Survivor 101: Safe Change Filtration
Safe change filtration was originally designed to handle radiopharmaceuticals for the nuclear market. In more recent times, this technology has been extended and utilized for the handling of most pharmaceutical compounds. Safe change filtration allows the changing of the ULPA or the HEPA filter without exposing the operator, minimizing the risk of contact to any potent and hazardous substance.
The bag-in, bag-out filter housings are equipped with PVC or PE bags to seal the filter-housing during filter replacement. Some systems have gloves sealed into the bags for easier handling of the filter elements. Because of the size of typical bag-in, bag-out systems, they are installed above the clean room in the technical area. The filter housing can be equipped with an automatic filter scanning system to proof the filter tightness.
Equipped with HEPA filters, an isolator is capable of containing the hazardous drugs compounded. HEPA filters then have direct contact and contain high level of hazardous drug concentration. This poses an occupational risk during HEPA filter replacements.
In Esco Pharma, every equipment can be configured to have a safe change filter replacement. Filters of the isolators can be upgraded for example to BIBO.
BIBO Safe Change
It utilizes a Bag-in, Bag-out Filter to safely remove the filter after biodecontamination. It provides protection against exposure for the maintenance personnel and the environment.
Low-Contamination Filter Change
Filter change is done inside the closed isolator, through the glove ports. The used filter is placed in a safety disposal bag and removed from the isolator through the pass chamber. This provides a minimal exposure to the maintenance personnel and environment.
Safe Change Procedure
Facilities shall develop SOPs for safe change of HEPA filters such as wearing of appropriate PPE. The filter should be changed and the scrap filter be placed in a safety disposal bag. However, among the methods for safe filter change, this is the least effective because the only protection you have is the PPE.
