Report

Document No. QR12001

Version 01
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Performance Qualification Report for

Reverse Osmosis Plant (RO Plant)
Author: Date: Signed by:

Reviewer: Date: Signed by:

Approved by: Date: Signed by:

Replaces No.: Replaces Date: Effective Date :

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1. Purpose
The purpose of this validation report is to ensure the effective performance of
RO water plant to produce highly purified water of pharmaceutical configuration
(Art No. 00877308) complying all the parameters as described in Quality
Specification No. LM57E280 and Protocol No. QPR12001.

2. Scope
This Qualification Report is valid for Reverse Osmosis plant of production /
maintenance Department.

3. Test Equipment
Reverse Osmosis Plant (RO Plant)
Make: Local

4. Location of the Test Equipment

Reverse Osmosis Plant Room
Bayer-Schering Pharma, Lahore Plant.

5. List of Equipments required for qualification

 Chlorine Kit & Reference Charts
 Hardness Kit & Reference Charts
 Conductivity Meter

6. Testing facilities required for qualification

 Chemicals, solutions and laboratory equipments for chemical analysis.
 Total Microbial Count testing facility.

7. Acceptance Criteria
a. All the critical systems should be operating within the tolerance limit of that
particular function.
b. The testing results of purified water being produced should comply all the
physical, chemical and microbiological parameters as described in Quality
Specification No. LM57E280 Version 8.0
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8. Description of Procedure

Schematic flow of RO Water System

a. Charcoal Filtration
Sample of water is taken from Valve SV-01 for analyzing the absence of
Chlorine contents after charcoal filtration. 05 ml of sample is taken and 4 drops
of Merck Cl2-1 Kit are added in it. The sample remained colorless, indicating
that there is no chlorine (0 ppm chlorine) in the sample.

Table No. 1

Results (2011) Proceeded

Test Limit
26/3/12 27/3/12 28/3/12 29/3/12 30/3/12 By
Chlorine
0 ppm 0 ppm 0 ppm 0 ppm 0 ppm 0 ppm
Contents
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b. Water Softening System

Water is then moved to water softening system for removal of magnesium,
calcium, chlorides, nitrates, carbonates and sulphates ions. Water softening
system also removes any particulate material of size > 3.0 µm.

 Sample of water is taken from Valve SV-01 , as there is no separate valve

available up to “after softening system” valve. Sample is taken for analyzing
the absence of magnesium, calcium, chlorides, nitrates, carbonates and
sulphates ions (Hardness) after passing through water softening system. For
this purpose, Merck RH-1 Kit for Hardness testing, Cat No. 1.11142, is used.
05 ml of each sample is taken and 02 drops of RH-1 reagent are added.
Green color appearance of the solution indicates that there is no hardness in
the sample, i.e., 0 ppm Hardness.

Table No. 2

Results (2011) Proceeded

Test Limit
26/3/12 27/3/12 28/3/12 29/3/12 30/3/12 By

Hardness 0 ppm 0 ppm 0 ppm 0 ppm 0 ppm 0 ppm

Color of the solution is matched with color card provided with the kit. Green
coloration of the final sample solution indicates that there is no hardness in the
sample, i.e., 0mg/L or 0ppm.
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c. Removal of Organic Substances after Reverse Osmosis

Softened water is then supplied to reverse osmosis. This system comprises of
double reverse osmosis pattern. At first water is passed through a reverse
osmosis double cartridge system, these two cartridges are working collectively
to reduce the load on single one, water is collected in storage vessel, from
where, it is supplied to 2nd stage of reverse osmosis.

 Sample of water is taken from Valve SV-06 and oxidizable substances are
evaluated in the sample against the limits as described in Quality
Specification No. LM57E280 Version 8.0

Table No. 3

Results (2011) Proceeded

Test Limit
26/3/12 27/3/12 28/3/12 29/3/12 30/3/12 By
The solution
Oxidizable
must remain Complies Complies Complies Complies Complies
Substances
slightly pink

Printouts are attached as Annexure-1, Annexure-2, Annexure-3, Annexure-4 and

Annexure-5 for the days 26-09-11, 27-09-11, 28-09-11, 29-09-11 and 30-09-11
respectively.
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d. De-ionization
After reverse osmosis, the water is supplied to deionization system. This system
comprises of anion and cation resins columns.

 Sample is collected from Valve SV-07 and conductivity is checked as per

Quality Specification No. LM57E280 Version 8.0 for water, purified. Printouts
are attached with this report.

Table No. 4

Results ( µS/cm) Proceeded

Test Limit
26/3/12 27/3/12 28/3/12 29/3/12 30/3/12 By
< 4.3 µS/cm*
Conductivity 0.5 0.3 0.3 0.4 0.4
at 20 oC

Printouts are attached as Annexure-1, Annexure-2, Annexure-3, Annexure-4 and

Annexure-5 for the days 26-09-11, 27-09-11, 28-09-11, 29-09-11 and 30-09-11
respectively.
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e. Final Water after UV Sterilization

Deionized water is then goes to UV Sterilization column and final product water is
produced.

 Sample is collected from Valve SV-10 and all the parameters for purified
water as per Quality Specification No. LM57E280 Version 8.0 are
analyzed.

Table No. 5

Results Proceeded
Test Limit
26/3/12 27/3/12 28/3/12 29/3/12 30/3/12 By

Appearance Clear Colorless Liquid Passes Passes Passes Passes Passes

Conductivity
< 1.1 (µS/cm) at 20 oC 0.5 0.4 0.3 0.5 0.4
(µS/cm)
Nitrates & Color not more intense
Passes Passes Passes Passes Passes
Nitrites than Ref soln.

TOC (mg / Lit) < 0.5 (mg / Lit) 0.3752 0.3329 0.4462 0.3696 0.2168

Color not more intense

Heavy Metals Passes Passes Passes Passes Passes
than Ref soln.
Total
Microbial < 100 cfu / ml 14 3 10 13 1
Count
Test for
Escherichia Absent (per 100ml) Passes Passes Passes Passes Passes
coli
Test for
coliform Absent (per 100ml) Passes Passes Passes Passes Passes
microbes

Printouts are attached as Annexure-1, Annexure-2, Annexure-3, Annexure-4 and

Annexure-5 for the days 26-09-11, 27-09-11, 28-09-11, 29-09-11 and 30-09-11
respectively.
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 Graphical evaluation of conductivity of final RO water (product water).

Graph 1

 Graphical evaluation of Total Organic Carbon of final RO water (product

water).

Graph 2
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 Graphical evaluation of Total Microbial Count of final RO water (product

water).

Graph 2

9. Data Analysis
The parameters monitored during performance qualification of RO water system
are summarized in above mentioned Tables (Table No. 1 to Table No. 5) and
annexes (Annexure-1 to Annexure-5).

Based on these results, findings are as below:

 All the in-process tests performed during qualification of RO water
system are found within respective tolerance limit.
 The “Product Water” meets the requirements as per Quality Specification
No. LM57E280 Version 8.0 for Water, Purified.

10. Conclusion
The results narrated under heading of Data Analysis indicate that existing
settings and procedures meet the acceptance criteria as per Quality
Specification No. LM57E280 Version 8.0
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It is therefore concluded that RO water system is deemed qualified for the

production of purified water for use in washing, final rinsing in solids and
semisolids sections and for production of solids and semisolids dosage forms.

11. Deviation / Observations

 There is no sampling valve available for testing the quality of raw water
(supply water), before carbon filter and after carbon filter.
 Few flow meters / flow meter joints were leaking.
 Chlorination module is not connected with the system.
 The electric cable for some module is fixed at floor, whenever the storage tank
is required to be drained, it will definitely interact with electric cable, and may
cause some serious incident.
 The lid of storage tank has not protection against unnecessary opening.
 It is recommended to provide a valve from base of the storage tank to
evacuate the water completely (when required). At present, the available
valve cannot drain the water completely.

12. Corrective Actions

Maintenance department has been intimated for rectification of problem.

13. Attachments for Final Report

 Annexure-1, 2, 3, 4 & 5 for complete analysis.

14. Reference Documents

 Quality Specification No. LM57E280, Version 8.0 for Water, Purified.

15. Re-Qualification Frequency

 Every Five Years