The GMP clean workshop for biopharmaceuticals has strict requirements for air cleanliness, fiber-free condition, and traceability. The selection, installation, and replacement of filters must all comply with GMP standards. The pharmaceutical workshop adopts a multi-level filtration system. At the front end of the air conditioning unit, M5/M6 pre-filters are installed, in the middle section, F7/F8 medium-efficiency bag filters are used, and at the end, H13 high-efficiency box filters are employed. The two front-level filters can intercept most dust and protect the end high-efficiency filters, prolonging their service life. The filter selection requires that the filter material does not shed fibers and the components in contact with the air should not release harmful substances. The product needs to have a complete factory inspection report to facilitate GMP audits. In the high-grade pharmaceutical clean area, double-flange high-efficiency filters are preferred to reduce the risk of frame leakage. The filter replacement operation needs to be carried out after the clean area is shut down and dust is reduced. After the replacement is completed, a PAO leak detection must be performed, and only after the leak detection is qualified can production resume. 

Equipment features: The surface of the filter frame is smooth and flat, not prone to dust accumulation, and easy to clean. The sealing glue is selected from materials that do not have fiber shedding and are resistant to aging. Product testing is based on ISO14644 and GMP clean workshop-related acceptance specifications. The greatest feature of the filter in the pharmaceutical clean workshop is that the entire process is traceable. From the product's factory production, on-site installation, leak detection records to the replacement ledger, all need to be retained and archived to avoid particle and microbial contamination of the pharmaceutical production environment and ensure the compliance of pharmaceutical production.