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Industry: Pharmaceutical Testing
For the Pharmaceutical industry Nelson specializes in filter validations, facility validation (including disinfectant studies), container integrity studies, preservative effectiveness studies, cleanroom and isolator facilities, antibiotic potency assays, sterilization and packaging validations, and routine quality control tests.
[ more ]Test categories available for Pharmaceutical Testing
Filter Sterilization Validations (1 test set) (4 tests)
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
Package Testing (1 test set)
Nelson Laboratories specializes in package integrity testing and has developed test methods for this testing. The basis forpackge testing is to help the manufacturer in the development and validation of their packaging operations. It is crucial to assure package integrity for sterile medical devices. The methods developed at NLI conform to the standard covered in ISO 11607 "Packaging for terminally sterilized medical devices".