Air flow Visualization Study (1)
Contamination control has always been a concern for the manufacturers as well as the regulators of sterile pharmaceutical products. Usually, the transfer of contaminants into a zone protecting a product and/or personnel is prevented by using: (a) Aerodynamic measures, i.e., by arrangement and flow direction, (b) Physical barriers, i.e., by both active and passive isolation, or (c) Combination of both.
Our experience of retrospectively reviewing numerous airflow visualization study videos shot in the different aseptic processing zones/ areas of several sterile pharmaceutical product manufacturing facilities have seldomly revealed any problem with the design and/ or the established controls for ensuring the expected airflows.
If that is the case, then why do the manufacturers get slapped by the regulators is an intriguing question? One of the prime reason we could identify is a failure to explain difference between a normal/ usual/ expected and an abnormal/ unusual/ unexpected airflow pattern for a specific aseptic processing zone/ area.
In this experience and knowledge sharing series, we will try explaining the underlying science as well as myths and realities associated with the air flow visualization study (smoke study).
Controlled Environment Engineer
11 个月I cannot find the next part in this airflow visualisation study. I agree with the premise, you do need to simulate unexpected occurences to prove compliance of a system. For example unauthorised entry to a RABS while production is running, what would be the consequences to maintaining contamination control. I look forward to hearing more on this.