Quantum single-use bioprocessing pumps
Flow rates from 5.33 ml/min to 20 L/min (virtually pulsation free). Precise 4,000:1 speed control range.
Pumps - cased pumps
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 rate | 2 L/min |
| Max. flow rate | 20 L/min |
| Min. flow rate | 120 L/h |
| Max. flow rate | 1200 L/h |
| Pump type | Cased |
Specifications
Technical specifications
| ReNu SU Technology cartridge | |
|---|---|
| Min. flow rate | 2 L/min |
| Max. flow rate | 20 L/min |
| Min. flow rate | 120 L/h |
| Max. flow rate | 1200 L/h |
| Operating temperature range | 5 °C to 37 °C |
| Pump type | Cased |
| Connection | 3/4" TC |
| Bore size | 8.8 mm |
| Shelf life | 2 years |
| Static pressure limit | Do not exceed 6 Bar |
| Total cartridge volume | 139 ml |
| Wetted surface area | Total area = 416 cm², Tubing (polyurethane) = 297 cm², Manifolds (HDPE USP VI) = 119 cm² |
| Priming | Self priming |
| Certification and compliance | ISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-6, USP <788>, USP <85>, USP <87>, USP <88> |
| BSE/TSE safe | Yes, compliant with EMEA 410/01 Rev 3 |
| Tube gas Q permeability for oxygen | 21 m²/(sPa)x10⁻¹⁸ |
| Traceability | All material fully traceable back to raw materials |
| Dry running time | Do 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
| Pumphead body assembly | Anodised aluminium |
| Pumphead track | Anodised aluminium |
| Pumphead roller assembly | Stainless steel 316 |
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 - 367kbLiterature
Brochures
-
ReNu sterility cartridge (EN).pdf
PDF - 273.1kb
Datasheet
-
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) |
- This assembly has been gamma irradiated and released based on an exposure of 25 kGy to 45 kGy.
- 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.
- 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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