Overview
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
Pumpsil typical values
- Colour/transparency Translucent
- Spallation Low
- Certification USP Class VI, FDA regulations 21 CFR 177.2600 for contact with food.
- ISO 10993-1
- European Pharmacopoeia 3.1.9
- Sterilization methods Gamma, autoclave, EtO
- Operating temperature -20C to 80C
- Available in thirty different bore sizes, five wall thicknesses and three coil lengths including bulk reels
Request a Pumpsil tubing validation pack
Download Pumpsil EC1935 Declaration Certificate
Validation
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 download the Pumpsil validation summary guide
The full validation guide including additional information regarding test methods and actual test reports is available on request by submitting a validation request form
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 and is available on request by filling in the form found here
Pumpsil additionally complies with the legal regulations laid down in the Regulation (EC) No. 1935/2004. The declaration of compliance can be found here
Also available is a downloadable copy of your certificate of conformance for Watson-Marlow sanitary tubing and sanitary tubing elements.