Validation of pharmaceutical water system and pure

steam

Name: Payal Rakeshbhai Patel

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Enrollment no: 201904103910010
Guided By: Dr. Pintu Prajapati.
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Validation of pharmaceutical water

system
3 Introduction:
 Water is the mostly used substances, raw material, or ingredient in production ,
processing and formulation of pharmaceutical product.
 Water is directly or indirectly used in the pharmaceutical manufacturing such as a
major component in injectable products and in cleaning of manufacturing
equipments.
4 Continued…
Quality of water should be specific for product quality
 Water contains,
- Organic and inorganic impurities
- Microbial contamination
- Endotoxin
- Particulate contamination
 Low quality of water can lead to
- Product degradation
- Product contamination
- Loss of product and profit
5 TYPES OF WATER
Different grades of water for pharmaceutical purposes each type has its on
characteristic for all parameters.

 Potable water
 Purified water
 Water for injection(WFI)
 Sterile water for injection, inhalation, irrigation
 Bacteriostatic water for injection
6 Different techniques used for water
treatment
 De-chlorination(Sodium Bisulphite, Carbon Filter)
 Filtration
 Ultra Filtration
 Demineralization
 Reverse Osmosis
 UV Treatment
 Deionization
 Ozonization
 Different equipments and components
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for water system

 Piping
 Valves
 Pumps
 Pressure gauges
 Heat exchangers
 Distillation unit
 Filters
 Deionizers
 Sensors
 Auxiliary equipment
8 Why validation of water system?

 To ensure reliable, consistent production of water of required quality

 To operate system within design capacity
 To prevent unacceptable microbial, chemical and physical contamination during
production, storage and distribution
 To monitor system performance, storage and distribution systems
9 Design qualification

DQ is documented the design of the system & will include:

 Functional specification.( storage, purification, etc. )
 Technical/Performance specification for equipment.(requirements of water
volume and flow, define pumps and pipe sizes)
 Detailed layout of the system.
 Quality attribute of input water
 Required plant output capacity
 Selection of membrane.
 Designing of holding tanks pumps, heat exchangers and piping.
Design must be in compliance with GMPs and other regulatory requirements.
10 Installation qualification
IQ is in the form the checklist and it should include_
 Instrumentation checked against current engineering drawings and specification
 Verification of materials of construction
 Installation of equipment with piping
 Calibration of measuring instruments
 Verification of absence of leak
 Installation of system as per design requirements
 Inspection for pipe slope
 Verification for stainless steel
 Passivation review of documentation of welds
 Documentation include details of completed installation
11 Operational qualification

 The purpose of OQ is to establish, through documented testing, that all critical

components are capable of operating within established limits and tolerance
 The purpose of OQ is also to verify and document that the water supply system
provides acceptable operational control under “at-rest” conditions
Operational qualification to check_
 Ability to provide water of sufficient quality and quantity to ensure achievement
of specifications.
 Ability to maintain general parameters like temperature, pressure, flow at set
points.
 Ability to maintain any critical parameters (pH, endotoxin, microbial levels,
conductivity etc.)
12 Performance qualification

 The purpose of PQ is to verify and document that the water supply system
provides acceptable control under the “full operational” conditions.
 PQ should follow successful completion of IQ and OQ.
 PQ verifies that over time, the critical parameters, as defined in the DQ are being
achieved.
 PQ is used to demonstrate consistent achievement of critical parameters over
time. ( such as pH, TOC, conductivity)
13

Validation of pure steam

14 Introduction

 Pyrogen free, dry, saturated steam that is generally produced by a pure steam
generator and which when condensed shall meet the requirements of WFI is
called as pure steam.
 Pure steam is water that has been heated above 100 degrees Celsius and
vaporized in a manner that prevents source water entrainment.
 Pure steam is mainly used for sterilizing tanks, filters and piping systems, as well
as products in sterilizers.
 Moreover, its used for air-moistening in clean room systems.
15 Types of steam

 In pharmaceutical industry , 2 types of steam are used.

 It includes house steam and clean steam.
 House steam contains steam generator and distribution system made of iron and
steel. It is constructed with rusting material. This system is usually treated with
various substances like amines, hydrazine or other boiler additives to arrest
corrosion.
 Clean steam is established when steam is used directly for treating the product or
product’s contact surfaces. Its constructed with non- rusting material. Eg.,
stainless steel.
16 Installation qualification

 IQ for a steam generator is done according to purchase specifications and the

steps done are as follows:
• Connect the generator to the required utilities and verify on to their correctness
• Clean generator chemically and passivate generator after installation.
• Label the utilities feeding the generator.
• Carry out the pressure testing and record the results.
• Check and calibrate all critical processes instruments.
17 Operational qualification

 The purpose of OQ is to establish , through documented testing, that all critical

components are capable of operating within established limits and tolerances. It’s
the functional testing of system components mainly the critical components.
 OQ for a steam generator is done as SOP and it follows:
• According to SOP , start up and run the clean steam generator. Record normal
operating parameter of the system.
• Check that all instruments and alarms are working correctly. Record their status.
• Check that the generated steam meet the specifications and can be produced in
quantities required.
18 Sampling of pure steam

 Sampling for bacterial endotoxin test and chemical tests should be done
separately.
 De- pyrogenated tubes or bottles should be used for taking sample for bacterial
endotoxin test.
 Allow the steam to drain for minimum one minute. Open the cap of the bottle and
fill the bottle with condensate by holding the bottle in the holder.
 Gloves should be worn while sampling the pure steam.
 Tighten the cap of the bottle and mark with sampling information.
 If the sample is not analyzed within 2 hours of sampling, store the sample at 2-8
degree Celsius.
19 Analysis of pure steam

 Pure steam should be analysed for following tests:

• Non- condensable gases
• Steam dryness value
• pH
• Conductivity
• Microorganisms
• Endotoxin test
20 Performance qualification

 After IQ and OQ comes PQ. The purpose of PQ is to verify and document that steam
system provides acceptable control under ‘full operational’ conditions.
 PQ verifies that over time, the critical parameters are achieved as they are defined.
21 Reference

 http://www.authorstream.com/Presentation/nan29-3276771-validation-pure-steam/
 Jadhav VM, Gholve SB, Kadam VJ. Validation of Pharmaceutical Water system: A review.
Journal of pharmacy research. 2009 May;2(5):948-52.