EVALUATION AND MICROBIOLOGICAL INVESTIGATIONS OF RADIATION STERILIZATION OF Re-Usable POLYSULFONE MEMBRANE

One of the most important points in the manufacture of healthcare products is the production of a sterile product with specified (SAL). Healthcare product manufacturers strive to provide safe and sterile products by validating and controlling manufacturing procedures. At present, (SAL) of 10-6 is generally accepted for pharmacopoeia and (FDA). The validation studies can be designed in particular for different types of products. Each product needs distinct protocol for bioburden determination, dose mapping and sterility testing. For microbiological tests, culture condition should be selected in both cases of the bioburden and sterility testing. Bioburden is used to describe the population of viable microorganisms present on or in a product and/or a sterile barrier system. Bioburden estimations are used to indicate possible problems in the production process that can lead to inadequate sterilization, calculate the necessary dose for effective sterilization, and to monitor product to ensure adequate dosing. This study presents some results and practical solutions chosen to perform a sterilization validation, compliant with EN ISO Standards, Pharmacopeia and FDA regulations. In this study gamma radiation was selected to sterilize Polysulfone fibers (Allmed PS, SafeFlow and/or POLYPURE filter). Gamma sterilization validation was performed using method 1 in accordance to EN ISO 11137-1, and EN ISO 11137-2 to achieve (SAL) 10-6. Protocol of gamma sterilization validation was achieved.