Water is a critical ingredient widely used in the pharmaceutical industry for the processing, formulation, and production of pharmaceuticals. Due to an increase of micro-organisms in water during distribution, purification and storage; constant control of microbiological quality, inorganic and organic impurities in water are critical.
Revalidation of purified water systems is an essential part of the validation process. It increases the smoothness of the process while ensuring high-quality production of water. Revalidation is crucial and can occur due to various conditions.
A. Periodic revalidation
B. Revalidation after any change
B. Revalidation after any Change: Changes in a purified water system is a phenomenon that cannot be predicted. A simple system breakdown, major dent, an accident etc. can lead to a major overhaul of systems. This means tampering with the coordination which automatically adds contaminations. This is where revalidation comes in. it should be done after any change that affects product/system quality. Perceptible changes include:
1. Change in the procedure due to a revolution in technology.
2. Any physical change in process equipment i.e. change of a manual system to an automatic system.
3. Change in utility used or production system as a major change.
4. Any maintenance work due to the breakdown in the purified water production or distribution system.
5. Expansion of the distribution system and the addition of new user point(s).
Related: How to Remove Pathogens from Water Systems
Unlike validation, revalidation requires less or no time for monitoring and observation. Instead, after any major change revalidation should commence immediately considering the sensitivity of the pharmaceutical industry. Products manufactured in these industries affect all people in their day to day lives. They will be distributed to hospitals, emergency situations, food industry etc.
Related: Biofilm and Its Formation in Water System
Revalidation is not necessary when any equipment is upgraded to a newer version or is replaced with the same type of equipment.
Revalidation of purified water systems is an essential part of the validation process. It increases the smoothness of the process while ensuring high-quality production of water. Revalidation is crucial and can occur due to various conditions.
A. Periodic revalidation
B. Revalidation after any change
B. Revalidation after any Change: Changes in a purified water system is a phenomenon that cannot be predicted. A simple system breakdown, major dent, an accident etc. can lead to a major overhaul of systems. This means tampering with the coordination which automatically adds contaminations. This is where revalidation comes in. it should be done after any change that affects product/system quality. Perceptible changes include:
1. Change in the procedure due to a revolution in technology.
2. Any physical change in process equipment i.e. change of a manual system to an automatic system.
3. Change in utility used or production system as a major change.
4. Any maintenance work due to the breakdown in the purified water production or distribution system.
5. Expansion of the distribution system and the addition of new user point(s).
Related: How to Remove Pathogens from Water Systems
Unlike validation, revalidation requires less or no time for monitoring and observation. Instead, after any major change revalidation should commence immediately considering the sensitivity of the pharmaceutical industry. Products manufactured in these industries affect all people in their day to day lives. They will be distributed to hospitals, emergency situations, food industry etc.
Related: Biofilm and Its Formation in Water System
Revalidation is not necessary when any equipment is upgraded to a newer version or is replaced with the same type of equipment.
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Greetings. If any water system distribution line expand the loop/sub-loop and add a new user point on that sub-loop, is it mandatory to validate the whole system (three phase) again? would you please share any guideline reference for this?
ReplyDeleteYes but not for all three seasons require.
DeleteIf a new deep tube well installed just near previous deep tube well,and used to supply potable water to purified water plant, is it mandatory to validate the whole system again?
ReplyDeleteYes, because source of water is changed.
DeleteIs it necessary to have Loop for Potable water?
ReplyDeleteYes it is a mandatory requirement for water system.
DeleteCan You give me information about biological indicators for autoclave validation and how it use????
ReplyDeleteI have written on the said topic please search.
Deletecan you give me some advices how can i remove Pseudomona aeruginosa which is detected in Softer for many time?
ReplyDelete