puresu® - single-use manifold assemblies
Controlled, Efficient, Flexible, Reliable
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Controlled, Efficient, Flexible, Reliable
Drawing on considerable single-use expertise, we offer a broad range of validated components and configurations, with simple, repeatable ordering to support a continuous supply chain.
Full traceability of each component is maintained throughout our single-use assembly process, and is provided as part of our detailed documentation. This ensures your single-use assemblies reach you ready-to-use and that they meet the exacting requirements set by cGMP manufacture and validation guidelines.
BioPure's puresu capability provides:
Assemblies are available in non-irradiated, gamma irradiated and sterile versions (validated in compliance with ANSI/AAMI/ISO 11137 VDmax 25 methodology).
Controlled
Assembled in an ISO Class 7 clean room following cGMP methodology with defined SOP for a consistent product.
Flexible
WMFTS work with you to design an assembly suitable for your processing needs using a combination of internal manufacturing capability and open architecture approach.
Quality
ISO 9001 quality management system, USP <88> Class VI Biological Reactivity, USP <87> In Vitro Cytotoxicity
We carry core components in stock to allow us to respond quickly and ensure that lead times are kept to a minimum.
We have consolidated our documentation to ensure that you only receive what is suitable for bioprocess industry compliance.
Assemblies are provided with an irradiation certificate. Full product certification and validation is available on request.
Sterile tube assemblies available with a 10-6 SAL according to ANSI/AAMI/ISO 11137 VDmax study.
Single-use assemblies
Plug and play ReNu SU (single-use) cartridge assemblies, provided with aseptic connectors and sterility assurance claim.
Pumpheads
Pumps for use in the biotech and pharmaceutical sector