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Although BioProcess Containers (BPCs) undergo quality testing at the manufacturer’s facility, improper handling and loading procedures can introduce flaws during shipping, storage, and unpacking.
The inSITE Integrity Testing System is a true point-of-use integrity testing system that allows users in a biopharmaceutical manufacturing environment to confirm the integrity of single-use BPCs. Using sterile air, the inSITE system can help detect gross and fine flaws at a very critical time—immediately prior to BPC filling. Multi-channel features enables conduct testing on multiple BPCs simultaneously—additionally, manifolds and assemblies can be tested. Regardless of geographical location, the inSITE system can be utilized without concern of region-specific electrical requirements.
Although stringent standards—such as raw material inspections, in-process pressure decay testing, sealing validations, and packaging and shipping procedures—are maintained for all products, there is potential for damage after the product leaves the facility, specifically during BPC handling and placement. At the critical stage of fluid filling, the inSITE system offers a level of confidence to biopharmaceutical manufacturers by helping to ensure that their product will enter a viable BPC.
Although stringent standards—such as raw material inspections, in-process pressure decay testing, sealing validations, and packaging and shipping procedures—are maintained for all products, there is potential for damage after the product leaves the facility, specifically during BPC handling and placement. At the critical stage of fluid filling, the inSITE system offers a level of confidence to biopharmaceutical manufacturers by helping to ensure that their product will enter a viable BPC.
Available in standard or custom configurations, covering a range of applications, sizes, and connection systems.
Outer support containers are designed for storage, collection, harvest and other processes.
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