Technical specifications
| Pumpsil | Pumpsil Elements |
Bore size | 0.5 - 25.4 mm | 0.5 - 25.4 mm |
Bore size | 0.02 - 1 in | 0.02 - 1 in |
Wall thickness | 1.6 - 4.8 mm | 2.4 - 4.8 mm |
Wall thickness | 0.063 - 0.188 in | 0.094 - 0.188 in |
Length | 3 - 152 m | |
Colour | Colourless | Colourless |
Transparency | Translucent | Translucent |
Spallation | Low | Low |
Certification and compliance | FDA 21CFR177.2600, Ph. Eur. 3.1.9, Regulation (EC) No 1935/2004, USP Class VI | FDA 21CFR177.2600, Ph. Eur. 3.1.9, Regulation (EC) No 1935/2004, USP Class VI |
Operating temperature range | -20 °C to 80 °C | -20 °C to 80 °C |
Operating temperature range | -4 °F to 176 °F | -4 °F to 176 °F |
Hardness, shore A (5sec) | 60 | 60 |
Specific gravity | 1.16 g/ml | 1.16 g/ml |
UV resistance | Excellent | Excellent |
Tear B | 0.02 - 0.06 kN/m | 0.02 - 0.06 kN/m |
Tear B | 200-500 ppi | 200-500 ppi |
Ultimate tensile strength | 1306 psi | 1306 psi |
Ultimate tensile strength | 9 MPa | 9 MPa |
Elongation at break | 550-1500 % | 550-1500 % |
Tensile stress at 100% elongation | 8.13 Mpa | 8.13 Mpa |
Tensile stress at 100% elongation | 1180 Psi | 1180 Psi |
Gas permeability rating | Low | Low |
Compression set | 5-42.5 % | 5-42.5 % |
Water absorption | Low | Low |
Shelf life | 5 years | 5 years |
Gamma stability | 25 kGy to 50 kGy | 25 kGy to 50 kGy |
Autoclave stability | 121 °C 30 minutes | 121 °C 30 minutes |
Sterilisation methods | Autoclave, EtO, Gamma | Autoclave, EtO, Gamma |
ASTM methods Hardness: ASTM D 2240; Specific gravity: ASTM D 792; Tear B ISO 34-2; Ultimate tensile strength, Elongation at break, Tensile stress at 100 % elongation ISO 37; compression set ISO 815-1; ASTM D 412
Materials of construction
Tubing | Platinum-cured silicone |
Connector material | Polypropylene, PVDF |
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
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 15 m (50 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 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.
If you buy large volumes of silicone tubing, Watson-Marlow can supply tubing in the way that best suits your production needs.
- Custom tube sizes to suit your specific application
- Custom coil lengths to suit your production requirements
- Competitive pricing
- Custom cut lengths to fit your process, this eliminates on-site cutting and ensures the tubing is ready for use
- Packaging to suit your needs - single bag, double bag, gamma radiation traceable, individually packed cut lengths, bulk packed
- Tubing on 500 ft/152 m reels*, ideal for higher volume applications
- Custom labelling ensures your part numbers are included on all packaging
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.
We can provide custom sizes and packaging, and guaranteed response times, delivered on time, every time.
*Reel length varies with tube size