Pumpheads

Sterile ReNu SU Technology cartridge

Overview

Make sterile connections in non-sterile environments

Plug and play with our ReNu SU (single-use) Technology cartridge assemblies, provided with aseptic connectors and sterility assurance claim.

Sterile ReNu SU Technology cartridge

Sterile ReNu SU Technology cartridge assemblies guarantee quick and secure fluid path connections. These products are released based on a VDmax25 study as detailed by ANSI/AAMI/ISO 11137 guidelines, to provide a sterility assurance level (SAL) of 10-6 when irradiated to a minimum of 25 kGY.

Standard ReNu SU cartridge assemblies include a range of aseptic connectors which enable sterile connections to be made in controlled non-classified spaces.

  • Options of industry recognised aseptic connectors from CPC, PALL and GE
  • ISO Class 7 cleanroom manufactured and packaged assemblies with lot traceability on every component

ReNu SU Technology cartridges are fully manufactured in ISO Class 7 cleanrooms and are suitable for gamma irradiation at up to 50 kGy. ReNu SU Technology cartridges are supplied with an industry-leading validation guide. The guide includes a comprehensive set of biocompatibility data with material tests such as USP88, Class VI (in vivo) and USP87 (in vitro). Detailed extractable testing with a range of solvents in line with BPOG and BPSA guidelines has also been undertaken. The validation guide supports your validation process, reducing your overall time to market.

The secure and consistent positioning of the ReNu SU Technology cartridge in the pumphead—clamped firmly in place at its manifolds—guarantees a secure connection every time. Additionally, each cartridge is supplied with a quick change kit comprising of clamps, gaskets and end caps all designed to keep the time it takes to replace a cartridge to a minimum.

Connection kits are also available consisting of braid reinforced silicone hose configured to customers’ requirements with BioBarb fittings. All components are manufactured in ISO Class 7 cleanrooms.

Single-use fluid path

The synergy between peristaltic pumps and single-use pump systems cannot be overstated. The ReNu SU Technology cartridge slides effortlessly into position allowing for a change of fluid path in minutes whilst eliminating alignment errors.

Features and benefits

  • Choose from a range of industry-standard aseptic connectors
  • Maintain batch integrity
  • Assemblies available with 10⁻⁶ sterility assurance level
  • Maximise manufacturing flexibility and eliminate operator error
  • Suitable for use with the Quantum pump
  • Pressures up to 3 bar and flows up to 20 L/min

Technical summary

Min. flow rate2 L/min
Max. flow rate 20 L/min
Min. flow rate120 L/h
Max. flow rate1200 L/h
Pump typeCased 

Specifications

Validation

Literature

Order Information

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