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

Technical specifications

ReNu SU Technology cartridge
Min. flow rate2 L/min
Max. flow rate 20 L/min
Min. flow rate120 L/h
Max. flow rate1200 L/h
Operating temperature range 5 °C to 37 °C
Pump typeCased 
Connection3/4" TC 
Bore size8.8 mm
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 
CertificationISO 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 

ReNu SU Technology cartridge dimensions

  Component Material
1 Quantum track liner HDPE (USPVI)
2 Quantum tube element Polyurethane
3 Label, Product Paper
4 Quantum manifold HDPE (USPVI)
5 Quantum end cap HDPE (USPVI)
6 Magnet Neodymium, N35SH
7 Quantum cover plate HDPE (USPVI)
8 Label, end cap Paper
9 Quantum collet/joiner Nylon 66
Aseptic connector Dimension A (mm)
Kleenpak Presto Sterile Connector, 3/4" TC 313.0
Readymate Disposable Aseptic Connector, 3/4" TC 313.0
AseptiQuik G Genderless Connector, 3/4" TC 277.5
Cartridge only (no connectors) 195.0

Materials of construction - Cartridge assemblies and connection kits

Component Material
Biopure Pt Silicone single braided hose Platinum cured braid-reinforced silicone hose
BioBarb 5/8" Mini Polypropylene
Q-Clamp Tamper Evident Cover, Yellow Polypropylene
Q-Clamp, 1/2" - 3/4" TC Glass Reinforced Nylon
Sanitary Gasket, 3/4" Unflanged Silicone
BioEndCap Polypropylene
Kleenpak Presto Sterile Connector, 3/4" TC See manufacturers data - Pall (PSC1G08)
Readymate Disposable Aseptic Connector, 3/4" TC See manufacturers data - GE (28-9366-95)
AseptiQuik G Genderless Connector, 3/4" TC See manufacturers data - CPC (AQG33012)

Validation

About the Quantum ReNu validation guides

ReNu SU Technology and its raw materials have been tested under a range of pharmacopoeial and non-pharmacopoeial standards. These include:

  • USP Biocompatibility in vivo and in vitro
  • European Pharmacopoeia, 3.1.9
  • ISO 10993

Additional testing carried out includes extractables testing. For a summary of the validation/qualification testing that has been carried out on ReNu Su Technology, please view the summary guide.

The full validation guide including additional information regarding test methods and actual test reports.

ReNu SU Technology, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances are available in the ReNu SU Technology compliance guide, which can be requested below.

Download summary guide

Sterile ReNu SU Technology cartridge validation summary guide

Validation summary guide PDF - 367kb

Request full validation guide

Disclaimer: You hereby agree the provided validation guide is for private use only to assist in the qualification of the products listed within the validation guide.

You also agree that you will not copy, redistribute, transmit, assign, sell, broadcast, rent, share, lend, modify, adapt, edit or transfer the validation guide to any other party without prior consent from WMFTS.

Disclaimer: You hereby agree the provided validation guide is for private use only to assist in the qualification of the products listed within the validation guide.

You also agree that you will not copy, redistribute, transmit, assign, sell, broadcast, rent, share, lend, modify, adapt, edit or transfer the validation guide to any other party without prior consent from WMFTS.

Literature

Brochures

  1. ReNu sterility cartridge (US).pdf
    PDF - 272kb

Datasheet

  1. ReNu sterility datasheet (EN).pdf
    PDF - 351.3kb

Order Information

Product codes

ReNu SU Technology cartridge product codes

ReNu SU Cartridge Product Codes - RENU SU CARTRIDGE 600 20/3P

Partcode Description Additional details End termination
33-1061-000001 RENU SU CARTRIDGE 600 20/3P Not gamma irradiated 2 x 3/4" TC sealed with Bioendcap
33-1061-000002 RENU SU CARTRIDGE 600 20/3P, IRRADIATED Gamma irradiated and released based on an exposure of 25 kGy to 45 kGY
33-1062-000002 RENU SU 600 20/3P GAMMA WITH PRESTO IN/OUT-STR Gamma irradiated at 25kGy to 45kGy and certified (SAL) level of 1 x 10-6 CFU 2 x Kleenpak Presto Sterile Connector, 3/4" TC (PSC1G08)
33-1062-000003 RENU SU 600 20/3P GAMMA WITH READYMATE IN/OUT-STR Gamma irradiated at 25kGy to 45kGy and certified (SAL) level of 1 x 10-6 CFU 2 x Readymate Disposable Aseptic Connector, 3/4" TC (28-9366-95)
33-1062-000004 RENU SU 600 20/3P GAMMA WITH ASEPTIQUIK G IN/OUT-STR Gamma irradiated at 25kGy to 45kGy and certified (SAL) level of 1 x 10-6 CFU 2 x AseptiQuik G Genderless Connector, 3/4" TC (AQG33012)
  1. This assembly has been gamma irradiated and released based on an exposure of 25 kGy to 45 kGy.
  2. A sterilisation validation study has been conducted according to the ISO11137-2, Method VDmax25 to verify that that a master assembly will meet a sterility assurance level (SAL) of 10-6, when irradiated to a minimum of 25 kGy. This product has been released on the basis of being a section of the master assembly validation study.
  3. Installation recommendations— Avoid sharp bends in pipework. Recommended minimum exit hose length is 2 meters.

STR Denotes that this product is supplied with sterility assurance

 

ReNu SU Technology Product Codes - Cartridge Assemblies

Partcode Description Assembly tubing length Additional details End termination
33-1063-000001 RENU SU 600 20/3P GAMMA ASEPTIQUIK G IN/OUT, 0.5/0.5 MTR STR 0.5m (x2) Gamma irradiated at 25kGy to 45kGy and certified (SAL) level of 1 x 10-6 CFU 2 x AseptiQuik G Genderless Connector, 3/4” TC (AQG33012
33-1063-000002 RENU SU 600 20/3P GAMMA ASEPTIQUIK G IN/OUT, 1.0/1.0 MTR STR 1.0m (x2) Gamma irradiated at 25kGy to 45kGy and certified (SAL) level of 1 x 10-6 CFU
33-1063-000003 RENU SU 600 20/3P GAMMA ASEPTIQUIK G IN/OUT, 2.0/2.0 MTR  STR 2.0m (x2) Gamma irradiated at 25kGy to 45kGy and certified (SAL) level of 1 x 10-6 CFU
33-1063-000004 RENU SU 600 20/3P GAMMA ASEPTIQUIK G IN/OUT, 3.0/3.0 MTR  STR 3.0m (x2) Gamma irradiated at 25kGy to 45kGy and certified (SAL) level of 1 x 10-6 CFU

 

ReNu SU Connection Kit Product Codes

Partcode Description Assembly tubing length Additional details End termination
33-1069-000001 RENU SU CONNECTION KIT, BRAID TUBING, 3/4” TC, 0.5 MTR-NON 0.5m NA 2 x 3/4 TC sealed with Bioendcap
33-1069-000002 RENU SU CONNECTION KIT, BRAID TUBING, 3/4” TC, 1 MTR-NON 1.0m NA
33-1069-000003 RENU SU CONNECTION KIT, BRAID TUBING, 3/4” TC, 3 MTR-NON 3.0m NA
33-1069-000004 RENU SU CONNECTION KIT, BRAID TUBING, 3/4” TC, 2 MTR-NON 2.0m NA
Kits comprise of:
1 x tubing (Biopure 15.9mm ID Pt Silicone single braided hose) ends terminated with BioBarb™ 5/8’’ Mini.
Fittings (supplied loose):
2 x Q-Clamp Tamper Evident Cover, Yellow
2 x Q-Clamp, 1/2” - 3/4” TC
2 x Sanitary Gasket, 3/4” Unflanged
Packing/Sterility details: All components are manufactured and assembled in ISO 14644 class 7 (class 10,000, Grade C) cleanrooms of production facilities operating ISO 9001 quality management systems. The cleanrooms are air conditioned to ensure temperature and humidity.

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