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Category: Filter Sterilization Validations

Nelson Laboratories, Inc. specializes in testing to help you validate your sterile filtration process.  We can design a comprehensive validation package which can include microbial retention testing using your product, product specific integrity testing, compatibility testing, and filter extractable testing.  We also have the capability to perform specialized filtration studies which can include mycoplasma, yeast or endotoxin filtration.  The validations are performed in compliance with the PDA Technical Report 26, FDA (Guide on Sterile Drug Products Produced by Aseptic Processing), and ISO 13408-2

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Tests available for Filter Sterilization Validations