Thoughts on the Applicability of Laminar Flow Interference Testing in Clean Areas
In clean area management and quality control, laminar flow interference testing has received much attention, and whether it is only applicable to Class A laminar flow remains to be considered.
Due to high environmental requirements, key process areas are permanently designated as Class A laminar flow. Conducting laminar flow interference testing here is extremely reasonable and crucial. A-level laminar flow requires stable and uniform airflow to protect highly sensitive production processes from external airflow interference. Through testing, it is possible to accurately detect factors such as equipment, personnel, and materials that affect the stability and flow pattern of the lower layer flow. Timely error correction and optimization can be carried out to ensure an ideal production environment and lay a solid foundation for product quality.
The rest of the clean area is mostly turbulent flow, and generally speaking, its airflow interference is smaller than that of A-level laminar flow. Due to its low sensitivity to local changes, slight fluctuations are difficult to cause significant harm to production. Therefore, it cannot be generalized whether to test non A-level turbulent flow areas, and it needs to be determined based on specific circumstances.
In special circumstances, this test should also be considered for non-A-grade areas. When dealing with airflow sensitive materials, even small changes in airflow in turbulent areas may cause material abnormalities and damage product quality; If there are special requirements for airflow in the preparation of special dosage forms, stable airflow is indispensable; When non Class A areas are adjacent to Class A areas and there is a risk of airflow interaction, testing can prevent quality fluctuations and cross contamination. Through testing, potential air flow hazards can be detected early, and measures such as adjusting ventilation parameters and optimizing area layout can be taken to ensure that the clean area environment meets standards and is controllable.
In short, the interference testing of laminar flow patterns in clean areas is not only required for A-level laminar flow, but A-level testing must be emphasized. It should also be comprehensively balanced under non-A-level specific conditions to promote accurate and comprehensive clean area management, safeguard drug production and other processes, and stabilize product quality.
Suzhou Pharma Machinery Co.,Ltd.
2025/04/29
Mia
