Pumpsil platinum-cured silicone tubing
Overview
Pumpsil platinum-cured silicone tubing
Developed for the biopharmaceutical industry, Pumpsil is exceptionally pure tubing offering an ultra-smooth bore which helps minimise protein binding and ensure high purity in the finished product.
Pumpsil is widely used for single-use biopharm applications, as well as pH control and media feed in fermentation, accurate metering, transfer and filtration. Absolute traceability with laser-etched part number, lot number and use-by-date. Fully documented biocompatibility and comprehensive validation pack.
Features and benefits
- Fully documented biocompatibility and comprehensive validation pack
- Absolute traceability with laser etched part number, lot number and use-by date
- Excellent flow stability for accurate process control
- Comprehensive stock of a wide range of sizes
- Operating temperature -20 ºC to 80 ºC (-4 ºF to 176 ºF)
Technical summary
| Spallation | Low |
| Certification and compliance | FDA 21CFR177.2600, Ph. Eur. 3.1.9, Regulation (EC) No 1935/2004, USP Class VI |
| Shelf life | 5 years |
| Gamma stability | 25 kGy to 50 kGy |
| Autoclave stability | 121 °C 30 minutes |
Technical Summary table lists features available within the range. See ‘Specifications’ tab for model specific information.
Specifications
Technical specifications
| Pumpsil | |
| Bore size | 0.5 - 25.4 mm (0.02 - 1 in) |
| Wall thickness | 1.6 - 4.8 mm (0.063 - 0.188 in) |
| Length | 3 - 152 m (10 - 500 ft) |
| Colour | Colourless |
| Transparency | Translucent |
| Spallation | Low |
| Certification and compliance | FDA 21CFR177.2600, Ph. Eur. 3.1.9, Regulation (EC) No 1935/2004, USP Class VI |
| Operating temperature | -20 °C to 80 °C (-4 °F to 176 °F) |
| Hardness, shore A (5sec) | 60 |
| Specific gravity | 1.16 g/ml |
| UV resistance | Excellent |
| Tear B | 0.02 - 0.06 kN/m (200-500 ppi) |
| Ultimate tensile strength | 9 Mpa (1306 psi) |
| Elongation at break | 550-1500 % |
| Tensile stress at 100% elongation | 8.13 MPa (1180 psi) |
| Gas permeability rating | Low |
| Compression set | 5-42.5 % |
| Water absorption | Low |
| Shelf life | 5 years |
| Gamma stability | 25 kGy to 50 kGy |
| Autoclave stability | 121 °C 30 minutes |
| Sterilisation methods | Autoclave, EtO, Gamma |
Materials of construction
| Tubing | Platinum-cured silicone |
Validation
About the Pumpsil tubing validation guides
Pumpsil 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
- EC 1935/2004
Additional testing carried out includes extractables testing. For a summary of the validation/qualification testing that has been carried out on Pumpsil, please see the summary guide.
The full validation guide including additional information regarding test methods and actual test reports.
Pumpsil, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances can be found in the Pumpsil compliance guide which can be requested below.
Pumpsil additionally complies with the legal regulations laid down in the Regulation (EC) No. 1935/2004.
Pumpsil declaration of compliance
Certificate of conformance
Download summary guide
Pumpsil platinum-cured silicone tubing validation summary guide
Validation summary guide PDF - 1,3mbDocumentation
Brochures
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Medical devices and diagnostics brochure (EN).pdf
PDF - 1,5mb
Datasheets
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Pumpsil Elements datasheet (EN).pdf
PDF - 224,9kb -
Pumpsil datasheet (EN).pdf
PDF - 234kb
Other Resources
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Food contact Pumpsil tubing DOC.pdf
PDF - 386,6kb
Production and packaging
Production
Our custom silicone achieves precision, consistency and durability. The tubing is "addition cured" and is entirely free of the 2,4 DCBA residue associated with peroxide tubing. We built an ISO 14644-1 Class 7 clean room air conditioned to maintain constant temperature and humidity.
Our customers can be sure of a product without impurities. Each stage of manufacture is performed by state-of-the-art production machinery, supervised by highly skilled personnel. We achieve an accuracy which is typically a fraction of the published tolerance. 100 % on-line inspection plus off-line checks during every run ensure that all Pumpsil® tubing is validated to the highest standards.
Packaging
Pumpsil tubing is double-packed in heat-sealed polythene bags in the clean room. The polythene bags are, like the Pumpsil tubing, free of any animal derived components. The bag is labelled with the part number, lot number and use-by date and tube description. The standard coil length is 15Â m (50Â feet) other coil lengths or cut lengths are available on request.
Tubing reels, which include up to 500 feet (152 m) of tubing, are also available for 1.6 mm, 2.4 mm and 3.2 mm wall tubing.
The bagged Pumpsil coils and the reels are packed in a card box outside the clean room. The card boxes are, like the polythene bags, labelled with the Pumpsil part number, lot number, use-by date and tube description. A lot-specific certificate of conformance is included with each pack of tubing.
Full lot traceability is maintained for every batch of tubing produced through detailed raw material and production records, hard copy and electronic production data and retain samples. Also available is a downloadable copy of your certificate of conformance for Watson-Marlow sanitary tubing and sanitary tubing elements.
Traceability
Traceability is fundamental in the biopharm industry, where validated processes must be demonstrated. In response to this vital requirement from our customers, every Watson-Marlow Pumpsil® tube is permanently laser-marked end-to-end with part number, lot number and use-by date. Laser coding produces an indelible print which uses no ink and has no effect on tube performance. It means that, for the first time, lot traceability is carried through from box to bag to the tube itself.
Also available is a downloadable copy of your certificate of conformance for Watson-Marlow sanitary tubing and sanitary tubing elements.
Custom Laser Traceability (laser coding on the surface of the tube) ensures that the tubing is identified in the correct way in your process and is fully traceable. For example, laser coding your part number and purchase order guarantees traceability irrespective of whether the tubing has been removed from the packaging or has been used. Unlike some ink-based printing, LaserTraceability cannot be removed by common clean-room solvents such as IPA and will not contaminate your product.
Order Information
Product codes
Pumpsil product codes
| Tube ordering codes | ||||||
|---|---|---|---|---|---|---|
| Bore | Wall | Coil size | ||||
| mm | inch | mm | inch | 15m/50ft | 5m/16ft | 152m/500ft |
| 0.5 | 1/50 | 1.6 | 1/16 | 913.A005.016 | 913.AJ05.016 | 913.B005.R16 |
| 0.8 | 1/32 | 1.6 | 1/16 | 913.A008.016 | 913.AJ08.016 | 913.B008.R16 |
| 1.2 | 3/64 | 1.6 | 1/16 | 913.A012.016 | 913.AJ12.016 | 913.B012.R16 |
| 1.6 | 1/16 | 1.6 | 1/16 | 913.A016.016 | 913.AJ16.016 | 913.B016.R16 |
| 2.4 | 3/32 | 1.6 | 1/16 | 913.A024.016 | 913.AJ24.016 | 913.B024.R16 |
| 3.2 | 1/8 | 1.6 | 1/16 | 913.A032.016 | 913.AJ32.016 | 913.B032.R16 |
| 4.8 | 3/16 | 1.6 | 1/16 | 913.A048.016 | 913.AJ48.016 | 913.B048.R16 |
| 6.4 | 1/4 | 1.6 | 1/16 | 913.A064.016 | 913.AJ64.016 | 913.B064.R16 |
| 122m/400ft | ||||||
| 8.0 | 5/16 | 1.6 | 1/16 | 913.A080.016 | 913.AJ80.016 | 913.B080.R16 |
| 152m/500ft | ||||||
| 0.5 | 1/50 | 2.4 | 3/32 | 913.A005.024 | 913.AJ05.024 | 913.B005.R24 |
| 0.8 | 1/32 | 2.4 | 3/32 | 913.A008.024 | 913.AJ08.024 | 913.B008.R24 |
| 1.6 | 1/16 | 2.4 | 3/32 | 913.A016.024 | 913.AJ16.024 | 913.B016.R24 |
| 3.2 | 1/8 | 2.4 | 3/32 | 913.A032.024 | 913.AJ32.024 | 913.B032.R24 |
| 122m/400ft | ||||||
| 4.8 | 3/16 | 2.4 | 3/32 | 913.A048.024 | 913.AJ48.024 | 913.B048.R24 |
| 91m/300ft | ||||||
| 6.4 | 1/4 | 2.4 | 3/32 | 913.A064.024 | 913.AJ64.024 | 913.B064.R24 |
| 61m/200ft | ||||||
| 8.0 | 5/16 | 2.4 | 3/32 | 913.A080.024 | 913.AJ80.024 | 913.B080.R24 |
| 46m/150ft | ||||||
| 9.6 | 3/8 | 2.4 | 3/32 | 913.A096.024 | 913.AJ96.024 | 913.B096.R24 |
| 3m/10ft | 91m/300ft | |||||
| 4.8 | 3/16 | 3.2 | 1/8 | 913.A048.032 | 913.A048.I32 | 913.B048.R32 |
| 61m/200ft | ||||||
| 6.4 | 1/4 | 3.2 | 1/8 | 913.A064.032 | 913.A064.I32 | 913.B064.R32 |
| 46m/150ft | ||||||
| 9.6 | 3/8 | 3.2 | 1/8 | 913.A096.032 | 913.A096.I32 | 913.B096.R32 |
| 30m/100ft | ||||||
| 12.7 | 1/2 | 3.2 | 1/8 | 913.A127.032 | 913.A127.I32 | 913.B127.R32 |
| 15.9 | 5/8 | 3.2 | 1/8 | 913.A159.032 | 913.A159.I32 | - |
| 8.0 | 5/16 | 4.0 | - | 913.A080.040 | 913.A080.I40 | - |
| 12.0 | - | 4.0 | - | 913.A120.040 | 913.A120.I40 | - |
| 16.0 | - | 4.0 | - | 913.A160.040 | 913.A160.I40 | - |
| 9.6 | 3/8 | 4.8 | 3/16 | 913.A096.048 | 913.A096.I48 | - |
| 12.7 | 1/2 | 4.8 | 3/16 | 913.A127.048 | 913.A127.I48 | - |
| 15.9 | 5/8 | 4.8 | 3/16 | 913.A159.048 | 913.A159.I48 | - |
| 19.0 | 3/4 | 4.8 | 3/16 | 913.A190.048 | 913.A190.I48 | - |
| 25.4 | 1 | 4.8 | 3/16 | 913.A254.048 | 913.A254.I48 | - |
Further reading
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Download PDF - 238.3kb
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