I recently spoke with a colleague about visualization of the air in a compliant USP <800> secondary engineering control. He expressed concerns about the inherent nature of a negatively pressured room. While I am very much aware of the issues that CAN occur with this situation, it can be overcome. However, it’s at great cost and very careful daily processes and procedures in place. Even if implemented properly, there’s still a major concern from a microbiological standpoint. This speaks strongly for improving processes and procedures across the board in ALL facilities that have negatively pressured areas for compliance with USP <800>.
Toward the end of the conversation I decided to just film what the air flows look like in my (positively pressured) anteroom which is adjacent to my negative pressure buffer room. Let me just preface this with the idea of contamination CONTROL and prevention. You cannot CLEAN your way out of poor processes and procedures (gowning, aseptic technique, flow of materials, amount of materials in cleanroom, cleanliness of AIR & areas directly outside of cleanroom – For us this was key).
Remember: any movement inside a room will have an effect on the air. Operators must use caution and move slowly and with purpose whether they’re inside a positive or negatively pressured area. Good policies, procedures and practice MUST be exercised regardless, but in particular inside and surrounding a negatively pressured area.