Peristaltic pump tubing PureWeld® XL

polyvinylidene fluoride

Overview
Designed for secure, cost‑effective peristaltic pumping and transfer duties, PureWeld XL tubing delivers extended service life and accurate flow performance compared with standard TPE tubing. It offers chemical compatibility for a range of bioprocess fluids, is weldable for rapid assembly of fluid paths and features an ultra‑smooth bore and wall engineered to minimise spallation and support ultrasonic flow measurement.

Features and benefits

• Reduces inventory and minimises fluid contact materials
• Full compendial data to USP <788> for sub‑visible particulates
• EP 2.6.14, USP <85> for bacterial endotoxins
• Suitable for sterilisation by gamma irradiation (validated 25–50 kGy)
• Animal‑derived‑content free (ADCF)

Technical summary
Spallation: Very low
Certification and compliance: EC 1935/2004, FDA 21CFR177.1810, USP <661>, USP <788>, USP <85>, USP Class VI
Gamma stability: 25 kGy to 50 kGy

Materials of construction

• Tubing: SEBS (thermoplastic elastomer)
• Connector material (elements): PVDF for sanitary elements where specified

Validation / Compliance summary
PureWeld XL and constituent raw materials have been evaluated against pharmacopoeial and non‑pharmacopoeial standards including USP biocompatibility (in vivo and in vitro), European Pharmacopoeia 3.1.9, ISO 10993 and EC 1935/2004. Additional extractables and validation/qualification testing have been performed; summary guides and validation documentation are available for the range.

Production and packaging
Produced in an ISO14644‑1 Class 7 facility from virgin pellet only (no regrind). Tubing is double‑packed in heat‑sealed polythene bags in the clean room and labelled with part number, lot number, use‑by date and tube description. Standard coil length is 15 m (50 ft); reels up to 152 m (500 ft) are available for selected sizes. A lot‑specific certificate of conformance is included with each pack. Full lot traceability is maintained.

Traceability
All packaging is labelled with product description, part and lot numbers and use‑by date; a certificate of conformance is included. Lot records and process data are retained for the shelf life of the tubing and a sample of every production batch is retained.

Caractéristiques / spécifications techniques

• Bore size range (tube series): 0.5 mm to 25.4 mm (0.02 in to 1 in)
• Wall thickness range: 1.6 mm to 4.8 mm (0.0625 in to 0.1875 in) depending on size
• Available lengths: coils 15 m to 152 m (50 ft to 500 ft) depending on product
• Colour / Transparency: Colourless; opaque appearance for range
• Operating temperature: -20 °C to 80 °C (-4 °F to 176 °F)
• Hardness (Shore A, 5s): 65–73
• Specific gravity: 0.89–0.91 g/cm³
• Tear B: >30 kN/m (>171 ppi)
• Ultimate tensile strength: 8–18 MPa (116–261 psi)
• Elongation at break: >450%
• Tensile stress at 100% elongation: 2.4–3.5 MPa (348–507 psi)
• Gas permeability: Low
• Compression set: <80%
• Water absorption: Low
• Sterilisation method: Gamma (25–50 kGy validated)
• Spallation: Very low (engineered to reduce particulate generation)
• Certifications: EC 1935/2004, FDA 21CFR177.1810, USP <661>, USP <788>, USP <85>, USP Class VI