancy observed during
verification at factory shall be conveyed formally through D/V Report)

1. Application No. :

2. Applicant :

3. Address :

4. Date of Visit :

5. IS No. :

6. Product :

7. Person(s) Contacted:

8. VERIFICATIONS

S.No Aspect Verification Observation *

.
a Manufacturing Applicant’s declaration on PF 305 be verified Complete or
Facilities for completeness and correctness and Incomplete
countersigned
b Manufacturing Applicant’s declaration regarding process, Conforming or Non
process filling and packing be verified for correctness conforming
including filling and countersigned
and packing
c Testing Applicant’s declaration on PF 306 be verified Complete or
Facilities for completeness and correctness and Incomplete
countersigned
d Requirements Copy of consent letter from OSL including Available and
for which each requirement and frequency specified in complete or not
Testing facilities STI, be obtained and enclosed with this available/incomplete
are not available report
e Factory Testing Sample be got tested in factory and test report Sample Pass or Fail
be submitted in format Annex-3A
d Competence of Competence be assessed for Microbiological Q.C competent or
Q.C. personnel and Chemical testing through factory testing, Not competent
interview etc.

46
f Hygienic Assessment be made as per Annex B of the Satisfactory or
Conditions Indian standard and reported using Annex 4 Needs improvement
of this manual duly countersigned by IO and
applicant’s Hygiene Incharge .

* In case the observations are not satisfactory for any of the aspects and for which actions are required to
be taken by the applicant, details be given in D/V Report.

9. SAMPLES FOR INDEPENDENT TESTING

a) Details of samples drawn for independent testing be given in the Annex-3 B.

Whether left with the applicant for dispatch to Lab or brought to office?

10. ACCEPTANCES & DECLARATIONS BY THE APPLICANT

S.No. Subject Whether already Whether

submitted obtained now
Yes No Yes * N.A.
a Acceptance of STI
b Acceptance of Marking Fee
c Brand Name Declaration with Copies
of Agreement, if applicable
d Undertaking for stoppage of marking
if verification sample fails in
independent testing

* Documents which are obtained during verification visit be Annexed with the report, duly marked.

11. ANY OTHER POINT/COMMENT (Give details of verification of other actions taken by
applicant on advise rendered by BIS based on scrutiny of application or otherwise asked for, if any)

12. RECOMMENDATIONS

13. POINTS FOR ACTIONS (Give details of all actions required to be taken by the applicant as
per deficiencies indicated on the D/V Report)

Signature
Name
Designation
Date
Group Leader

47
 ANNEX 3A

FACTORY TESTING REPORT

P D water/ P NM Water

Manufacturing Date

Batch No. (if applicable)

Type of Container from which sample drawn

Quantity in stock pertaining to above Batch/Mfg. Date

IS Requirement Specified Value Observed Value

S.No. clause
Ref.

Result : Pass for the requirements tested or Fail in the requirement(s) ……

(strike out whichever is not applicable)

Signature

Name

Designation Chemist Microbiologist

Representing (BIS) Firm:

48
 ANNEX 3B

SAMPLES FOR INDEPENDENT TESTING

1. Sampling of P D Water or PNM Water

a) Source of drawl (Stock/production)

b) Size of lot (quantity) from which sample is drawn with details of type/material/Capacity

c) Batch No. (if applicable) and Mfg. Date of Water

d) Declared shelf-life

e) Quantity drawn (indicate no. of packing & capacity)

f) Code assigned to the sample (Give separate codes for samples sent to different Labs., such as for
chemical & radiological)

g) Manner of packing, labeling and sealing

h) Tests to be carried out and name of the Lab. where sample is to be tested (Chemical, Physical,
Microbiological, Radiological)

2. Sampling of Packaging Material for Water

a) Type, Material and Capacity of container(s)

b) IS No. and Standard

c) Size(s) of lot(s) from which sample(s) drawn

d) Quantity drawn (indicate no. of packing & capacity)

e) Declared parameters (Width of PE Film, Wall Thickness of plastic container)

e) Code assigned to the sample

f) Manner of packing, labeling and sealing

g) Tests to be carried out and name of the Lab. where sample is to be tested

3. Details of counter samples left with the firm:

49
 ANNEX 4

(Clause 4.3.4 and 4.3.6)

CHECKLIST FOR GOOD HYGIENE PRACTICES AND FOOD SAFETY SYSTEMS FOR
PACKAGED NATURAL MINERAL WATER PROCESSING UNITS AS PER CLAUSE 5 OF
IS 13428:2005 OR CHECKLIST FOR GOOD HYGIENE PRACTICES AND FOOD SAFETY
SYSTEMS FOR PACKAGED DRINKING WATER PROCESSING UNITS AS PER
CLAUSE 4, ANNEX C OF IS 14543:2004 (TO BE VERIFIED BY IO DURING
PRELIMINARY/VERIFICATION VISIT)

Sl. Requirements Answers Remarks (briefly

No. Satisf- Unsatis describe how required
actory factory is met or not )
A Building, Facilities and Locations
i) Is the facility located in an area free from
objectionable odour, smoke, dust or other
contaminants and not subject to flooding?
ii) Are the areas immediately surrounding the
buildings, roads, parking places, suitably
paved, grassed and kept clean?
iii) Is adequate facility for drainage of
surroundings available and designed to handle
peak load?
iv) 1s the facility used for processing water free
from domestic animals?
v) Are the facility surroundings free from refuse,
waste materials, rubbish, over grown weeds
and grasses?
vi) Are there adequate facilities for the disposal
of effluents and wastes?
vii) Are the buildings and facilities of sound
construction and maintained in good repair?
viii) Are the buildings and facilities designed and
maintained to prevent entrance and harboring
of pests and entry of contaminants?
ix) Are building and facilities designed to
facilitate hygienic operations?
B. Plant and Physical Facilities
i) Is adequate lighting provided at working
station, hand washing area, and storage areas?
ii) Is the lighting intensity adequate:1) 540 lux in
all inspection area, and 2) 220 lux in work
areas and walls

50
iii) Are light fixtures safety types and protected to
prevent contamination in the event of
breakage in the processing and packing area?
iv) 1s adequate ventilation provided in processing
areas to minimize odours, noxious fumes and
condensates?
v) Are barrier traps provided at drains to prevent
the entry of rodents from the drains into the
facility?
vi) Is effective screening provided against entry
of birds, animals, insects, rodents, etc
vii) Are doors, hatches and other openings to the
building constructed in such a way to render
opening pest proof?
NOTE — Installation of one or more of the
following, which effectively prevents pest
entry, will meet this requirement:
a) Doors self closing type,
b) Have air curtains, and
c) Have strip curtains.
viii) Are floors, walls, ceilings, windows and doors
so designed and constructed as to prevent
accumulation of dust, dirt and render them
washable?
ix) Is product in process and storage area
adequately protected from any leakage from
external surfaces and other sources of
contamination?
x) Are immediate surroundings of extraction or
collection protected from entry of
unauthorized persons?
C Raw Water Processing
i) In case of extraction /collection for processing
are the sources free from contaminations/
impurities?
ii) Are water storage tanks, pipe lines utilized for
handling water constructed and so designed as
to facilitate cleaning and inspection?
iii) Are inspections of containers/ carriers/
pipelines of raw water supply performed for
the material of construction and cleanliness?
iv) Are possible chances of contamination from
incoming water assessed?
v) Are water storage tanks effectively cleaned to
prevent entry of pests and potential

51
 contaminator?
vi) Are the storage tanks periodically cleaned and
records maintained?
vii) Are the processed water contact surfaces
regularly cleaned and sanitized?
viii) Are all equipment and utensils so designed
and constructed as to prevent hygiene hazards
and allow easy cleaning and sanitation?
D Post-Processing Handling
i) Are cleaning operations of bottles/containers
so done as to preclude contamination of
product and product contact services with
residues?
ii) Has absence of residual cleaning chemicals
been ensured?
iii) Is preventive maintenance in place for all
processing machinery and equipment?
iii) Are the primary packing material and
containers of food grade conforming to
relevant Indian Standards?
iv) Are packing and sealing, where required,
monitored?
v) Are containers visually/electronically
inspected for their soundness?
vi) Are physical hazards prevented from entering
into processed water?
vii) Are glassware excluded from production
area?
E Packaging Material and Finished Goods
Storage
i) Are the primary packing material and
containers of food grade conforming to
relevant Indian Standards?
ii) Are packaging material inspected to ensure
their suitability?
iii) Are the packing materials especially primary
packing material properly stored and properly
handled to preclude contamination?
iv) Are packaging material purchased, stored and
handled in sanitary manner?
F Finished Product Storage and Distribution
i) Is first-in-first out (FIFO) of stored product
maintained?
ii) 1s storage properly sanitized and disinfected
periodically?

52
iii) Are stores protected from pest infestations?

iv) Are coding and tracking clear and in place?

v) Are the instructions clear and in place?
vi) Are hold release procedure in place and
product identified?
vii) Are the records maintained for batch number,
date and volume of production?
viii) Are transport containers/vehicles maintained
in clean condition?
G Customer Handling of Products
i) Are the storage instructions provided on
containers?
ii) Is the shelf life period (best before) mentioned
on containers in accordance with PFA
requirements?
iii) Are instructions provided for handling
defective/ damaged products?
H Sanitary Facilities and Control
i) Are toilet provided in sufficient numbers and
are they provided with:
1) Doors of self closing type?
2) Opening directly into processing areas?
3) Hand washing signs provided in
appropriate language?
4) Proper lighting and ventilation?
5)Proper maintenance to keep in clean and
tidy manner?
ii) Are hand washing facilities provided
adequately and conveniently to wash hands,
foot, elbow with sensor operated taps?
iii) Are germicidal soaps / soap solution and hand
drying facility provided?
iv) Are notice/instructions prominently pasted in
toilet directing employees to wash their hands
on entry and re-entry into the food handling
areas?
v) Are the refuse receptacles, self closing type,
maintained in a manner to protect from
J Personnel Hygiene and Habits
i) Is any individual assigned to supervise overall
sanitation of plant and personnel?
ii) Is there any person responsible for day-to-day
monitoring of health and hygiene?

53
iii) Have the employees in processing, packing
and maintenance been medically examined?
iv) Are the personnel with infectious diseases,
skin infection and open lesion or any other
source of microbial contamination excluded
from working in process/packing areas?

v) Are personnel hygiene practices regularly

maintained and monitored?
1) Clean outer garments — protective
clothing?
2) Personal cleanliness — finger nails?
3) Head cover— hair restraints, caps, head
bands, beard cover
4) No tobacco in any form— smoking,
chewing
5) No eating at work stations
vi) Are protective clothing stored on the premises
and not allowed to be used for outside wear

vii) Are there clear legible notices defining limits

of no smoking areas such as “NO SMOKING
BEYOND THIS POINT” displayed?
viii) Are personnel imparted regular training or
hygienic food handling, processing food and
personal hygiene?
ix) Are unsecured jewellery and other objects,
such as, wrist watches, cufflinks, ear rings,
glass bangles, stick BINDIS removed at
work?

CONCLUSION: OVERALL ASSESSMENT OF HYGIENIC CONDITIONS -

SATISFACTORY / NOT SATISFACTORY

NAME OF UNIT Signature ………………….….

CM/A.............. Name ..……………
Designation …………………..
Date…………………….

54
 ANNEX 5
(Clauses 1.1, 4.3.3)

A TYPICAL MANUFACTURING PROCESS

Following treatment steps are involved in the manufacturing process for packaged drinking water:

Raw Water →Raw Water Storage Tank→ Raw Water Feed Pump→ dosing system 1 & 2→ Pressure
Sand Filter→ Activated Carbon Filter → Micron Cartridge Filter High Pressure Pump→ Reverse
Osmosis→ Ozone generator and re circulation → Finished Water Storage → U.V System → Filling
and Packing → Visual Examination →Storage for testing → Forwarding.

1) DOSING SYSTEM 1 & 2 - The water is drawn from Bore Well or any source and collected in
storage tank. It then goes to dosing system through raw water feed pump with use of antiscalant
for softening the water.

2) PRESSURE SAND FILTER - From softener, the water is transferred to pressure sand filter for
removing the impurities.

3) ACTIVATED CARBON FILTER - The water is then passed through activated carbon filter to
remove organic impurities.

4) MICRON CARTRIDGE FILTER (MCF) - Water is then passed through a micron filter or a
series of such filters (0.1 – 0.5 u) for removal of fine particles.

5) DEMINERALISATION BY REVERSE OSMOSIS SYSTEM (R.O.) - Water from MCF goes

to R.O. System through High Pressure Pump. R.O. removes 90-95% of dissolved solids. The
finished water is passed into Storage Tank through SS/ inert pipe line.

6) OZONE GENERATOR WITH RE-CIRCUALTION - Finished water from R.O. system is

stored in S.S storage tank. The tank is provided with a Man Hole so that the tank can be cleaned.
This tank is used as ozone circulation tank. The ozone is passed to this tank for disinfection.

7) U.V. SYSTEM - Water from S.S. tank is passed through MCF to U.V. disinfection system,
where the bacteria are inactivated.

8) FILLING AND PACKING - Water is then filled in cleaned and rinsed containers.

9) VISUAL EXAMINATION - Containers are visually inspected for any leakage and suspended
matter against illuminated screen.

10) TESTING - The raw water is tested once in three months. Finished water is tested as per
scheme of testing prescribed by BIS.

55
 A TYPICAL PROCESS FLOW CHART

RAW WATER EXTRACTION THROUGH BORE WELL

↓
RAW WATER STORAGE
TESTING

CHLORINE DOSING
↓
FILTRATION THROUGH SAND BED
↓
FILTRATION THROUGH ACTIVATED CARBON BED
↓
MICRON CARTRIDGES FILTRATION
↓
FEEDING BY HIGH PRESSURE PUMP
↓ ANTISCALANT DOSING
REVERSE OSMOSIS
↓
RO OUTPUT OZONE INJECTION WITH
↓ RE-CIRCULATION
U.V. SYSTEM
↓
FINAL PRODUCT STORAGE

FILLING AND PACKING

↓
PRODUCT TESTING
↓
DESPATCH

56
 A TYPICAL CIP PROCESS

Sanitization and Sterilization is done daily before resuming production

SANITIZATION

1. Take sufficient quantity of soft water in CIP tank.

2. Add required quantity Sodium Hypochlorite solution in CIP tank containing soft water.
3. Now start CIP pump.
4. Let the chlorine solution go into tank through CIP line.
5. Solution will go from top through CIP volume which distributes solution in entire tank.
6. Check the available chlorine.
7. Chlorine (free) should be 10-15 PPM.
8. If percentage of chlorine is less then add more Sodium Hypochlorite solution till required strength
of chlorine is achieved in water.
9. Start feed pump and pass solution through sand filter, (bypassing carbon filter since it removes
chlorine), all micron filters, Ozone contact column etc. and filling machine.
10. Hold this solution at least for 30 minutes which can be extended to overnight.
11. Drain out the solution from the whole system.
12. Take fresh water and remove the chlorine of storage tank.
13. After removing chlorine traces from storage tank, fill with fresh bore well water.
14. Remove the chlorine traces from each points upto filling machine by flushing with fresh water.
15. Check for residual chlorine.
16. Do final washing with product water.

STERLIZATION

1. Produce soft water by softener

2. Generate steam by boiler using soft water.
3. Supply steam in storage tanks, bore well line and pipe lines upto filling machine.
4. Continue the steam supply in tanks till attains required temperature.
5. Continue the steam supply to filling machine till steam comes out from all rinsing and filling
nozzle of machines.
6. Stop steam supply and disconnect the hose pipe.
7. Rinse the whole system with product water.

57
 TYPICAL CLEANING AND WASHING SYSTEM OF RE-USABLE JARS

The process of cleaning and washing of re-usable jars is as follows:-

1. Check the jars for crack, contamination and foul odors. Reject jars not fit for re-use.

2. Wash the outside of jars thoroughly with detergent solution and normal water.

3. After outer cleaning, wash jars internally with food grade detergents (like iodine based) and then
thoroughly wash till free of last traces of detergent.

4. Send clean jars to filling station.

5. Rinse jars internally with product water, before final filling at filling station.

58
 ANNEX 6
(Clause 4.10)

CHECK LIST FOR RED FORM OF PACKAGED DRINKING WATER (IS 14543) and
NATURAL MINERAL WATER (IS 13428)

ITEM CHECK POINT DOCUMENT REMARKS

No. (Tick)
Address Same address given in 1 Verify in application. Plot Purchase/ Rent
Application Form, PIR, RF and 1 (a) etc. agreement or lease agreement etc.
Other Documents
Authorized Person Authority Letter (In case 2
application and other
documents are signed by person
other than Proprietor/Partner/
Director of the applicant)
Status of Unit Manufacturing status is clearly 3 SSI Certificate/Chartered Accountant/
stated as large/small scale in Certificate from any other agency.
order to give concession in
marking fee.
STI Acceptance of STI is for the 4 Should not be signed on blank proforma
latest version
Marking fee Acceptance of applicable 5 Should not be signed on blank proforma
Marking Fee with complete
details
Brand Name(s) Proforma CM/PF 307 6 Enclose copies as applicable, for each brand
Agreement with Brand Owner, 6 (a)
if applicable 6 (b) etc.
Test Reports Reports for Water cover all the 7 Reports of all samples to be attached, i.e.,
requirements for 7 (a) including those of failures, if any.
7(b)
Physical/ Chemical Tests 7 (c) etc. Pass/Fail to be clearly mentioned on each test
Microbiological Test report by Dealing officer for samples drawn
Pesticides Residues by BIS for test reports verified by him/her
Radio Active Residues
Code numbers and details of samples in TR
Packaging material report for and IR tally.
the relevant type, material and
capacity Test reports under Simplified should not be
older than 30 days
Approval of Approval of Competent 8(a)
Testing Authority for change of lab, if
applicable
Factory Testing in Permission of Competent 8 (b) Factory test report should be as per CL
lieu of I/T Authority proforma,
Manufacturing Plant machinery declaration 9 CM/PF 305 should be countersigned by IO on
Facilities including details for source and all pages.
storage of raw water
Testing Testing facilities including 10 CM/PF 306 should be countersigned by IO on

59
Facilities details of test method adopted all pages.
by the firm, wherever options
available

Consent Letter Firm’s request for permitting 11 (a) Permission should to be granted only for
for testing in testing at OSL, Consent from 11 (b) requirements having frequencies of test as
Outside Lab OSL for testing on behalf of 11 ( c) monthly & above
applicant,
Permission by the CA
Calibration of As a minimum, following Copies of calibration certificates to clearly
Instruments instruments shall be got indicate the validity status and traceability
calibrated: 12 (a)
Analytical Balance 12 (b) etc.
All Incubators
Quality Appointment letters of testing 13 (a) Testing personnel should be employed as full-
Control personnel time.
Personnel Qualification certificates of Verification of competence should be clearly
testing personnel recorded by IO.

Preliminary Preliminary Inspection Report 14(a) Report to clearly indicate availability of

Inspection infrastructure for manufacturing & testing of
Report Raw Material receipt details 14(b) product as declared by the applicant.
(for Old Procedure) Declarations made by the applicant on the
Manufacturing Process – 14( c) prescribed proforma should be verified and
indicating complete process, countersigned by the IO.
treatment for disinfection (for
each type of packing, if 14(d) Discrepancies, if observed during the
different) Preliminary Inspection, should have been
Process Flow Diagram 14(e) conveyed through D/V report and also
attached with the preliminary inspection
Layout Plan of Factory – report
clearly indicating locations of
raw water source & storage,
process equipment, plant 14(f)
machinery, Packing & Storage
Area, Change Room, Toilet etc. 14(g)

Report of testing of raw water

14(h)
Firm’s own testing of processed
water indicating conformity to
ISS 14 (i)

Reports of plastic containers 14 (j)

submitted by firm, as applicable
Any other document such as :
Test Results of samples tested
in factory (if not reported in
PIR)
Sample Labels, if available

60
Contact Report Visits other than Preliminary 15(a)
Inspection 15 (b) etc.

Verification Visit Report of verification 16 (a) Annex III or Annex IV to be used by IO. All
under Simplified Factory testing Report 16 (b) the declarations made by the applicants shall
Procedure be verified and countersigned.
Hygienic Complete assessment as per 17(a) Assessment report should be countersigned by
Conditions Annex B 17(b) IO.
Medical Examination of 17( c)
employees
Pest Control treatment (as
applicable)

Declarations by the Undertaking to intimate BIS 18

firm regarding shifting of Plant
Machinery/Test Equipment
19
Ownership of Plant
Machinery/Test Equipment
(if not covered under Doc. No. 20
9 & 10)

Affidavit on Stamp paper for 21

material offered for inspection
(for sample drawn from stock) 22

Indemnity Bond (for Blocking

of CM/L-No.)

Undertaking regarding
cancellation of licence in case
verification sample fails
Any Other Other documents, as relevant to 23 onwards
Documents the
Application
Red Form Should be complete in all Clear recommendations for scope w.r.t Type,
respect Material & Capacity of containers

Recommendations of Dealing Officer & Date

GL
Head

61
 CM/PF /PDW
AUG 2009
ANNEX 7
(Clause 5.2)
BUREAU OF INDIAN STANDARDS
REPORT OF PERIODIC INSPECTION
(. .. . . . . . . . . . . . inspection since the grant of licence/Renewal)

CM/L - IR No.. . . .
Valid upto: Date of writing IR . . . . . . .

1. a) Licensee

b)IS 14543:2004 Packaged Drinking Water (Other Than Packaged Natural Mineral Water)/
IS 13428:2005 Packaged Natural Mineral Water

Type, Material & Capacity of containers covered under licence

c) Other license(s) held CM/L . . . . .. . . . . IS Product

4 Special inspection charges, if applicable, with details of realization

3. Date(s) of inspection

4. Person(s) contacted

5. Change in Management, if any

6. Previous inspection

a) Date(s) b) Conducted by
c) Conclusion and Recommendations

d) Details of last 2 factory samples

Sl. No. Date of drawl Mode & Date Status of sample Pass/Fail
of sample of dispatch (whether report recd.) (if applicable)
----------------------------------------------------------------------------------------------------------------
1.
2.
---------------------------------------------------------------------------------------------------------------
7. ACTION ON ADVICE RENDERED IN PREVIOUS INSPECTION OR OTHERWISE ASKED FOR
WHILE GRANTING LICENCE /RENEWAL OF THE LICENCE
_______
REMARKS OF THE REVIEWING OFFICER ON PERFORMANCE OF LICENSEE KEEPING IN VIEW THE
PAST PERFORMANCE (ON IRS, TRS , GENERAL ETC)

SIGNATURE & DATE

62
 (2)
CM/L - ……………
8. Source of Raw Water

a) Own Bore well/Municipality/Other Source Supply (specify)

b) Whether source changed from declared earlier
c) If yes, compliance to STI
d) Whether records of testing maintained as per STI

9. Packaging Material (Jar/Bottle/Cup/Glass/ Caps/Closures/Pouch-Give details in each case)

a) Details of Receipt
Container Name of the Supplier Whether BIS Whether recd.with Whether tested
Certified test certificate in-house

Type Material Capacity

b) Whether packing is done in approved container(s)? If not, give details

c) Whether records being maintained in accordance with STI

10. PRODUCTION DETAILS

a) Whether Water being produced/packed at the time of inspection

b) Whether any change in the process of manufacturing & disinfection from that declared
earlier? If yes, give details (Disinfection of natural mineral water is not permitted)

c) Production Controls (Satisfactory/Unsatisfactory)

e) Production & supply since last periodic inspection (enclose details for completed
month)

i) Quantity produced
ii) Quantity marked
iii) Quantity unmarked and manner of disposal
iv) Reason for not marking
v) Parties supplied to (Give complete address):

63
 (3)
CM/L -………………
11. Storing, Packing and marking of BIS certified material
a) Material held in stock

b) Packing and marking on packages

c) At what stage marking is done

(After or before test results are known)

d) Any change in the marking procedure from approved one

e) Compliance to Labeling Prohibitions

12. TESTING ARRANGEMENTS & TESTING

a) Details of change(s) in Testing Personnel, if any

since previous inspection

b) Competence of new Testing Personnel

c) Are the frequencies of tests and records

testing being maintained satisfactorily
vis-à-vis the STI

d) Variation in factory test result Enclose Report in Annexure – 7A

e) Details of testing got done from Enclose Report in Annexure - 7B

outside laboratory

f) Details of failure reported, if any and

corrective actions taken for the same

g) Are all required instruments available and

in working order? If No, give details

h) Change/addition in testing facilities/arrangement

i) Details of calibration of Balance, Thermometers& pressure gauge

13 Testing in factory

Description of the sample (Type, Material, Capacity of containers and B.No./Mfg.Date):

Sl.No.Requirements Tested Value Obtained Value Recorded Remark

64
 (4)
CM/L………………….
14. Samples for Independent Tests
a) From where sampled (Stock/production line)?

b) Details of sample (Batch/Lot No., Date of Mfg.

Shelf-Life and Type, Material and Capacity

c) Test record of the batch from which sample is drawn Report in Annexure - 7A

d) Give details of packing, labeling, coding, sealing of the sample

e) Mode of dispatch and laboratory to which sample will be tested

f) Details of the counter sample left with the firm

15. HYGIENIC CONDITIONS

a) Availability of responsible/designated hygiene control incharge

b) Overall compliance to Annex B of IS 13428/IS 14543 Satisfactory/Unsatisfactory

as verified as per the check-list attached

16. CONCLUSION AND RECOMMENDATIONS

a) Assessment of performance since last inspection Satisfactory /Unsatisfactory

b) If operated unsatisfactorily, give reasons

(Also indicate whether the discrepancies were
conveyed to the licensee through D/V Report, if so enclose copy)

c) Any discussion with the firm for difficulties,

in production, testing, operation of Scheme and
actions proposed, if any for the difficulties observed
d) Recommendation for action to be taken
f) Any other observation/comments for better
appraisal of the report

Signature:
No. of Encl.: Inspected by:
(Name)
Designation:
Station: Date:

65
 CM/L …………….
ANEXURE – 7A
ASSESSMENT OF COMPLIANCE TO IS 13428 FOR PNMW/IS 14543 FOR PDW

Sl. REQUIREMENT LIMIT VARIATIONS BATCH DRAWN

No. PDW PNMW FROM FOR IT
RECORDS
FOUR HOURLY
1. Description To comply
2. Colour 2 Max 2 Max
3. Odour Agreeable Agreeable
4. Taste Agreeable Agreeable
5. Turbidity 2 NTU, 2 NTU,
Max Max
6. pH 6.5 to 8.5 6.5 to 8.5
EACH CONTROL UNIT
1. Total Dissolved Solids 500 mg/l, 150–700
Max mg/l, Max
2. Chlorides 200 mg/l, 200 mg/l,
Max Max
3. Sulphate 200 mg/l, 200 mg/l,
Max Max
4. Alkalinity 200 mg/l, 75–400
Max mg/l
5. Residual Free Chlorine 0.2 --
6. Escherichia coli Absent Absent
7. Coliform bacteria Absent Absent
8. Sulphite reducing Absent Absent
anaerobes
9. Pseudomonas Absent Absent
aeruginosa
10. Aerobic Microbial a) 20/ ml, --
Count Max at
0
37 C &
b) 100/ml,
Max at 20-
220C
11. Yeast & Mould Count Absent Absent
ONCE IN A WEEK
1. Barium 1 mg/l, 1 mg/l,
Max Max
2. Copper 0.05 mg/l, 1 mg/l,
Max Max
3. Iron 0.1 mg/l, 0.1 mg/l,
Max Max
66
4. Manganese 0.1 mg/l, 2.0 mg/l,
Max Max
5. Nitrate 45 mg/l, 50 mg/l,
Max Max
6. Nitrite 0.02 mg/l, 0.02 mg/l,
max Max
7. Zinc 5 mg/l, 5 mg/l,
Max Max
8. Aluminium 0.03 mg/l, 0.03 mg/l,
Max Max
9. Calcium 75 mg/l, 100 mg/l,
Max Max
10. Magnesium 30 mg/l, 50 mg/l,
Max Max
11. Anionic Surf. Act. 0.2 mg/l, Not
Agents Max detectable
12 Sulphide 0.05mg/l 0.05mg/l
Max Max

67
 CM/L………………..
ANNEX - 7B
DETAILS OF TESTING GOT DONE FROM OUTSIDE LABORATORY
(PROGRESS SINCE LAST PERIODIC INSPECTION)

Sl.No YEAR MONTHLY, 3 MONTHLY, 6 MONTHLY, YEARLY,

B.NO./TR NO. B.NO./TR NO. B.NO./TR NO. B.NO./TR NO.
MONTH (RESULT/SENT) (RESULT/SENT) (RESULT/ SENT) (RESULT/SENT)
1 JAN

2 FEB

3 MAR
4 APR
5 MAY
6 JUN
7 JUL
8 AUG
9 SEP
10 OCT
11 NOV
12 DEC

TWO YEARLY TEST:

68
 ANNEX 8
(Clause 5.2)
HYGIENE CHECK LIST
( VERIFICATION DURING PERIODIC INSPECTION/ SURVEILLANCE VISIT OF
PACKAGED DRINKING WATER / PACKAGED NATURAL MINERAL WATER AT BIS
LICENCED UNIT)
CM/L- DATE OF VISIT:

NAME OF THE UNIT:

Particulars Requirements Observ Remarks, if any

ation
Extraction/Collection The source of extraction is well Yes/No
protected from Contamination and
unauthorized access
Raw Water Storage Storage tank for raw water is clean Yes/No
and cleaning schedule is being
followed.
Processing Area - Processing area is clean and Yes/No
adequately closed.
- Adequate ventilation and lighting Yes/No
facilities available and working
- Wire mesh/glass provided on Yes/No
windows
- Walls and ceiling are well painted Yes/No
and clean.
- Flooring is smooth, sloped, clean Yes/No
and free from cervices.
- Freedom from insects, rodent and Yes/No
birds, animals etc.
- Fly-catchers provided. Yes/No
- Not being used for storage Yes/No
purposes.
- Drains are clean and well covered. Yes/No
- Doors are self closing/close fitting Yes/No
type with air-curtains
Hygienic Facilities - No over flow/ dripping from Yes/No
processing vessels.
- Cleaning schedule of equipment is Yes/No
adequate and is being followed.
- Proper disinfection of containers Yes/No
and caps is being ensured.
- Washing and disinfection of
reusable jars is being done Yes/No
adequately and absence of

69
 residual cleaning chemicals
ensured.
- Changing facilities are clean and Yes/No
not being used as store.
- Toilets are clean and away from Yes/No
processing area.
- Protective clothing being used by Yes/No
workers coming in contact with the
product.
- Medical examination of workers is Yes/No
being done periodically and
affected personnel are not allowed to
work.
- Adequate hand washing facilities
are available and notices to this Yes/No
effect are displayed.
- Personnel are being trained in
food handling, processing and Yes/No
personal hygienic.
Raw Material - The raw material including bottles, Yes/No
caps, etc. are properly stored and
free from probable contamination.
- TC of R/M is available Yes/No
consignment wise.
Finished Product - Finished product pipeline and Yes/No
storage tank is of inert material and
is clean and free from corrosion.
- Cleaning schedule being followed Yes/No
and supervised by identified
personnel.
- Inspection screen is provided and Yes/No
is well lit.
Storage of finished - The packed material is stored Yes/No
product adequately under hygienic
conditions, free from chances of
contamination.

OVERALL ASSESSMENT OF HYGIENIC CONDITIONS: SATIS./NOT SATIS.

Signature of I.O._______________
Name:________________________
Date:___________________

70
 ANNEX – 9

LIST OF TEST FACILITIES

A- ORGANOLEPTIC AND PHYSICAL REQUIREMENTS

Sl. Tests Clause Ref. of Referred Test Equipment/Apparatus Chemicals/Reagents

No. IS 14543:2004 Method of Test
or & (6)
IS 13428:2005 Limit of
Detection
(1) (2) (3) (4) (5)
1. Colour 5.2, Sl No. i) IS 3025 (P 4):1983  Nessler cylinders,50 ml  Potassium chloroplatinate
of Table 1 with Am. 1  Centrifuge or filter assembly, functional pore  Cobaltous chloride, crystalline
size 0.45µm  Conc. Hydrochloric acid
i) Platinum cobalt  Distilled water
(Visual comparison
method)

ii) Spectrophoto-  Spectrophotometer,400-700 nm with 10 mm

absorption cell ● Conc. Sulphuric acid
metric method  Filteration system consisting of filteration flask
with side tubes ● Sodium hydroxide
 crucible holder
 Micrometallic filter crucible, pore 40 µm
 Calcined filter aid (Celite 505 or equivalent
 Vacuum system
 Refrigerator (recommended)
 pH meter
 Centrifuge

71
2. Odour 5.2, Sl No. ii) of IS 3025 (P 5):1983 Wide mouth glass stoppered bottles (approx. 1 lit. ● Odour free distilled water (or distilled water
Table 1 capacity) and column of granulated activated carbon)

● Hydrochloric acid

3. Taste 5.2, Sl No. iii) IS 3025 (P 8):1984  Breaker (50 ml)  Taste and Odour free water 2000 mg/l
of Table 1  Water bath solution of sodium chloride
 Thermometer
4. Turbidity 5.2, Sl No. iv) IS 3025 (P 10):  Sample tubes  Distilled water
of Table 1 1984  Turbidimeter  Hexamethylene Tetramine
 Volumetric flasks (100 ml)  Hydrazine sulphate
 Membrane filter with pore size not more than
0.45 µm
5. Total 5.2,Sl No. v) of IS 3025 (P 16):  Filter:
dissolved Table 1 1983 with Am. 1  Filtering Assembly (suitable for type of filter
solids selected)
 Drying oven (180 ± 2˚C)
 Desiccator
 Analytical balance (200 g capacity, l.c. 0.1
mg)
 Pipettes
 Evaporating dish
 Magnetic stirrer, recommended

72
pH 5.2,Sl No. vi) of IS 3025 (P 11):  pH meter – with glass and reference electrode  Standard pH Buffer solutions/tablets
Table 1 1983 (saturated calomel) l.c 0.1 (Minimum two different values)
 Magnetic stirrer with polytetrafluoro ethylene OR
coated stirring bar
 Thermometer (l.c. 0.5°C)  Distilled water
i) Electrometric  Beakers  Borax (for Borax buffer)
method  Potassium dihydrogen phosphate,
Sodium hydrogen phosphate and oven
(for phosphate buffer)
 Potassium hydrogen tartarate (for Tartarate
buffer)
 Potassium hydrogen phthalate (for Phthalate
buffer)
 Potassium tetraoxalate dihydrate (for
Calcium hydroxide buffer)
 Calcium Carbonate
Platinum dish, Muffle furnace, Hot Plate, Fritted
glass filter of medium porosity, polyethylene
bottle, Suction pump & fritted glass funnel (for
Tetra oxalate buffer)

 Methyl orange, methyl red, bromothymol

blue, phenolphthalein and alcohol (66%) (for
ii) Colorimetric universal indicator)
Method  Thymol blue indicator (acid range)
 Hard glass tubes
 Bromophenol blue indicator
 Bromocresol green indicator
 Methyl red indicator
 Bromocresol purple indicator
 Bromothymol blue indicator
 Phenol Red indicator
 Cresol Red indicator
 Thymol Blue (alkali range) indicator
 Thymolphthalein indicator
 Thymol violet indicator
 Different buffer solutions of known pH

73
 B - CHEMICAL REQUIREMENTS

Sl. Tests Clause Ref. Referred Method of Test Equipment/Apparatus* Chemicals/Reagents

No. of Test
IS &
14543:2004 Limit of Detection
or
IS
13428:2005
(1) (2) (3) (4) (5) (6)
1. Barium 5.2, Sl. No i) i) Annex F of IS  Filter paper and filtration assembly  Ammonium Dichromate
of Table 2 13428:2005  Hot plate/gas burner  Ammonium Acetate
 Ammonium Hydroxide
 Potassium Iodide
 Sodium Thiosulphate(0.1N)
 Hydrochloric Acid
 Ammonium Chloride
 Starch indicator

 Atomic Absorption Spectrophotometer and  Metal free water

ii) IS 15302:2003 Associated equipment (Burner, Readout  Hydrochloric Acid
mechanism, lamp for Barium, Pressure  Nitric Acid
Reducing valves and vents)
 Sulphuric Acid
 Nitrous oxide burner head
 Hydroflouric Acid
 T-junction valve or other switching valve
 Potassium Chloride
Air
 Standard barium solution 100µg/ml
Acetylene Gas
(Barium chloride, oven, hydrochloric
Nitrous oxide gas acid)

74
 iii) IS 3025 (P 2)  Induction Coupled Plasma-Atomic Emission
Spectrometer  Nitric Acid
:2004  Sample Bottles  Hydrogen Peroxide
 Glasswares  Sulphuric Acid
 Acid Dispensers  Hydrochloric acid
 Membrane Filtration Equipment and Filters  Ammonium Sulfate
(0.45µ)  Stock Solution of Barium
 Hot Plate
 Argon Gas

2. Copper 5.2, Sl No. ii) i) IS 3025 (P 42): 1992

of Table 2 with Am 1

a) Neocuproine Method
Detection range 0.05 to
5.0mg/l
Spectrophotometer & 1cm cell  Ammonium Hydroxide
Hot plate  Chloroform, AR Grade
Separating funnels (125 ml)  Hydrochloric acid, Conc.
Conical flasks  Hydroxylamine Hydrochloride
 Isopropyl Alcohol
 Neocuproine
 Double Distilled water
 Nitric Acid, Conc.
 Sulphuric Acid, Conc.
 Hydrated Sodium Citrate
 Stock copper (II) solution 200µg/ml
(Pure Copper Metal, hot plate)
 Hydrogen Peroxide

b) Atomic Abso- rption  Atomic Absorption Spectro- photometer  Hydrochloric Acid, Conc.
Method (Direct) with  Nitric Acid, Conc.
air-acetylene flame & Copper Hollow  Dilute Sulphuric Acid
Cathode lamp  Stock copper (II) solution – 1.0mg/ml
(Pure Copper metal & hot plate)
Detection range 0.02 to
5.0mg/l

75
c) Atomic Absorption  Hydrochloric Acid, Conc.
Method (Chelation  Atomic Absorption Spectrophotometer with  Nitric Acid, Conc.
Extraction) air-acetyleneflame  Pyrrolidine
 Copper Hollow Cathode Lamp  Dithiocarbamic acid
 Separating Funnel  Methyl Isobutyl Ketone, AR grade
 Volumetric Flasks  Carbon Disulphide
Detection range 0.002  Distillation Assembly  Sodium Hydroxide
to 0.5 mg/l  Distilled water
 Water Standard MIBK
 Bromophenol Blue
 Ethanol or Isopropanol
 Stock copper (II) solution – 1.0mg/ml
(Pure Copper metal & hot plate)

 Hydrochloric Acid Conc. (Spectro

d) Differential  Polarograph capable of Performing differential Grade)
Pulse Anodic pulse work  Nitric Acid-Conc. (Spectro Grade)
Stripping  Hanging Mercury Drop electrode  Sulphuric Acid Conc.
Voltametry  Platinum Counter Electrode  Pure Copper Metal
 Saturated Calomel Reference Electrode  Granular Zinc
 Magnetic Stirrer Control unit with Stirring Bar  Mercury
Detection range 0.01 to  Scrubber Assembly
0.1mg/l  Whatman Filter Paper No. 40
 Nitrogen Gas

ii) IS 3025 (P 2)  Induction Coupled Plasma-Atomic Emission  Nitric Acid

Spectrometer  Hydrogen Peroxide
:2004  Sample Bottles  Sulphuric Acid
 Glasswares  Hydrochloric acid
 Acid Dispensers  Ammonium Sulfate
 Membrane Filtration Equipment and Filters  Stock Solution of Copper
(0.45µ)
 Hot Plate
 Argon Gas

76
3. Iron 5.2, Sl. No i) IS 3025 (P 53) :2003
iii) of Table 2
a) 1,10 Phenanthroline
Method
i) Detection range
0.075 to 0.5mg/l
Amalgamated Zinc (Granular Zinc and
Spectrophotometer Mercury)
Std. volumetric glass wares
Hot Plate  Ammonium Meta Vanadate
Fuming Hood  Distilled water
0.45µ m Membrane Filter with  Hydrochloric Acid-Conc. (Containing less
Filtration Assembly than 0.00005% iron)

Hydroxylamine Hydrochloride
Ammonium Acetate
ii)This requirement is Glacial Acetic Acid
not applicable for  Sodium Acetate
Packaged Natural 1,10 Phenanthroline Monohydrate
Mineral Water  Stock Iron Solution 1ml=200µg of Fe
(Conc. Sulphuric Acid, Ferrous
Ammonium Sulphate, Potasssium
Permanganate)
Std. Iron Solution (1.0 ml=1.0µg of Iron)
 Di-isopropyl Ether

b) Atomic Absorption  Distilled water

Method (DIRECT)  Atomic Absorption Spectrophotometer
 Air Acetylene Flame
Detection range 0.1 to Iron Hollow Cathode Lamp or
10 mg/l Electrodeless discharge lamp for use at
248.3nm
 Hydrochloric Acid, Conc.
 Nitric Acid, Conc.
 Sulphuric Acid, Conc.
 Calcium Chloride Solution (Calcium
 Carbonate, Hydrochloric acid)

 Volumetric Flasks  Stock Iron Solution (1.0 ml=100µg of Fe)

(Pure iron wire, Hydrochloric acid Nitric
Acid)

77
 ii) IS 15303:2003  Metal free water
 Hydrochloric Acid, Conc.
Electrothermal Atomic  Atomic Absorption Spectrometer  Nitric Acid, Conc.
Absorption  Hollow Cathode lamp for Iron  Matrix Modifier stock solutions
Spectrometric Method  Graphite Furnace  (Magnesium Nitrate, Nickel Nitrate,
 Readout Mechanism Phosphoric Acid, Palladium Nitrate &
 Sample Dispenser Citric Acid)
 Vent for fumes  Stock iron Solution – 100µg/ml (Iron
Minimum detection  Cooling device wire)
limit 0.001mg/l  Membrane Filter, 0.45µm  Sodium hydroxide 10N
 Chelating resin

iii) IS 3025 (P 2):2004  Induction Coupled Plasma-Atomic Emission  Nitric Acid

Spectrometer  Hydrogen Peroxide
 Sample Bottles  Sulphuric Acid
 Glasswares  Hydrochloric acid
 Acid Dispensers  Ammonium Sulfate
 Membrane Filtration Equipment and Filters  Stock Solution of Iron
(0.45µ)
 Hot Plate
 Argon Gas

4. Manganese 5.2, Sl. No. i) IS 3025:2006 Part 59  Nessler’s Tubes  Sulphuric Acid
iv), Table 2  Beakers  Hydrogen Peroxide (30%)
a) Periodate  Hot Plate  Nitric Acid, Conc.
Colorimetric Method  Volumetric flask  Stabilized Distilled Water OR
 Pipettes
 Distillation Assembly, OR
Detection limit up  Conical Flasks
Distilled water,
to 0.2mg/l  Burette
 Potassium Permanganate and
 Dil Sulphuric Acid
 Phosphoric Acid (sp. Gr. 1.75)
 Potassium Periodate
 Std. Manganese Solution
(1ml=0.02 mg of

78
 Mn) (Standard 0.1 N Potassium
Permanganate solution, saturated
solution of sulphur dioxide)

 Fluoride Free Water

b) Formaldoxime  Potassium Peroxodisulphate or Sodium
Spectrometric Method  Spectrophotometer Peroxodisulphate
 Glass Bottle  EDTA Tetrasodium Salt, Solution, c(EDTA)
Detection limit  Autoclave  Sodium Hydroxide
between 0.01mg/l to 5  Hydroxylammonium Chloride
mg/l  Formaldehyde
 Ammonia Solution
 Ammonium Iron (II) Sulphate Hexahydrate
Solution
 Sulphuric Acid, conc.
 Manganese Monohydrate (for Standard Mn
Solution)

 Induction Coupled Plasma-Atomic Emission  Nitric Acid

Spectrometer  Hydrogen Peroxide
 Sample Bottles  Sulphuric Acid
ii) IS 3025 (P 2):2004
 Glasswares  Hydrochloric acid
 Acid Dispensers  Ammonium Sulfate
 Membrane Filtration Equipment and Filters  Stock Solution of Iron
(0.45µ)
 Hot Plate
 Argon Gas

5. Nitrate (as 5.2, Sl. No. IS 3025 (Part 34):1988  Reduction Column  Distilled water
NO3) v) of Table 2  Colorimeter OR  Nitrate free water
 Spectrophotometer OR  Cadmium granules (40 – 60 mesh)
 Filter photometer  Hydrochloric Acid (6N)
i) Cadmium Reduction  Glass wool  Copper Sulphate Solution
Method  0.45 µ m pore diameter membrane filter  Sulphanilamide
 Refrigerator  Conc. Hydrochloric Acid
 N-(1-napthyl))-Ethylenediamine

79
 dihydrochloride (NED) Dihydrochloride)
 Ammonium Chloride
Detection limit Disodium Ethylene diamine tetra acetate
maximum 0.1 mg/l Ammonia Solution
 Copper sulphate Solution – 2%
 Stock nitrate solution – 100µg/ml
(Potassium Nitrate & Chloroform)

 Chloroform
 Stock nitrite solution - 100µg/ml
(Potassium Nitrite & Chloroform)

 Nitrite free water

ii) Chromotropic Acid Nitrate free water

Method Spectrophotometer
Stock Nitrate Solution - 100µg/ml
 Standard laboratory glasswares (Potassium Nitrate, Chloroform)

 Standard Nitrate solution – 10.0µg/ml

Detection range 0.1 to  Sulphite Urea Reagent
5.0mg/l (Urea & Anhydrous sodium Sulphite)

 Antimony reagent (Antimony metal,

Conc. Sulphuric acid)

 Chromotropic Acid Reagent (Purified

chromotropic Acid crystals, Conc.
Sulphuric Acid)
 Sulphuric Acid, Conc. Nitrate free

iii) Devarda’s Alloy Ammonia Free Water

Distillation Assembly (Kjeldahl
Reduction Method  Borate Buffer Solution (0.1N Sodium
Assembly) Hydroxide, 0.025M Sodium Tetraborate)
Detection limit  Sodium Hydroxide – 6 N
minimum 2 mg/l  Devarda’s Alloy – 20 mesh with less than
 Measuring Scoop
 Spectrophotometer

80
 0.005 percent Nitrogen

 Mixed indicator Solution (Methyl Red

indicator, Ethyl alcohol/Isopropyl alcohol,
Methylene Blue)

 Indicating Boric Acid Solution

(Hydroboric Acid, mixed indicator
solution)
 Std. Sulphuric Acid Titrant - 0.02 N
 Nessler’s Reagent (Mercuric Iodide,
Potassium Iodine. Sodium Hydroxide)
 Stock Ammonia Solution -1.22mg
ammonia/ ml (Anhydrous Ammonium
Chloride)
 Standard Ammonia Solution
6. Nitrite 5.2, Sl. No. IS 3025(P 34) :1988 Spectrophotometer / Photometer  Nitrite Free water (Distilled water,
vi) of Table OR Potassium Permanganate, Barium
2 Hydroxide/Calcium Hydroxide Conc.
 Nessler’s cylinders method Sulphuric Acid, Manganese Sulphate)

 Nessler’s Tubes  Sulphanilamide Reagent

 0.45 µm Membrane Filter
 Distillation Assembly (borosilicate)
 NED Dihydrochloride
 Hydrochloric Acid
 Sodium Oxalate – 0.05 N.
 Ferrous Ammonium Sulphate – 0.05N
(Ferrous Ammonium Sulphate, Conc.
Sulphuric Acid, Std. Dichromate solution)
 Stock Nitrite Solution - 250µg of
nitrogen/ml (Sodium Nitrite, Chloroform,
Sodium Oxalate, Std., Potassium
Permanganate solution)
 Intermediate Nitrite Solution – 50.0µg/ml
Standard Nitrite Solution – 0.500µg/ml

81
7. Flouride 5.2, Sl. No. Clause 23 of  Nessler Tubes (100ml)  Sodium Thiosulphate Solution (0.1 N)
vii) of Table IS 3025:1964  Distillation Apparatus  Standard Sodium Fluoride Solution (1ml =
2  Refrigerator (Recommended) 0.01 mg F)
i) Zirconium alizarin  Heating mantle  Zirconium Oxychloride OR Zirconium
Method Oxynitrate
 Alizarin Sodium Monosulphonate (Alizarin
S)
 Conc. Hydrochloric Acid
Detection range  Conc. Sulphuric Acid
 Silver Sulphate
0.05 to 1.0 mg/l  Perchloric Acid
 Phenolphthalein Indicator
 Sodium Hydroxide Solution
ii) Electro Chemical Millivolt Meter Sodium Hydroxide- 5 M
Probe Method
Fluoride Ion – Selective Electrode Total Ionic Strength Adjustment Buffer
(TISAB)-[Sodium Chloride, Glacial Acetic Acid,
Reference Electrode – Either a calomel electrode, Sodium Hydroxide, CDTA( trans -1,2-
Detection range filled with saturated Potassium Chloride (KCl) diaminocyclohexane – N,N,N’,N’ tetra acetic
Solution or a Silver / Silver Chloride Electrode acid)]
0.2mg to 2.0 g/l
easuring Cells – 100ml(Polypropylene fitted Fluoride, Stock Solution, 1000mg/1 (Sodium
with thermostated jacket ) Fluoride )

Water Bath

agnatic Stirrer with a

polytetrafluoroethylene(PTFE)

Polyethylene Beaker
Note :
pH meter
Purity of the reagent – Unless specified
Standard Volumetric Glasswares otherwise, only pure chemicals & Fluoride free
distilled water shall be used in tests.
Desiccator

82
 Screw Capped Polyethylene Container

Plastic Bottle 

8. Zinc 5.2, Sl. No. IS 3025 (P 49): 1994  Spectrophotometer (620 nm with 1cm cells)  Sodium Hydroxide
viii) of Table with Am 1  Potassium Cyanide
2  Cyclohexanone
 Distt. Water
 Zincon
i) Zincon Method  Methanol
 Sodium Ascorbate
 Borate Buffer Solution (Sodium
Hydroxide, Potassium Chloride, Boric
Detection range 0.02 to Acid)
5 mg/l  Hydrochloric Acid, Conc.
 Zinc Sulphate

 Atomic Absorption Spectrophotometer with

ii) Atomic Absorption Air-Acetylene Flame  Hydrochloric Acid, Conc.
Method (Direct)  Hollow Cathode Lamp  Nitric Acid, conc.
Or Electrodeless discharge lamp  Stock Zinc Solution – 1.0mg/ml (Zinc
Granules/Zinc Oxide)

Detection range 0.01 to

2.0mg/l

iii)Atomic Absorption  Atomic Absorption Spectrophotometer with Hydrochloric Acid, Conc.

Method (Chelation – Air-Acetylene Flame Nitric Acid, Conc.
Extraction)  Hollow Cathode Lamp  Pyrrolidine Dithio Carbamic Acid -
Chloroform Reagent (Pyrrolidine,
Detection range 0.001 Chloroform, Carbon disulphide)
 Sodium Hydroxide
to 0.2mg/l
 Chloroform

83
  Bromophenol Blue Indicator
(Bromophenol Blue, Ethanol or
Isopropanol)
 Stock Zinc (II) Solution- 1.0 mg/ml (Zinc
Granules or Zinc Oxide, Nitric Acid)

iv) Differential Pulse

Anodic Stripping  Hydrochloric Acid, Conc.
Voltammetry  Polarographic Instrumentation  Nitric Acid, Conc
(DPASV)Method Capable of Performing Differential  Stock Zinc Solution -1.0mg/ml
Pulse Work  Amalgamated Zinc (Granular Zinc, Conc.
Detection range 0.001  Hanging Mercury Drop Electrode Hydrochloric Acid, Mercury)
to 0.1mg/l  Platinum Counter Electrode  Purified Nitrogen (Ammonium Meta
 Saturated Calomel Reference Vanadate, Scrubber, Amalgamated Zinc,
Electrode Nitrogen Gas)
 Magnetic Stirrer
9. Silver 5.2, Sl. No. Annex J of IS Atomic Absorption Spectrophotometer  Deionised Distilled Water (Ion Exchange
ix) of Table 2 13428:2005 with Oxidizing Air Acetylene Flame Column & Distilled Water)
 Nitric Acid – Redistilled
 Hydrochloric Acid – Redistilled
 Silver Std. Solution (Silver Nitrate)
 Lanthanum Chloride
 Lanthanum Stock Solution (Lanthanum
Oxide, Hydrochloric Acid)
 Ammonium Pyrrolidine Dithiocarbamate
solution)
 Methyl isobutyl ketone

84
10. Aluminium 5.2, Sl. No. i) IS 3025(P 55): 2003
x) of Table 2
a) Eriochrome Cyanine Spectrophotometer (535 nm with 1cm Cells)  Sulphuric Acid – 0.02 N and 6 N
R Method  pH Meter  Ascorbic Acid Solution
 Standard Volumetric Glasswares  Buffer Solution (Sodium Acetate & 1 N
Acetic Acid)
 Acetic Acid Solution – 1:1 and 1 N
i) Detection range  Sodium Hydroxide Solution – 0.1 N and
0.02 to 0.3mg/l; 1N
 Stock Eriochrome Cyanine R Dye Solution
ii) This requirement is  Stock Aluminium Solution – 500 µg/l
not applicable for (Aluminium Potassium Sulphate)
Packaged Natural  Methyl Orange Indicator Solution
Mineral Water

b) Atomic Absorption  Atomic Absorption Spectrophotometer with  Hydrochloric Acid, Conc.

Nitrous Oxide – Acetylene Flame and  Nitric Acid, Conc.
Method (Direct)
Hollow-Cathode Lamp  Potassium Chloride Solution
 Standard Volumetric Glasswares  Stock Aluminium Solution - 500 µg/l
(Aluminium Potassium Sulphate)
Detection range 5 to
100mg/l

ii) IS 15302:2003 Direct  Atomic Absorption Spectrometer

Nitrous Oxide –  Metal Free Meter
 Burner  Hydrochloric Acid – 1 N
Acetylene Flame  Read Out Mechanism  Nitric Acid, Conc.
Atomic Absorption  Lamp (Hollow Cathode or EDL)  Sulphuric Acid
Spectrometry  Pressure Reducing Valves  Hydrofluoric Acid – 1 N
 Vent  Potassium Chloride
Detection limit 0.1mg/l  Nitrous Oxide Burner Head  Aluminium Nitrate
 T-Junction Valve or Other Switching Valve  Standard Aluminium Solution - 100 µg/l
 Air (Compressor or Bottled Gas) (Aluminium Metal)
 Acetylene, Standard Commercial Grade
 Nitrous Oxide Gas

85
11. Chloride 5.2, Sl. No IS 3025 (P32): 1988
.xi) of Table
2 i) Argentometric  Erlenmeyer Flask (250ml)  Potassium Chromate Indicator Solution
Method  Burette (Potassium Chromate, Silver Nitrate)
 Standard Silver Nitrate Solution – 0.01 N
(silver nitrate, sodium chloride)
 Standard Sodium Chloride Solution – 0.01
N (Sodium Chloride)
 Aluminium Hydroxide Suspension
(Aluminium Potassium Sulphate or
Aluminium Ammonium Sulphate, Conc
Ammonium Hydroxide)
 Phenolphthalein Indicator Solution
 Sodium Hydroxide – 1N
 Sulphuric Acid – 1N
 Hydrogen Peroxide – 30%

 Erlenmeyer Flask (250 ml)  Standard Sodium Chloride Solution,

ii) Mercuric Nitrate  Microburette (5 ml with l.c. 0.01ml) 0.01N
Method  Refrigerator  Nitric Acid, 0.1N
 pH meter  Sodium Hydroxide, 0.1N
 Indicator – Acidifier Reagent (S-
Diphenyl- carbazone, Conc. Nitric Acid,
Xylene Cyanol FF, Ethyl Alcohol or
Isopropyl Alcohol)
 Standard Mercuric Nitrate Solution, 0.01N
(Mercuric Nitrate, Conc. Nitric Acid,
Sodium Bicarbonate, Std. Sodium
Chloride Solution)
 Mixed Indicator Reagent
(Diphenylcarbazone, Bromo Phenol Blue,
Ethyl Alcohol or Isopropyl Alcohol)
 Standard Mercuric Nitrate Solution – 0.1N
 Glass and Silver- Silver Chloride Electrodes
iii) Potentiometric  Electronic Voltmeter  Standard Sodium Chloride Solution
Method  Mechanical Stirrer (0.01N)
 Nitric Acid-Conc

86
  Standard Silver Nitrate Solution (0.01N)
 Pretreatment Reagent (Sulphuric Acid,
Hydrogen Peroxide, Sodium Hydroxide –
1N)

iv) Automated  Automated Analytical Equipment  Stock Mercuric Thiocyanate Solution

Ferricyanide Method  Filters (480nm) (Mercuric Thiocynate, Methanol)
 Stock Ferric Nitrate Solution (Ferric
Nitrate, Conc. Nitric Acid)
 Colour Reagent (Poly oxy Ethylene 23
Lauryl Ether)
 Sodium Chloride
12 Selenium 5.2, Sl. No. i) IS 3025 (P56): 2003
xii) of Table
2

a)Spectrophotometric  Spectrophotometer (480nm,light path of 1  Stock Selenium Solution – 1.0mg/ml

Method cm (Sodium Selenite, Hydrochloric Acid)
 Volumetric Glasswares  Hydrochloric Acid – 0.1N
(Diamino naphthalene  Separating Funnel (250ml) Preferably  Ammonium Hydroxide,1:1Cyclohexane
method) Flourocarbon Stopcock  2,3 – Diaminonaphthalene (DAN)
 Water Bath – Thermostatically Controlled  Hydroxylamine Hydrochloride
Detection limit  pH Meter  Sodium Salt of EDTA
minimum 0.01mg/l  Centrifuge  Amberlite XAD -8 or Equivalent Resin
 Centrifuge Bottles with Flourocarbon Screw  Hydrochloric Acid, Conc
Cap  Potassium Hydroxide

b) Atomic Absorption  Nitric Acid

Spectrometric Method  Atomic Absorption Spectrometer ( 196.0  Sulphuric Acid
(Hydride Technique) nm) Fitted with Hydride System and Hollow  Hydrochloric Acid
Cathode Lamp/Electrodeless Discharge
 Hydrogen Peroxide
Lamp
 Sodium Hydroxide
 Gas (Argon or Nitrogen)
 Sodium Tetrahydro borate
 Glasswares Decomposition Apparatus
 Selenium Stock Solution (1mg/ml)
(Round Bottom Flask, Reflux Condenser,
(Selenium Dioxide)
Condensate Reservoir)

87
  Atomic Absorption Spectrometer  Metal Free Water
ii) IS 15303:2003  monochromator or filter and adjustable slit  Hydrochloric Acid, Conc
Electrothermal Atomic  Hollow Cathode Lamp or Electrodeless  Nitric Acid, Conc
Absorption Discharge Lamp  Matrix modifier Stock Solutions
Spectrometric Method  Graphite Furnace (Magnesium Nitrate, Nickel Nitrate,
 Photoelectric Detector Phosphoric Acid, Palladium Nitrate, Citric
Detection limit  Readout Mechanism Acid)
minimum 0.002mg/l  Sample Dispenser  Stock Metal Solution – 1mg/ml (Sodium
 Vent for Fumes Selenite)
 Cooling Device  Chelating Resin – 100 to 200 mesh
 Membrane Filter Apparatus (0.45 µ m)
Argon Gas

13 Sulphate 5.2, Sl. No. IS 3025 (P24): 1986

xiii) of Table
2 i)Gravimetric Method  Steam Bath  Methyl Red Indicator
 Drying Oven (thermostatically controlled)  Hydrochloric Acid
Detection limit more  Muffle Furnace  Barium Chloride
than 10mg/l  Desiccator  Silver Nitrate
 Analytical Balance (l.c.0.1mg)  Nitric Acid
 Filter Paper (Preferably Whatman No.42)  Ion Exchange Resin (Amberlite IR-120 or
 Silica or Porcelain Crucible (max pore size Equivalent)
of 5 microns)
 Ion Exchange Column
 Filter (0.45 µ m)
 Platinum Dish

ii) Thorin Method  White Porcelain Basin  Ethyl Alcohol

 Burette  Ammonium Hydroxide (Ammonia-Conc
Detection range 5 to and Distilled Water)
 Ion Exchange Column
150mg/l  Filter – 0.45µm  Hydrochloric Acid
 Thorin (2,2 – Hydroxy – 3,6 – Disulpho –
1 – Naphthylazo Benzene Arsenic Acid)

88
  Ion Exchange Resin (Amberlite
IR-120 or Equivalent)
 Stock Sulphate Solution – 100 mg/l
(Anhydrous Sodium Sulphate)

iii)Turbidity Method Turbidity Meter or Spectrophotometer`(420  Barium Chloride – Standard Solution

nm) (Barium chloride in hydrochloric acid
Detection limit 1 to Glass Apparatus ammonia)
40mg/l Hot Plate  Barium Chloride
Refrigerator (recommended)  Gelatin Powder
Filter – 0.45µm  Glycerol
 Hydrochloric Acid, Conc
 Sodium Chloride
 Ethyl or Isopropyl Alcohol
 Anhydrous Sodium Sulphate
 Stock sulphate solution – 100mg/l
14 Alkalinity 5.2, Sl. No. IS 3025 (P 23): 1986
xiv) of with Amendment 1& 2
 pH Meter  Distilled Water
Table 2 i) Indicator Method  Burette  Sulphuric Acid, Conc
 Magnetic Stirrer Assembly  Sulphuric Acid, 0.02 N
Detection range 0.5 to  Beaker  Phenolphthalein Indicator
500mg/l  Mixed Indicator Solution (Methyl Red,
Bromocresol Green, Ethyl or Isoprophyl
Alcohol)

ii)Potentiometric  Potentiometer  Standard Sulphuric Acid – 0.02N

Method  Glasswares

Detection range 0.5 to

500mg/l

89
15 Calcium 5.2, Sl. No. i) IS 3025 (P40): 1991  Sodium Hydroxide Solution – 1N
xv) of Table with Amendment 1  Hydrochloric Acid – 0.1N
2  Indicator Solution:Murexide (Ammonium
Purpurate) Indicator, Absolute Ethylene
Glycol Sodium Chloride
OR

Patton and Reeder’s Indicator (Eriochrome

 Hot Plate Blue Black R, Sodium Sulphate/Potassium
a)EDTA Titrimetric  Glasswares Sulphate)
Method  Polyethylene Bottle
 Standard EDTA Solution – 0.01M
(Disodium Ethylene Diamine Tetra –
Acetate, Standard Zinc Solution, (Or Standard
Calcium Solution) Buffer Solution,
Eriochrome Black T Indicator Solution

 Stock Calcium Solution (Calcium

Carbonate, Hydrochloric Acid – 0.1N)
 Nitric Acid, Conc

b)Atomic Absorption
Spectrometric Method Atomic Absorption Spectrometer (422.7 nm )
with Air/Acetylene or Nitrous Oxide/Acetylene  Hydrochloric Acid – 1N and 0.1N
Detection limit Flame and Hollow Cathode Lamp (Calcium)  Lanthanum Chloride
 Cesium Chloride
maximum 50mg/l
 Standard Calcium Solution

c) Permanganate  Hydrochloric Acid – 1N

Titration Method  Beakers, Cover Glass, and Glass Rod  Methyl Red Indicator Solution
 Filtration Set up (Gooch Crucible with  Ammonium Oxalate Solution
Suction)  Urea
Hot plate  Dilute Sulphuric Acid – 1N
 Sodium Oxalate
 Standard Potassium Permanganate
Solution (Potassium permanganate,
sodium oxalate)

90
 ii)IS 3025(Part 2)
Inductively Coupled
Plasma Atomic
Emission Spectroscopy
(a e s)
Detection limit
0.1 mg/l
 ICP AES ( 315.887 nm) including -  Nitric Acid
 Hydrogen Peroxide
 computer controlled a e s with background  Sulphuric Acid
correction  Hydrochloric Acid
 Ammonium Sulphate
 radio frequency generator  Distilled Water
 Calcium Stock solution ( 10 mg/l )
 argon gas supply ( welding grade or better)
 Sample bottles
 Glassware ( beakers, filter funnels,
volumetric flasks, pipettes)

 acid dispensers

 Membrane filtration equipment

 filter of pore size 0.45 microns

16 Magnesium 5.2, Sl No. i) IS 3025 (P 46): 1994

xvi) of Table with Amendment 1 & 2
2  Vacuum Pump  Methyl Red Indicator
 Filter Flasks  Hydrochloric Acid
 Filter Crucibles ( medium porosity, 30 ml)  Ammonium Oxalate
a)Gravimetric Method  Muffle Furnace  Ammonium Hydroxide
 Nitric Acid, Conc
Detection limit more  Diammonium Hydrogen Phosphate
than 1 mg/l  Urea

91
 -Hot plate
-Volumetric Flasks  Indicator Solutions
-Glasswares i) Patton and Reeder Reagent, Sodium
Chloride/Potassium Chloride

b) Volumetric Method ii)Murexide (Ammonium Purpurate), Absolute

(EDTA) Ethylene Glycol, Sodium Chloride

iii)Eriochrome Black T Indicator (EBT

Indicator), Hydroxylamine Hydrochloride,
Ethanol/Methanol

 Standard Zinc Solution – 0.01M (Pure

Zinc Dust/Granules – 99.9% Pure;
Hydrochloric Acid)
 Buffer Solution (Ammonium Chloride,
Ammonia, Sodium Hydroxide-1N)
 Standard Ethylene Diamine Tetra Acetic
Acid (EDTA) Solution – 0.001M
(Disodium Ethylene Diamine Tetra
Acetate Dihydrate, Standard Zinc
Solution)
 Triethanolamine Solution – 10%
 Potassium Cyanide
 Hydroxlamine Hydrochloride

c)Atomic Absorption
Spectrophotometric Atomic Absorption Spectrophotometer (  Hydrochloric Acid – 1N and 0.1N
Method 285.2 nm ) with Air-Acetylene Flame or  Lanhanum Chloride (Lathanum Oxide,
Nitrous Hydrochloric Acid, Conc)
Oxide-Acetylene Flame and Hollow
Cathode Lamp (Magnesium)  Cesium Chloride
Detection limit max 5
Polyethylene Bottles  Standard Magnesium Solution (1000mg/l)
mg/l
(Magnesium Oxide, Hydrochloric
Acid)

92
 ii) IS 3025(Part 2)

Inductively Coupled
Plasma Atomic  Nitric Acid
Emission Spectroscopy ICP AES (279.079nm) including -  Hydrogen Peroxide
computer controlled aes with background  Sulphuric Acid
Detection limit correction  Hydrochloric Acid
radio frequency generator  Ammonium Sulphate
0.03 mg/l argon gas supply ( welding grade or better)  Distilled Water
Sample bottles  Magnesium Stock solution ( 10 mg/l )
Glassware ( beakers, filter funnels,
volumetric flasks, pipettes)
acid dispensers
Membrane filtration equipment

17 Sodium 5.2, Sl No. i) IS 3025 (P45): 1993

xvii) of Table with Amendment 1
2
a)Flame Emission
Photometric Method  Flame Photometer (Direct Reading OR  Deionized Distilled Water
Internal Standard Type) OR Atomic  Stock Sodium Solution – 1mg/ml (Sodium
anyone of the Absorption Spectrophotometer (In Chloride)
Flame Emission Mode)  Standard Lithium Solution – 1mg/ml
following applicable
detection range:(0 to  Glasswares
 pH meter
1)mg/lit(1 to  Weighing balance
10)mg/lit (0 to
100)mg/lit

b)Atomic Absorption
Spectrometry Method
Atomic Absorption Spectrophotometer  Sodium Chloride
Detection range 0.20 to with Air-Acetylene Flame and Hollow  Potassium Chloride
4.0mg/l Cathode Lamp (Sodium)  Stock Sodium Solution – 1mg/ml
 Stock Potassium Solution – 1mg/ml

93
 Glassware
 Beakers (20ml, Borosilicate)
c)Gravimetric Method  Fritted Glass Crucible or Porous Porcelain  Zinc Uranyl Acetate Reagent (Glacial
Crucibles Conc. Acetic Acid, Uranyl Acetate
 Vacuum Pump or Aspirator Dihydrate, Zinc Acetate Dihydrate,
Sodium Chloride)
 Filter paper  Ethyl Alcohol Wash Solution (Ethyl
Alcohol, Pure Sodium Zinc Uranyl
 Pyrex bottle Acetate, Sodium Chloride, Acetic Acid,
 Stirring rod Diethyl Ether)

ii) IS 3025(Part
2):2004  Oven
 Membrane filtration equipment and
 Nitric acid
filters(0.45µm)
 Hydrogen peroxide
 Inductively coupled plasma atomic emission
 Sulphuric acid
spectrometer; Computer controlled AAS with
background correction, Radiofrequency  Hydrochloric acid
Generator, Argon Gas supply(welding grade or  Ammonium sulphate
better)  Sodium Stock solution
 pH meter
 PTFE container
 PTFE sample bottles(250 ml or 500ml)
 Acid dispensers, Variables

18 Residual 5.2, Sl No. IS 3025 (P 26): 1986

Free xviii) of Stabilized Neutral
Chlorine Table 2 Ortho-Toluidine Method

Detection range 0.005  Spectrophotometer ( w i t h l i g h t p a t h Distilled Water – Chlorine Demand Free

to 0.01mg/l of 1c m c ell or longer f or ≤
1 mg/ l) (Distilled Water, Chlorine)
This requirement is not  Magnetic Stirrer Assembly
applicable for PNMW Neutral Ortho-Toluidine Reagent
 Refrigerator (Recommended) (Hydrochloric Acid – Conc, Mercuric
Chloride, Disodium Salt of EDTA –

94
 pH meter Dehydrated, Ortho-Toluidine
Dihydrochloride Buffer Stabilizer
 Brown Glass Stoppered Bottles Reagent (Dipotassium Hydrogen
Phosphate, Potassium Dihydrogen
Phosphate, Di (2-Ethyl Hexyl)
Sulphosuccinate, Diethylene Glycol
Monobutyl ether

Potassium Iodide Solution (Potassium

Iodide

Sulphuric Acid Conc. Sodium Carbonate

Sodium Arsenite

Standard Chlorine Solution (Chlorine Gas

&

Distilled Water OR Hypochlorite

Solution) Sodium Thiosulphate Solution
– 0.025N)

20 Mineral Oil 5.2, Sl No IS 3025 (P 39): 1991

.xx) of Table with Amendment 1
2  Separating Funnel (1lit) with Teflon or  Hydrochloric Acid
Partition Infra-Red Equivalent Stopcock  Hexane
Method  Infra-Red Spectrophotometer – Double  Sodium Sulphate, Anhydrous
Beam, Recording type  Reference Oil (Iso-Octane, Hexadecane,
 Cells – Infra-Red, Silica Benzene)
 Filter Paper – Whatman No.40 or  Trichlorotrifluoroethane
Detection limit 0.5 to Equivalent, 11cm Diameter
100 mg/l  Analytical Balance

95
21 Anionic 5.2, Sl No. Annex K of  pH Meter  Sodium Chloride
Surface xxi) of Table  Spectrophotometer (650 nm) 10mm &  Ethyl Acetate
Active 2 IS 13428:2005 50mm cells  Al2O3
Agents (as  Gas Stripping Apparatus (1 lit Capacity)  Chloroform
MBAS)  Nitrogen Air (20 ltr/hr to 50 ltr/hr)  Ethanol
 Reflux Condenser  Methanol
Detection limit about  Fume hood  Sulphuric Acid
 Water bath  Ethanolic Sodium Hydroxide-0.1
0.05 mg/l mol/lit (Sodium Hydroxide, Ethanol)
 Methylene Blue, Neutral Solution
 Methylene Blue, Acidic Solution
 Bufer Solution, pH 10 (Sodium
CHydrogen Carbonate, Anhydrous
Sodium Carbonate)
 Phenolphthalein Indicator, Ethanol
 Dodecyl Benzene Sulphonic Acid Methyl
Ester (Tetrapropylene Type), Stock
Standard Solution
22 Sulphide 5.2, Sl. No. IS 3025 (P 29): 1986  Zinc acetate solution – 2N
xxii) of Table  Sulphuric Acid, Conc.
2 i) Iodometric Method  Glass Fibre Filter Paper.  Standard Iodine solution – 0.025 N
 Reaction Flask (1 lit capacity with 2 (Potassium Iodide, Iodine)
Detection limit above 1 holestopper fitted with gas-diffusion  Hydrochloric Acid, Conc.
mg/l tube.  Standard Thiosulphate Solution - 0.025
 Absorption flasks (250ml Capacity) (2 N (Sodium thiosulphate, Sodium
No’s) Hydroxide/Chloroform)
 Nitrogen/Carbon dioxide gas cylinder  Starch indicator solution (Starch, salicylic
Or Carbon dioxide gas generator acid, toluene)
 Aluminium Chloride solution – 6N
 Sodium hydroxide – 6N

ii) Methylene blue

method  N, N-dimethyl-p-Phenylene Diamine
 Spectrophotometer (664 nm) or oxalate
Detection limit upto 20 filterphotometer (600 nm).
mg/l  Matched test tubes  Sulphuric Acid, Conc. & 1:1 solution

96
  Droppers  Ferric Chloride
Dark glass bottle.  Diammonium Hydrogen Phosphate
 Methylene Blue
 Standard Sulphide Solution
Zinc acetate

23 Antimony 5.2 Sl. No. i) Annex G of

xxiii) of IS 13428:2005
Table 2  Spectrophotometer (565 nm)  Hydrochloric Acid – 6 N
Spectrophoto-metric  Erlenmeyer Flask (125ml)  Phosphoric Acid – 3N
Method  Seperating Funnels (125 ml) with Teflon  Rhodamine B
Stopcocks  Antimony Standard Solution (100
 Refrigerator µg/ml and 1 ug/ml (pure antimony,
 Ice Bath
 Test Tubes sulphuric acid)
 Pipettes
Benzene
 Sulphuric Acid
 Perchloric Acid

ii) IS 15303:2003 Atomic Absorption Spectrometer with

 Hollow Cathode Lamp OR
Electrothermal  Electrodeless discharge lamp (EDL).
Atomic Absorption
 Graphic Furnace
Spectrometric Method
 Readout Mechanism
 Microlitre Pipettes-5 to 100 µl. OR
 Automatic sampling device designed
for the specific instrument.
 Vent for Fumes
 Cooling Device
 Membrance Filter Apparatus
(0.45µm) or smaller pore diameter
membrane filters.
 Metal free Water
 Hydrochloric Acid, Conc.
 Nitric Acid, Conc.
 Matrix Modifier Stock Solutions
(Magnesium Nitrate, Nickel Nitrate,
Phosphoric Acid, Palladium Nitrate, Citric
Acid)
 Stock MetalSolution
 Antimony Solutions (100 µg/m Sb)
 Iron-100µg Fe
 Selenam-1.00 mg Sb
 Chelating Resin
 Sodium hydroxide -10 N

97
24 Borates 5.2, Sl. No. Annex H of IS  Spectrometer (410 – 420nm)  Azomethine – H, Sodium Salt
xxiv) of 13428:2005  Lab Apparatus made of  L + - Ascorbic Acid
Table 2 Polypropylene/Polyethylene/Polytetrafluoro  Buffer Solution (pH 5.9) [Ammonium
Ethylene Acetate, Sulphuric Acid, Phosphoric Acid,
 Refrigerator Citric Acid, Disodium Ethylene diamine
– Tetraacetic Acid Dihydrate]
 Borate Stock Solution - (1mg/ml) (Boric
Acid)
 Boron Standard Solution - 10µg/ml
 Calcium Hydroxide

98
 C - REQUIREMENTS FOR TOXIC SUBSTANCES

MERCURY 5.2, Sl. IS 3025 (P 48): 1994  Atomic Absorption Spectrometer and Associated  Sulphuric acid, conc.
1 No. i) with Amendment 1 Equipment (Cold Vapour Technique)  Nitric acid, Conc.
of  Mercury Vapour Generation Assembly  Stannous chloride
Table 3 i) Cold Vapour  Mercury Hollow Cathode Lamp  Hydrochloric acid, Conc.
Atomic Absorption  Recorder/Printer/Display Meter  Sodium chloride
Spectrophotometry  BOD bottle, 300 ml  Hydroxylamine sulphate
 Water bath  Potassium permanganate
 Equipment assembly as per Fig 1  Potassium persulphate
 Mercuric chloride
Detection limit  Mercury free distilled water
0.0002 mg/l, Min

ii) Colorimetric  Spectrophotometer  Redistilled or Deionised Distilled Water

Dithizone Method  Separating Funnels (250 and 1000ml with PTFE (Mercury free)
stopcocks)  Mercuric chloride
 Glass wares  Nitric acid, Conc.
Detection limit  Whatman Filter No. 42  Potassium permanganate
0.002 mg/l, Min  Potassium persulphate
 Hydroxylamine hydrochloride
 Dithiozone solution, 6 µg/ml
 Sulphuric acid – 0.25 N
 Potassium bromide
 Chloroform
 Disodium hydrogen phosphate
 Anhydrous potassium carbonate
 Sodium sulphate, Anhydrous
 Hydrochloric acid (1:1)
 Ammonium hydroxide

99
 CADMIUM 5.2, Sl. IS 3025 (P 41): 1992  Atomic Absorption spectrophotometer  Hydrochloric acid, Conc.
2 No. ii) with Air-Acetylene Flame  Nitric acid, Conc.
of i) Atomic Absorption  Cadmium Hollow Cathode Lamp or  Nitric acid, dilute – 1:499
Table 3 Method (Direct) Multi Element Hollow Cathode Lamp  Pure Cadmium Metal
for Use at 228.8 nm
Detection range
0.05 to 2mg/l

ii) Atomic Absorption  Atomic Absorption spectrophotometer  Hydrochloric acid, Conc.

Method (Chelation with Air-Acetylene Flame  Hydrochloric acid – 1:49
and Extraction)  Cadmium Hollow Cathode Lamp or  Nitric acid, Conc.
Detection range Multi Element Hollow Cathode Lamp  Nitric acid, dilute – 1:499
0.005 to 0.2mg/l for Use at 228.8 nm  Pure Cadmium Metal
 Separating funnel  Sodium hydroxide
 pH meter  Methyl Isobutyl Ketone (MIBK)
 pH paper  Bromophenol Blue
 Ethanol or Isopropanol
 Pyrrolidine dithiocarbamic acid
 Carbon Disulphide

iii) Differential Pulse  Hydrochloric Acid, Conc., spectrograde

 Polarograph – Capable of Differential Pulse Work
Anodic Stripping  Nitric Acid, Conc., spectrograde
Voltametry  Hanging MercuryDrop Electrode
 Nitric Acid, dil – 1:1
 Platinum Counter Electrode
 Hydroxylamine Hydrochloride
Detection range  Saturated calomel Reference Electrode
 L-Ascorbic Acid
0.0001 to 0.1mg/l  Magnetic Stirrer Control Unit with Stirring Bar
 Pure Cadmium Metal
 Nitrogen Gas (Cylinder)
 Granular Zinc
 Scrubber assembly for nitrogen purification
 Mercury
 Voltametric Cell assembly  Ammonium Meta Vanadate

3 ARSENIC 5.2, Sl. IS 3025(P 37): 1988

No. iii)  Atomic absorption spectrometer equipped with gas  Argon or Nitrogen and Hydrogen
of i) Atomic absorp tion flow meter for Argon or Nitrogen and Hydrogen  Sodium borohydride
Table 3 method and with arsenic electrode less discharge lamp  Sodium hydroxide
 Atomizer  Sodium Iodide
Detection limit  Reaction cell for producing arsenic hydride  Sulphuric acid-18N & 2.5 N
0.001 mg/l  Eye dropper or syringe  Potassium persulphate
 Refrigerator  Nitric acid, conc

100
  Perchloric acid, conc
 Hydrochloric acid, conc
 Arsenic trioxide
 Arsenic pentaoxide
 Dimethyl arsenic acid/cacodylic acid
 Calcium chloride

 Hydrochoric acid , Conc

ii) Silver diethyl Arsine generator & absorption assembly
 Potassium Iodide
dithiocarbamate (Fig 2 of IS 3025 Pt 37)
method Spectrophotometer, 535 nm with 1 cm cells  Stannous chloride, arsenic free
(Refree method)  Lead acetate
Detection limit  Ephedrine
0.001 mg/l  Pyridine
 Chloroform
 Silver diethyl dithiocarbamate
 Zinc – 20 to 30 mesh, arsenic free
 Arsenic trioxide
 Sodium hydroxide

iii) Mercuric bromide Arsine generator glass assembly (Fig 3 of IS  Sulphuric acid (1:1)
stain method 3025  Nitric acid, conc
Pt 37)  Roll cotton
Detection limit  Lead acetate
0.001mg /l  Arsenic papers
 Mercuric bromide
 Ethyl alcohol/isopropanol
 Potassium iodide
 Arsenic free stannous chloride
 Zinc-20 to 30 Mesh, arsenic free
 Arsenic trioxide
 Sodium hydroxide
CYANIDE 5.2, Sl. IS 3025(P.27): 1986
4 No. iv) with
of Amendment 1
Table 3  Distillation apparatus consisting of boiling flask,  Sodium hydroxide
i) Total cyanide after 1l, thistle tube, Allihn water cooled condenser, gas  Lead carbonate-powdered
distillation method dispersion tube, needle valve, suction flask and  Sulphamic acid

101
 suction pump (Fig 1 of IS 3025 Pt 27)  Magnesium chloride
Detection limit  Heating mantle  Sulphuric acid, conc
minimum 0.02 mg/l  Gas absorber  Acetic acid, glacial
 Ground glass ST joints  Potassium cyanide
 Spectrophotometer for use at 62 nm with 1-cm cell  Silver nitrate
 pH paper  Chloramine - T
 Thermometer – 0oC – 1100C, l.c. 1oC  Pyridine
 Pyrazolone
 BIS – pyrazolone

 Potassium cyanide
 Expanded – scale pH meter or specific Ion meter  Silver nitrate
ii) Selective electrode
 Cyanide Ion selective electrode  Sodium hydroxide
method
 Reference electrode, double junction  Potassium nitrate
Detection range  Magnetic mixer with TFE coated stirring Bar  Potassium hydroxide
0.05 to 10 mg/l

5 LEAD 5.2, Sl. IS 3025(P 47): 1994

No. v) with  Hydrochloric acid, conc
of Amendment 1 & 2  Atomic absorption spectrophotometer with air  Nitric acid, conc.
Table 3 i) Atomic absorption acetylene flame  (Lead nitrate
method (direct)  Hollow cathode lamp OR Electrodeless Discharge  Nitric acid, dil (1:499)
lamp for use at 283.3 nm
Detection range
1.0 to 10.0mg/l
 Hydrochloric acid, conc
ii) Atomic absorption  Hydrochloric acid, dil (1:2)
method (chelation –  Atomic absorption spectrophotometer with air  Hydrochloric acid, dil (1:49)
extraction) acetylene flame  Nitric acid, conc.
 Hollow cathode lamp OR Electrode less Discharge  Pyrrolidine
Detection range lamp for use at 283.3 nm
0.1 to 1.0 mg/l (with  Chloroform
 Separatory funnel  Carbon disulphide
graphite system  0.45µm membrane filter
0.001 mg/l)  Sodium hydroxide
 Acid washed filter paper  Bromophenol blue
 pH meter  Lead nitrate

102
 iii) Differential pulse
anodic stripping
voltametry (DPASV)  Polarograph capable of performing differential  Lead nitrate
pulse work  Hydrochloric acid, conc.
Detection range  Hanging mercury drop electrode  Nitric acid, conc.
0.001 to 0.1mg/l  Platinum counter electrode  Nitric acid, dil (1:1)
 Saturated calomel reference electrode  Granular zinc
 Magnetic stirrer control unit with stirring bar  Mercury
 Scrubber assembly for nitrogen purification  Ammonium metavandate
 Nitrogen gas (cylinder)
 0.45µm membrane filter

iv) Dithizone method

 Spectrophotometer for use at 510 nm with 1-cm  Lead free distilled water
Detection limit
cell  Lead nitrate
0.1 mg/l
 pH meter  Nitric acid, 95% (w/w)
 TEF beakers, 100 ml  Nitric acid, dil 20% (w/w)
 Separating funnels, 250 ml, 500 ml  Nitric acid, dil (1:1)
 Ammonium hydroxide Conc. (14 N)
 Ammonium hydroxide, dil. 10% ( v/v)
 Ammonium hydroxide, dil. 1% v/v)
 Anhydrous Ammonium Citrate
 Anhydrous Sodium Sulphite
 Hydroxylamine hydrochloride
 Potassium cyanide
 Dithizone
 Chloroform
 Hydrochloric acid (1:1)
CHROMIUM
6 5.2, Sl. Annex J of IS  Atomic absorption spectrophotometer with  Deionised distilled water, Ammonia free
No. vi) 13428:2005 reducing Air – acetylene flame  Nitric acid, redistilled – 1:1 (v/v)
of  0.45µm membrane filter  Hydrochloric acid, redistilled – 1:1 (v/v)
Table 3  pH meter  Chromium oxide
 Centrifuge  Lanthanum chloride
 Lanthanum oxide , 99.9%, w/w
 Ammonium pyrrolidine dithocarbamate

103
7 5.2, Sl. Annex L of IS  Atomic absorption spectrophotometer with  Nitric acid, conc. – 1.4 g/ml
No. vii) 13428:2005 nebulizer – burner having air- acetylene flame  Pure nickel metal
NICKEL of  Centrifuge  Sodium hydroxide
Table 3  Nickel hollow cathode lamp/electrode less  Hydrochloric acid, conc. – 1.19 g/ml
discharge lamp  Methyl isobutyleketone (MIBK)
 Separating funnel, 250-ml with PTFE taps  Ammonium 1 – pyrrolidino
 pH meter carbodithioate
 Bromophenol blue
 Ethanol

8 POLY 5.2, Sl. Annex M of  Gas chromatograph with EC detector & coupled  Silica gel, 60 – 100 mesh
CHLORINATED No. IS 13428:2005 with printer-plotter-cum- integrator  N-hexane-redistilled
BIPHENYLE viii) of  Glass chromatographic column, 300 mm long, 8  Potassium hydroxide pellets
(PCB) Table 3 mm ID with ground glass socket at the upper end  Sodium hydroxide solution – 5N
and a stop cock at low end.  Diethyl ether, chromatography grade
 Kuderna-Danish type, evaporator  Cotton wool, extracted with hexane and
 Snyder columns diethyl ether
 Syringe (5 µl)  Acetic acid, glacial, redistilled
 Heating oven  Chromium trioxide, re-crystallized
 Desiccator  Apiezon L grease
 Epikote Resin 1001 – 0.15 %
 Chromosorb G (acid washed) DMCS
treated, 60 – 80 mesh
 Silicone gum GE-S-SI – 1.3 %
POLYNUCLEAR
9 AROMATIC 5.2, Sl. i) High Performance  High Performance Liquid Chromatograph  Reagent Water
HYDROCARBON No. ix) Liquid (HPLC) complete with gradient pumping system,  Sodium thiosulphate, granular
of Chromatography reverse phase column and detectors (UV and  Cyclohexane
Table 3 fluorescence)  Methanol
(HPLC) Method
APHA  Acetone,
6440  Gas Chromatograph (GC) complete with column  Methylene chloride
ii) Gas and flame ionization detector.
chromatographic  Pentane – Pesticide quality or
 Separating funnel (2 l) equivalent.
(GC) Method  Evaporative flask  Acetonitrile – HPLC quality
 Three Ball Synder column  Sodium sulphate, granular, anhydrous
 Kuderna- Danish Apparatus  Silica Gel – 100/200 mesh

104
  Water bath (60-65˚C)  Stock standard solution
 Std. PAHs Solutions –
(a) 100 µg/ml of naphthalene,
acenaphthylene, fluorine,
phneanthrene and anthracene.
(b) 5µg/ml Benzo (k) fluoranthene

*Note: Besides listed Equipments/Apparatus/Chemicals, following accessories are essential part of a chemical lab:

i) General glass wares like Pipettes Burette, Conical flasks, Beakers, Measuring cylinders, Volumetric flasks, (of different volumes)

ii) Provision for distilled/double distilled water

iii) Fuming Hood and sink with tap in the lab

# The list does not cover the requirements of Pesticide Residues and Radio Active Residues as these requirements are got to be tested from outside approved
lab.

105
 D - MICROBIOLOGICAL REQUIREMENTS

General microbiological lab equipments **

 Hot air oven (capable of 180 ºC).

 Autoclave (capable of 15 psi/ 121 ºC) of suitable size as per need.
 Weighing Balance with least count 0.01 g (least count 0.001 g, if Tergitol-7 agar medium or Crystal violet neutral red bile lactose (VRBL) agar is being
prepared in house).
 pH meter with least count 0.1 pH unit.
 Laminar air flow chamber OR inoculation room/cabinet fitted with U.V. tube light.
 Hot plate for media preparation.
 Membrane filtration assembly (including sterilized membrane filters of 47 mm to 50 mm diameter with 0.45 µm pore size, vacuum pump (for applying
vacuum of about 70 kPa) and forceps with rounded tips).
 Inoculation loop/needle.
 Bunsen burner with LPG cylinder.
 Thermostatically controlled water bath.
 Air conditioner (recommended)
 Refrigerator
 Colony counting equipment (recommended)
 General glasswares including, petri dishes (made of glass or plastic), volumetric pipettes (of capacity 1 ml and 10 ml), flasks, test tubes, culture bottles,
funnels, glass rod, measuring cylinders.
 Thermometer with least count 1 °C
 Filter Paper
 Cotton

Sl Parameter Clause Referred Method Test Equipment/Apparatus ** Chemicals/Media/Reagents **

No. Ref. of Test

(1) (2) (3) (4) (5) (6)

1 Escherichia 5.1.1 of IS i) Reference  General microbiological lab equipments  Distilled water

coli (or 14543 : method (as listed above)  MacConkey broth medium – (Peptone, Sodium
thermotolerant 2004 taurocholate or Bile salts, Sodium chloride, Lactose,
bacteria) IS 5887 (Part 1) : Neutral red, Ethanol)
6.1.1 of IS  Incubator capable of maintaining 37 °C

106
13428 : 1976
2005
@
 Incubator capable of maintaining 44 °C  MacConkey agar medium – (MacConkey Broth, Agar)
(for test for growth with acid and gas
production in MacConkey broth)
 Eosin methylene blue lactose agar medium – (Peptone,
Dipotassium hydrogen phosphate, Agar, Lactose, Eosin
@
 Glass tubes open at both ends (for Y, Methylene blue)
motility test)

 Tergitol-7 agar medium – (Proteose peptone, Yeast

@
 Seitz filtration assembly (for sterilizing extract, Lactose, Agar, Tergitol-7, Bromothymol blue)
solution of urea for preparing medium for
urease test)
@
 Nutrient broth – (Peptone, Meat extract, Sodium
chloride)
 Durham’s fermentation tubes (for  @ Nutrient agar – (Nutrient broth, Agar)
carbohydrate fermentation test)

@
 TSI medium for H2S test – (Meat extract, Yeast
@
 Microscope and Glass slides (for Gram extract, Peptone, Glucose, Lactose, Sucrose, Ferrous
staining) sulphate, Sodium chloride, Sodium thiosulphate, Agar,
Phenol red)

@
 Medium for urease test – (Peptone, Sodium chloride,
Agar, Potassium dihydrogen phosphate, Phenol red,
Glucose, Urea)

@
 Protease species as control for urease test (optional)

@
 Medium for indole production – (Peptone, Sodium
chloride, Strain of bacterium known to produce indole)

@
 Kovac’s reagent (for indole test) – (p-Dimethyl-
aminobenzaldehyde, Amyl alcohol or Iso-amyl alcohol,

107
 Concentrated hydrochloric acid)

@
 Medium for methyl red and Voges-Proskauer tests –
(Peptone, Dipotassium hydrogen phosphate, Glucose)

@
 Methyl red, absolute ethanol (for methyl red test)

@
 α-naphthol, ethanol, potassium hydroxide (for Voges-
Proskauer Reaction)

@
 Simmon’s citrate agar – (Sodium chloride,
Magnesium sulphate, Ammonium dihydrogen
phosphate, Dipotassium hydrogen phosphate, Sodium
citrate, Agar, Bromothymol blue)

@
 Peptone water medium (for carbohydrate
fermentation test) – (Peptone, Sodium chloride,
Andrade’s indicator, Sugar)

@
 Andrade’s indicator (for Peptone water medium for
carbohydrate fermentation tests) – (Sodium hydroxide,
Acid fuschin)

@
 Gram stain – (Methyl violet or Crystal violet, Iodine,
Potassium iodide; Neutral red, Acetic acid, Ethanol)

@
 Lactose (for carbohydrate fermentation test)

108
ii) IS 15185 :  General microbiological lab equipments  Distilled water
2002 (as listed above)

 Lactose TTC agar with sodium heptadecylsulphate –

 Water bath and/or incubator (Lactose, Peptone, Yeast extract, Meat extract,
a) Standard Test thermostatically controlled (36 ± 2 °C and Bromothymol blue, Agar; 2,3,5 Triphenyltetrazolium
44.0 ± 0.5 °C chloride (TTC), Sodium heptadecylsulphate (Tergitol-
7))

 Membrane filter of 0.2 µm pore size (for

sterilizing TTC solution during preparation  Tryptone soy agar (TSA) – (Tryptic digest of casein,
of Lactose TTC agar) Soy peptone, Sodium chloride, Agar)

 Tryptone broth – (Tryptic digest of casein, L-

tryptophan, Sodium chloride)

 Oxidase reagent – (Tetramethyl-p-phenylene diamine

hydrochloride)

 Kovac’s Reagent – (p-Dimethylaminobenzaldehyde,

Amyl or butyl alcohol , Concentrated hydrochloric
acid)
b) Rapid test  General microbiological lab equipments  Distilled water
(Optional) (as listed above)
 Ultra violet lamp, wavelength 254 nm (low
pressure mercury lamp)  Tryptone soy agar (TSA) – (Tryptic digest of casein,
Soy peptone, Sodium chloride, Agar)

 Filter pads, with a diameter of at least 47

mm.  Tryptone bile agar (TBA) – (Tryptone, Bile salts,
Agar)

 Water bath and/or incubator

thermostatically controlled (36 ± 2 °C and  Indole reagent – (p-Dimethylaminobenzaldehyde,
44.0 ± 0.5 °C  Concentrated hydrochloric acid)

109
2 Coliform 5.1.2 of IS i) Reference  General microbiological lab equipments  Distilled water
Bacteria 14543 : method (as listed above)
2004
IS 5401 (Pt. 1) :  Crystal violet neutral red bile lactose (VRBL) agar –
6.1.2 of IS 2012  Incubator capable of operating at 30 ºC ± (Enzymatic digest of animal tissues, Yeast extract,
13428 : 1 ºC or 37 ºC ± 1 ºC Lactose, Sodium chloride, Bile salts, Neutral red,
Crystal violet, Agar)
2005
@
 Test tubes of dimensions approximately
@
16 mm x 160 mm  Brilliant green lactose bile broth – (Enzymatic digest
of casein, Lactose, Dehydrated ox bile, Brilliant green)
@
 Durham tubes of dimensions appropriate
for use with the test tubes

ii) IS 15185 :  General microbiological lab equipments  Distilled water

2002 (as listed above)  Lactose TTC agar with sodium heptadecylsulphate –
(Lactose, Peptone, Yeast extract, Meat extract,
Bromothymol blue, Agar; 2,3,5 Triphenyltetrazolium
 Water bath and/or incubator chloride (TTC), Sodium heptadecylsulphate (Tergitol-
Standard Test thermostatically controlled (36 ± 2 °C and 7))
44.0 ± 0.5 °C  Tryptone soy agar (TSA) – (Tryptic digest of casein,
Soy peptone, Sodium chloride, Agar)

 Membrane filter of 0.2 µm pore size (for

sterilizing TTC solution during preparation  Tryptone broth – (Tryptic digest of casein, L-
of Lactose TTC agar) tryptophan, Sodium chloride)

 Oxidase reagent – (Tetramethyl-p-phenylene diamine

hydrochloride)

 Kovac’s Reagent – (p-Dimethylaminobenzaldehyde,

Amyl or butyl alcohol , Concentrated hydrochloric
acid)

110
 Rapid test  General microbiological lab equipments  Distilled water
(Optional) (as listed above)

 Tryptone soy agar (TSA) – (Tryptic digest of casein,

 Ultra violet lamp, wavelength 254 nm (low Soy peptone, Sodium chloride, Agar)
pressure mercury lamp)

 Tryptone bile agar (TBA) – (Tryptone, Bile salts,

 Filter pads, with a diameter of at least 47 Agar)
mm.

 Indole reagent – (p-Dimethylaminobenzaldehyde,

 Water bath and/or incubator Concentrated hydrochloric acid)
thermostatically controlled (36 ± 2 °C and
44.0 ± 0.5 °C
3 Sulphite 5.1.4 of IS Annex C of IS  General microbiological lab equipments  Distilled water
reducing 14543 : 13428 : 2005 (as listed above)
anaerobes 2004  Screw cap bottles or vials and stoppers of
boron silicate glass of capacities 200, 100  Differential reinforced clostridial medium (DRCM) –
6.1.4 of IS and 25 ml (Peptone tryptic digest of meat , Meat extract, Yeast
13428 :  Test tubes - 150 mm x 13 mm extract, Starch, Hydrated sodium acetate, Glucose, L-
cysteine-hydrochloride, Sodium hydroxide)
2005
 Iron wire
 Sodium sulphite

 Incubator (37 ºC ± 1 ºC)

 Iron (III) citrate

 Anaerobic jar assembly (recommended)

4 Pseudomonas 5.1.5 of IS Annex D of IS  General microbiological lab equipments  Distilled water
aeruginosa 14543 : 13428 : 2005 (as listed above)
2004  Medium for determination of presumed Pseudomonas
aeruginosa – (DL asparagine, L proline, Anhydrous
6.1.5 of IS  Screw capped bottles dipotassium hydrogen phosphate, Magnesium sulphate
13428 : heptahydrate, Anhydrous potassium sulphate, Ethanol)
2005
 Incubator (37 ± 1° C)
@
 Confirmatory medium (Milk agar medium) – [Skim

111

 UV cabinet fitted with UV lamp emitting
light of wavelength 360 ± 20 nm
 Magnetic stirrer (recommended)
 Cellulose acetate or nitrate membrane of
pore size 0.22 µm (for alternate
sterilization of ethanol)
milk powder, Bacteriological yeast extract, Peptone,
Sodium chloride, Agar hexadecyltrimethyl ammonium
bromide (centrimide)]
@
Clause D-10 (NOTE) of IS 13428 : 2005 specifies
confirmation of non-pigmented strains as a further step, if
required. Annex 2D of IS 13428 : 2005 specifies
biochemical characteristics to be tested for this purpose.
No specific apparatus, media and reagents have been
specified for the same. It is specified that commercially
available identification kits may be used for this.

@
 Incubator, capable of being maintained
at 42 ± 0.5° C

5 Aerobic 5.1.6 of IS IS 5402 : 2012  General microbiological lab equipments  Distilled water
Microbial 14543 : (as listed above)
Count 2004
 Plate count agar (PCA) – (Enzymatic digestion of
This  Incubators 21 ºC ± 1 ºC and 37 ºC casein, Yeast extract, Glucose anhydrous, Agar)
requirement is
not applicable
 Colony counting equipment  Overlay medium (if necessary) – Agar
for Packaged
Natural
Mineral Water

6 Yeast and 5.1.7 of IS IS 5403 : 1999  General microbiological lab equipments  Distilled water
Mould 14543 : (as listed above)
2004
 Yeast extract-dextrose-chloramphenicol-agar medium
6.1.6 of IS  Incubator (25 ± 1 ºC) – (Yeast extract, Dextrose, Chloramphenicol or
13428 : Oxytetracycline hydrochloride, Agar)
2005

112
** NOTES

Note 1 – The list does not cover the following requirements, as these parameters are got to be tested from outside approved lab:

i) Faecal streptococci and Staphylococcus aureus.

ii) Salmonella and Shigella.

iii) Vibrio cholera and V. parahaemolyticus.

Note 2 – General Microbiological Lab Equipments as listed are common for various microbiological tests. Other additional equipments required for specific test
methods are indicated against each parameter.

Note 3 – For preparation of culture media and reagents ingredients of uniform quality and chemicals of analytical reagent grade should be used. Alternatively,
commercially available media and reagents may be used provided their composition comply with those given in Indian Standards.

Note 4 – Disposable glassware may be accepted as an alternative to re-usable glassware.

Note 5 – All efforts have been made to compile the list as per the respective standards exhaustively covering all the required test equipments, apparatus and
chemicals. However, in case any omission or incorrectness is noticed while referring, the same may be conveyed to CMD immediately for suitable actions.

@
The marked equipments/ chemicals and media are required for confirmatory tests of respective microorganisms. The confirmatory test may be dispensed
with/omitted, provided the licensee undertakes to start corrective actions based on presumptive presence of microorganisms.

113
 E - REQUIREMENTS FOR BOTTLES/CONTAINERS FOR PACKAGED WATER

Sl. Clause No. Specified Test Facility Range and Accuracy/ Method of Test/
No. of IS Requirement Requirement Least Count ( If and Remarks (If any)
15410:2003 as Applicable)
1 4.1 Material --- ---- Raw Material
conformity to ISs is
indicated
2 4.2 Design, Shape Visual -----
4.2.1 and Dimensions
3 4.3 Manufacture,
Workmanship,
4.3.1 Finish and ----- To adhere GMP
4.3.2 Appearance Visual ----- --
4 4.4 Capacity Weighing Balance Suitable range with , Cl 5 of IS 2798
LC 0.1 g for Balance
or or
Measuring Cylinder 1 ml for Cylinder
5 4.5 Wall Thickness Micrometer Suitable Range with Cl 4.5 of IS 2798
LC 0.02 mm
6 4.6.2 Transparency Transparency/ Haze Meter Range upto 100 %, Annex A of
LC 1% IS 15410
7 4.6.3 Leakage Test Vibration Leakage Tester as per Cl. 6.2.1 of - Cl 6 of IS 2798
IS 2798
Reservoir
Air Pressure Leakage Tester
8 4.6.4 Drop Test Drop Tester with height of 0.5 m Cl 8 of IS 2798
9 4.6.5 Migration Test Oven/Water Bath Capable of IS 9845
Hot Plate maintaining
Analytical Balance 40+2° C
SS Evaporating Dish
Dessicator
Glass Beaker, pyrex, 1000 ml
Pouch Sealing Machine
10 4.6.6 Water Potability Conditioning Chamber Capable of Annex B of
Test maintaining 38+2° C IS 15410

114
 F- REQUIREMENTS FOR POLYETHYLENE FLEXIBLE POUCHES FOR PACKAGED WATER

Sl. Clause Specified Test Facility Range and Accuracy/ Method of Test/ Remarks (If any)
No. No. Requirement Requirement Least Count ( If and
as Applicable)
Clause 6.1 Requirements for Films
1 6.1.1 Description Visual -----------------
2 6.1.2 Film Form Visual -----------------
3 6.1.3 Winding of Film Visual -----------------
4 6.1.4 Odour Olfactory -----------------
5 6.1.5 Thickness Dead Weight Dial Suitable Range with A-2 of IS 2508
(65± 5µ/ 75± 5µ) Micrometer LC 1 µ
6 6.1.6 Width (in mm) Scale Suitable Range,
LC 1 mm
7 6.1.7 Overall Migration Oven/Water Bath Capable of IS 9845
Hot Plate maintaining 40 + 2o C
Analytical Balance
SS Evaporating Dish
Dessicator
Glass Beaker, pyrex, 1000 ml
Pouch Sealing Machine
8 6.1.8 Tensile Strength Tensile Testing Machine of LC 0.01 kN A-4 of IS 9845
suitable range

9. 6.1.9 Elongation at Tensile Testing Machine of LC 0.01 kN A-4 of IS 9845

break suitable range

10. 6.1.10 Dart Impact Dart Impact Tester with Drop Set of weights A-6 of IS 9845
Resistance Height of 66 cm (Min. Impact failure
load : 2.20 N)

Clause 7 Requirements for Pouches

11. 7.1 Vibration Vibration Table Table conforming to Annex D of
Leakage Test IS 7028 (Pt 2) IS 15609
Temp. - Ambient or

115
 27 + 20 C in Frequency of
case of dispute vibration 2 Hz
12. 7.2 Water Potability Oven/Heating Arrangement Capable of Annex E of
Test maintaining 38 + 2o C IS 15609
Pouch Sealing Machine
13. 7.3 Stack Load Test Flat Wooden Plank Set of weights for Annex F of
Temp. - Ambient or 20 N to 200 N IS 15609
27 + 20 C in
case of dispute

14. 7.4 Drop Test Arrangement for flat drop ----------- Annex G of
from 1.2 m height IS 15609

15. 7.5 Ink Adhesion Test Pressure Sensitive Tapes or 25 mm wide tape Annex H of
for Printed Pouch Cello- Tape IS 15609
Arrangement for
pulling tape at 10
mm/s at about 90 o

16. 7.6 Product Paper Tissue -------------- Annex J of

Resistance Test IS 15609
for Printed Pouch

Clause 8 Construction
17. 8 Construction Visual -----------------

116
 Amendment No.1 to PDW Manual Doc No.SM/IS 14543 & IS 13428/03, JULY 2013

Clause 4.10 - add the following text after Note 1

Note 2 - There may be cases when the sample of container drawn during the preliminary
inspection or verification visit (under simplified procedure), before GOL, is found to be
failing in ONLY the requirements of:

a) wall thickness which is evaluated against a declared value (but passing in the
requirement of drop test); or/and

b) brimful capacity .

As these requirements do not have a bearing on the quality of the container and/or the product
for considering GOL, the applicant shall be advised to submit corrective actions and offer
improved sample of container for independent testing.

In such cases, if the applicant establishes through documentary evidence that the
improved container samples are procured from the same supplier and are made from
the same source and type of raw material as the container sample earlier offered for
independent testing during the preliminary/verification visit and submits the supplier's
certificate of conformity to IS 15410, then GOL may be considered based on the conformity
of the improved container to the requirements of wall thickness and/or brimful capacity, as
the case may be, through independent testing.
 Amendment No.1 to PDW Manual Doc No.SM/IS 14543 & IS 13428/03, JULY 2013

Clause 4.10 - add the following text after Note 1

Note 2 - There may be cases when the sample of container drawn during the preliminary
inspection or verification visit (under simplified procedure), before GOL, is found to be
failing in ONLY the requirements of:

a) wall thickness which is evaluated against a declared value (but passing in the
requirement of drop test); or/and

b) brimful capacity .

As these requirements do not have a bearing on the quality of the container and/or the product
for considering GOL, the applicant shall be advised to submit corrective actions and offer
improved sample of container for independent testing.

In such cases, if the applicant establishes through documentary evidence that the improved
container samples are procured from the same supplier and are made from the same source and
type of raw material as the container sample earlier offered for independent testing during the
preliminary/verification visit and submits the supplier's certificate of conformity to IS 15410, then
GOL may be considered based on the conformity of the improved container to the requirements of
wall thickness and/or brimful capacity, as the case may be, through independent testing.