Bioprene - Thermoplastic tubing

Production

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 and USP, 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.

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.

Packaging

Bioprene tubing is double-packed, in heat-sealed polythene bags in the cleanroom. The bags are labeled 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 reels are packed in a card box outside the cleanroom. The card boxes are labeled 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 download a copy of certificate of conformance for Watson-Marlow sanitary tubing and sanitary tubing elements. The raw material is manufactured under strict controls of ingredients, operating procedures and packaging.

All tubing packaging is labeled 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.

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 labeling 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
• Competitive pricing

*Reel length varies with tube size