Complete Contamination Control begins with the understanding that it is not our lack of efficacious solutions applied to surfaces or our lack of cleaning techniques. True contamination control starts with understanding the meaning of “War at the DoorTM.” This phrase symbolizes our critical need for the control of contamination from the exterior environment (outside world and our unclassified areas) to our classified areas. This requires a firm to control contamination from the exterior and uncontrolled areas by means of strategic packaging (like the ABCD Cleanroom Introduction System® by VAI, and/or cleaning/disinfecting of items entering prior to the Controlled Not Classified areas). This system continues in each classification from the next level of Grade D (ISO 8) to Grade C (ISO 7) and finally to Grade A/B (ISO 5).
Once a firm places controls for the introduction of contamination in place, particulate and bioburden levels will naturally be reduced. But it won’t be perfect. So through one’s environmental monitoring program, one can develop a listing of routine isolates that are seen in the environment. In short, things the control system missed. Such contamination, may it be particulate or more notably in GMP operations, bioburden, should then be identified to a genus and subsequent species level.
Now that the routinely seen isolates have been identified, a GMP firm, in search of regulatory compliance, should conduct Antimicrobial Effectiveness Testing to assure the appropriate validated demise of the bioburden from the agents we have chosen. This should be done on varying facility surfaces where we would expect the organism to reside and incorporate a multitude of contact (dry) times to accommodate varying application scenarios.
This AET Validation information will provide the framework to choose sanitizers, disinfectants, sporicides, cleaners, cleaning tools, sponges, mops, wipers, gowning and enable us to write SOP’s and train personnel.
At this juncture personnel gowning in all classifications needs to be evaluated, SOP’s written, personnel trained and qualified. Personnel may be one of the main sources of contamination, however, a company with a continued personnel gowning contamination problem is a company that is in drastic need of reevaluation of practices. Gowning products and systems in present day with appropriate training and routine qualifications should be capable of removing this contamination source from the scope of concern.
Once a firm accomplishes the above, one can compliantly conduct “In-Situ” field studies whereby a dirtied room is monitored (environmental monitoring done at a higher than
normal level), and cleaned with the appropriate validated agent using approved SOP’s and trained personnel. And then subsequently monitored again. This validation exercise is noted in regulatory guidelines (ex. 2004 FDA Aseptic Processing Guide) and tells a GMP firm whether what they have validated in really working and/or where problematic situation could and may arise.
Simultaneously, Clean-in-Place (CIP), Clean Out of Place (COP) systems also need to be validated, followed by validation of Steam-in Place (SIP) systems. This assures that product contact surfaces have been appropriately cleaned and validated as sterile.
Once a firm accomplished the above, many firms need to understand that they have potentially looked at their internal operations, systems and validation for so long that the words, systems, and practices may all be blurred. In short, we need another outside set of eyes. And at this juncture, it is prudent to utilize an outside consultant to evaluate and recommend how the system may be improved.
VAI has developed not only products but also services that can assist in all phases of the above process. We have developed over many years a complete contamination control system, that incorporates ex-industry personnel and ex-regulatory personnel. We’ve lived, every day for 40 years, the subject of contamination control and how it is best done. And as a multitude of firms worldwide have experienced, having VAI as part of the team is an invaluable experience.