Bioprene - Thermoplastic Elastomer Tube
From Watson-Marlow Tubing
Bioprene thermoplastic elastomer tube is fully approved for food and pharmaceutical applications. Bioprene lasts at least ten times as long as other tubing materials, thereby reducing stoppages for tube changes. Ideal for high pressure applications with excellent chemical resistance.
Fully documented biocompatibility and comprehensive validation pack.
- Colour/transparency Beige/opaque
- Spallation Low
- Certification FDA regulations 21 CFR177.2600 for contact with aqueous food
- Sterilisation methods Gamma, autoclave, EtO, CIP,SIP
- Operating temperature 5C to 80C
- Available in 27 different bore sizes, five wall thicknesses and three coil lengths including bulk reels.
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 facility.
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 ISO10993-1, and a DMF (Device Master File) has been established with the US FDA.
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 clean room. 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 500feet (152m) of tubing, are also available for 1.6, 2.4 and 3.2mm wall tubing.
The bagged Bioprene 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 Bioprene part number, lot number, use-by date and tube description. A lot-specific certificate of conformance is included with each pack of tubing.
All 800 series tubing is packed in cut lengths in a plastic sleeve in the clean room.
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.
All tubing packaging is labelled with the product description, part and lot numbers, use-by date and a barcode. Included in the box is the certificate of analysis.
As part of the Watson-Marlow ISO9001:2000 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
- 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 feet (152m)'* reels, ideal for higher volume applications
- 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