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Qualification of Water System

This document discusses the importance of high quality water in pharmaceutical manufacturing. It outlines various types of water used in different applications and their characteristics. The key water treatment processes used to achieve the required quality are described, including dechlorination, filtration, ultrafiltration, softening, demineralization, reverse osmosis, UV treatment, deionization and ozonization. A three-phase validation approach is recommended to prove the reliability and robustness of water systems, including investigation, verification and continuous verification phases over extended periods. Special precautions for controlling microbial proliferation in loop systems are also noted. Overall, water supply systems must be properly designed and treated to consistently produce water that meets predefined quality parameters.

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665 views15 pages

Qualification of Water System

This document discusses the importance of high quality water in pharmaceutical manufacturing. It outlines various types of water used in different applications and their characteristics. The key water treatment processes used to achieve the required quality are described, including dechlorination, filtration, ultrafiltration, softening, demineralization, reverse osmosis, UV treatment, deionization and ozonization. A three-phase validation approach is recommended to prove the reliability and robustness of water systems, including investigation, verification and continuous verification phases over extended periods. Special precautions for controlling microbial proliferation in loop systems are also noted. Overall, water supply systems must be properly designed and treated to consistently produce water that meets predefined quality parameters.

Uploaded by

abdul qudoos
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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PREPARED BY: RIZWAN NAQVI

 High-quality water is essential for the manufacturing


of pharmaceuticals. Water is the most commonly used
raw material in pharmaceutical manufacturing.
 Water is directly & indirectly used in pharmaceutical
manufacturing such as a major component in
injectable products and in cleaning of manufacturing
equipments.
Quality of water should be specific for product quality.

Water contains,
 Organic &In-organic impurities
 Microbial contamination
 Endotoxin
 Particulate contamination

Low quality of water can lead to,


 Product degradation
 Product contamination
 Loss of product and profit
 Each type has its own characteristics for all parameters
 Potable Water
 Purified water
 Water for injection (WFI)
 Sterile water for Injection,
inhalation
 Sterile bacteriostatic water for injection
 De-chlorination (Sodium Bisulphite, carbon filter)
 Filtration
 Ultra Filtration
 Softening
 Demineralization
 Reverse Osmosis
 UV Treatment
 Deionization
 Ozonization
 To prove the performance,
one must demonstrate
(document) that the processes
or systems consistently produce
the specified quantity and quality of water when operated and
maintained according to specific written operating and
maintenance procedure.
 Validation involves proving
1- Engineering design
2- Operating procedures & acceptable range for control parameters
3- Maintenance procedures to accomplish it the system must be carefully,
 Designed
 Installed
 To ensure reliable, consistent
production of water of require
quality.
 To prevent unacceptable microbial,
chemical & physical contamination
during production, storage & distribution.
 Always considered direct impact system
 To monitor system performance & operate system
within design capacity
 Three phase approach recommended according to
WHO TRS 929 t o prove reliability and robustness.
 Phase 1 (Investigation)
 Phase 2 (Verification )
 Phase 3 (Continuous Verification)
 Extended reliable performance
 Seasonal Variations
 A test period of 2-4 weeks,
monitor the system
 System to operate continuously
without failure or performance
deviation
 Chemical & microbiological testing should include in
accordance with a define plan.
 Water can not be used for manufacturing purposes
during this phase
 A further test period of 2-4 weeks,
further intensive monitoring of the system
 Utilization of all the SOPs after the satisfactory
completion of phase 1
 Water can be used for manufacturing purposes during
this phase.
 Chemical & microbiological testing should include in
accordance with a define plan.
 Over 1 year after the satisfactory
completion of phase 2.
 This is final phase to demonstrate
that;
 Extended reliable performance
 Seasonal Variations
 Water can be used for manufacturing purposes during this
phase
 Sample locations, sampling frequencies & tests should be
reduced to the normal routine pattern based on
established procedures proven during phase 1 & phase 2.
 System in place to control proliferation of microbes
 Techniques for sanitizing or sterilization
 Special precautions if water not kept in the range of 70
to 80°C in loop system.
 Minimize dead legs
 Clean joints
 Water supply Systems
 Play a major role in the quality of products
 Must be designed properly.
 Water treatment system must be designed in such a
way that it produces the required quality of water that
meets the predefined parameters as set by the user

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