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 

Icons

Specifications

Technical specifications

ReNu SU Technology cartridge
Flow rate2 L/min to 20 L/min
Flow rate120 L/h to 1200 L/h
Operating temperature5 °C to 37 °C (41 °F to 98.6 °F) 
Pump typeCased 
Connection3/4" TC 
Bore size8.8 mm (0.346 in)  
Shelf life2 years
Static pressure limitDo not exceed 6 Bar 
Total cartridge volume139 ml
Wetted surface areaTotal area = 416 cm², Tubing (polyurethane) = 297 cm², Manifolds (HDPE USP VI) = 119 cm² 
PrimingSelf priming 
Certification and complianceISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-6, USP <788>, USP <85>, USP <87>, USP <88> 
BSE/TSE safeYes, compliant with EMEA 410/01 Rev 3 
Tube gas Q permeability for oxygen21 m²/(sPa)x10⁻¹⁸
TraceabilityAll material fully traceable back to raw materials 
Dry running timeDo not exceed 2 mins 
Pumphead body assemblyAnodised aluminium
Pumphead trackAnodised aluminium
Pumphead roller assemblyStainless steel 316

Documentation

Brochures

  1. ReNu sterility cartridge (EN).pdf
    PDF - 273.1kb

Datasheets

  1. ReNu SU Technology cartridge datasheet (EN).pdf
    PDF - 769.1kb

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