Event Date/Time: Apr 24, 2009
After initial qualification, few water systems remain unchanged for long. Old seals need to be replaced, valves begin to leak and need to be replaced or refurbished, pumps eventually fail and must be replaced, outlets need to be added or removed, loops need to be expanded, water production capacity needs to be increased, and so forth. All these changes have the capability of compromising the validated state of the water system, so they must be carefully executed and the changes assessed for impact, i.e. qualified. A major system revalidation is often an unnecessary over-reaction to minor changes mandated by well-meaning folks who don't understand the microbiological risks of the proposed changes.
When overly conservative validation or change control departments take this stance, needed maintenance and component replacements tend to be put off and may eventually become major system or even product compromising issues. By the opposite token, looser change control programs may rely on the judgment of utility personnel who don't understand the microbiological risks as to what kinds of changes are minor and may not require any kind of qualification and minimal, if any, change documentation. Both extremes are highly undesirable, so this presentation focuses when such changes truly require a major or minor qualification effort and when it is safe to use the water again through a better understanding of quality specifications and process control levels, as well as the microbiology of water systems.