Bioprene peristaltic pump tubing is USP Class VI and FDA compliant and suitable for biopharmaceutical and food applications. Ideal for critical processes requiring accurate, reliable and repeatable performance.
Bioprene's exceptionally long peristaltic life ensures process security, thereby reducing risk in critical cGMP applications. Bioprene is widely applicable in biopharmaceutical manufacturing operations such as metering, transfer and filtration, along with a variety of applications within the food and beverage industry.
Certification: USP Class VI and FDA regulation 21CFR 177:2600 for contact with aqueous food
Sterilisable by gamma irradiation and autoclaving
Available as standard in 15 different bore sizes, five wall thicknesses and three coil lengths, including bulk reels and LoadSure elements. Other sizes available on request.
Operating temperature: 5C to 80C
Watson-Marlow Bioprene tubing:
Meets USP Class VI requirements
Meets ISO10993 requirements including ISO10993-10
Meets FDA regulations 21 CFR177.2600 for contact with aqueous foods
Watson-Marlow Bioprene tubing is a high purity product which is produced in a state-of-the-art ISO 14644-1 Class 7 cleanroom facility according to cGMP principles operating an ISO9001:2008 quality system. The final tubing product is compliant with USP Class VI, including USP<87> and USP<88>, and FDA 177:2600 for contact with aqueous food. A DMF (Drug Master File) has also been established with the US FDA.
Bioprene is a thermoplastic elastomer tube which is produced from synthetic components. No natural rubber (such as latex) is used in the production of Bioprene tubing. The raw material has been fully tested to USP Class VI and conforms to NSF51.
The raw material is manufactured under strict controls of ingredients, operating procedures and packaging. Watson-Marlow Bioprene tubing is manufactured from virgin pellet only: no regrind is used in the production of Bioprene. Full traceability is assured through the lot number of the tubing, which enables the raw material, primary manufacturing equipment, quality control records and production records to be identified.
Bioprene tubing is double-packed, in heat-sealed polythene bags in the cleanroom. The bags are labelled with the Bioprene part number, lot number, use-by date and tube description. The standard coil length is 50 feet (15m), other coil lengths or cut lengths are available on request.
Tubing reels, which include up to 500 feet (152m) of tubing, are also available for 1.6, 2.4 and 3.2mm wall tubing.
The bagged Bioprene coils and reels are packed in a card box outside the cleanroom. The card boxes are labelled with the Bioprene 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 retained samples. Also available is a downloadable copy of your certificate of conformance for Watson-Marlow sanitary tubing and sanitary tubing elements.
All tubing packaging is labelled with the product description, part and lot numbers, use-by date and a barcode of this information. Included in the box is the certificate of conformance.
As part of the Watson-Marlow ISO9001:2008 system, lot records and process data are stored for all tubing produced in the plant.
Full lot traceability to raw material supply is therefore assured. All records are kept for the shelf life of the tubing. The plastic packaging used in direct contact with the tubing is also lot traceable and, as with the tubing, all lot records are kept for the shelf life of the tubing.
A sample of every production batch of Bioprene tubing is retained for reference.
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 Bioprene 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
Tubing on 500 feet (152m)'* reels, ideal for higher volume applications
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
Custom labelling ensures your part numbers are included on all packaging
We can provide custom sizes and packaging, and guaranteed response times, delivered on time, every time
*Reel length varies with tube size