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Single-use assemblies for pre-use post-sterilization integrity testing (PUPSIT) for final filling in bioprocessing applications comply with PUPSIT requirements and ensure downstream sterility.
Parker´s PureTain® PUPSIT (pre-use and post-use integrity testing) filtration assemblies are designed for single-use bioprocessing where the product cannot be terminally sterilized and requires sterile filtration in the final downstream process steps.
They combine the benefits of both filtration and single-use tube sets to provide a pre-assembled, fully enclosed and sterile plug-and-play PUPSIT solution – where the sterile filters can be fully integrity tested without risking any contamination of the fluid path in the final downstream process.
As per the latest UE GMP Annex 1, PUPSIT is now a default requirement for manufacturers who cannot terminally sterilize their product in its final container, and therefore, need to employ sterile filtration.
Designed with compliance to these revised regulations, Parker’s PUPSIT single-use assemblies can be customized to fit process needs with a range of options around tubing, filtration, sampling and connectability to meet the specific needs of your process.
Features and Benefits:
• Pre-sterilized and ready to use
• Fully enclosed fluid pathway
• Customizable to suit process requirements
• Available as a standalone assembly, or as part of an automated solution
Parker’s global single-use team can assist in the design, validation, qualification and implementation of your single-use solution, calling upon our expertise in filtration, single-use systems, sensing and automation.
Please contact your local Parker representative to discuss how these systems can be configured for your needs.
Literature and Reference Materials |
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Report: Single-Use Systems: Overcoming challenges and mitigating risk in bioprocessing |
Productos |
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