Filter Leak Testing in Compounding Pharmacies

Compounding pharmacies prepare custom medications for patients who have needs not met by commercially available products. This may be necessary for medical reasons, such as avoiding a non-active ingredient the patient is allergic to, or to provide an exact dose that isn’t commercially available.

The compounding pharmacy industry does not have the strict regulatory oversight of the pharmaceutical industry, and yet are making drugs and injectable products with high sensitivity to airborne particulates and microbes. The USP <797> practice and cGMP Aseptic Processing guidance instill the importance of following pharmaceutical cleanroom operations and protocols including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

Why is it important to test HEPA filters for leaks?

Cleanrooms use HEPA filtration to limit the concentration of airborne particles and potential contamination, and cGMP recommends testing each HEPA filter in cleanrooms up to twice a year for Class 5 cleanrooms. There is growing pressure for accrediting agencies like state boards of pharmacy to adopt both cGMP and USP <797> practices for hospital pharmacists as well.

How are ATI’s products used?

Whether testing HEPA in-situ or in biosafety cabinets, the HEPA filter integrity test requires portable test equipment to generate and measure the concentration of a challenge aerosol, and then detect the amount of aerosol that leaks through the filtration system.

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