- Model XL - Weldable Biopharmaceutical Tubing

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This pure thermoplastic elastomer can be welded and heat-sealed, allowing complete fluid paths to be assembled in minutes without connectors. PureWeld XL is a high quality peristaltic pump tube which exhibits very low internal spallation and is Animal-Derived Content Free (ADCF).

  • Full biocompatibility and comprehensive validation pack
  • Colour/transparency opaque
  • Spallation very low
  • Certification USP Class VI, FDA regulations 21 CFR177.1810 for contact with food
  •  USP85, USP661, USP788
  • Sterilization methods gamma, autoclave, EtO
  • Operating temperature  -20C to 80C
  • Available in 13 different bore sizes, and four wall thicknesses

  • Meets or exceeds USP Class VI requirements
  • Meets or exceeds ISO10993-1 requirements
  • Meets or exceeds FDA regulations CFR177.1810 for contact with foods
  • Meets or exceeds USP Class VI requirements
  • Animal-Derived Contents Free (ADCF)
  • Detailed validation pack available

Watson-Marlow PureWeld XL tubing is a high purity product which is produced in a state-of-the-art ISO14644-1 Class 7 facility. PureWeld XL is a thermoplastic elastomer tube which is produced from synthetic components. PureWeld XL does not include any natural rubber products such as latex and is animal derived content free. There are no known carcinogens used in the tubing or in the production of the tubing. The raw material has been fully tested to USP Class VI and FDA CFR177.1810.

Watson-Marlow PureWeld XL tubing is manufactured from virgin pellet only, no regrind is used in the production. The raw material is manufactured under strict controls of ingredients, operating procedure and packaging. Each lot of raw material undergoes mechanical testing to ensure compliance with the material specification. Full traceability is assured through the lot number of the tubing, this enables the raw material, manufacturing equipment, quality control records and production records to be identified.

PureWeld XL tubing is double-packed in heat-sealed polythene bags in the ISO14644-1 Class 7 clean room. The bags are labelled with the PureWeld XL part number, lot number, use-by date and tube description. The standard coil length is 15m/50', other coil lengths or cut lengths are available on request.

Tubing reels, which include up to 500'/152m of tubing, are also available for 1.6, 2.4 and 3.2mm wall tubing.

The bagged PureWeld XL coils and reels are packed in a card box outside the clean room. The card boxes are, like the polythene bags, labelled with the PureWeld XL 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 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 Biprene tubing is retained for reference.

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