Tubing - peristaltic

Pumpsil platinum-cured silicone tubing

Overview

Pumpsil platinum-cured silicone tubing

Developed for the biopharmaceutical industry, Pumpsil is exceptionally pure tubing offering an ultra-smooth bore which helps minimize protein binding and ensure high purity in the finished product.

Pumpsil is widely used for single-use biopharm applications, as well as pH control and media feed in fermentation, accurate metering, transfer and filtration. Absolute traceability with laser-etched part number, lot number and use-by-date. Fully documented biocompatibility and comprehensive validation pack.

Chemical Compatibility Guide

Features and benefits

  • Fully documented biocompatibility and comprehensive validation pack
  • Absolute traceability with laseretched part number, lot number and use-by date
  • Excellent flow stability for accurate process control
  • Comprehensive stock of a wide range of sizes
  • Operating temperature -4 °F to 176 °F

Technical summary

SpallationLow 
CertificationFDA 21CFR177.2600, Ph. Eur. 3.1.9, Regulation (EC) No 1935/2004, USP Class VI 
Operating temperature range-20 - 80 °C
Operating temperature range-4 - 176 °F
Shelf life5 years
Gamma stability25-50 kGy 
Autoclave stability121 °C 30 minutes 

Technical Summary table lists features available within the range. See ‘Technical specifications’ tab for model specific information.

Specifications

Technical specifications

Bore size0.5 - 25.4 mm
Bore size0.02 - 1 in
Wall thickness1.4 - 4.8 mm
Wall thickness0.0625 - 0.1875 in
Length3 - 152 m
ColorColorless 
TransparencyTranslucent 
SpallationLow 
Life reference313/314 pumpheads - 230 hours, 520R pumpheads - 200 hours, 620R pumpheads - 230 hours 
CertificationFDA 21CFR177.2600, Ph. Eur. 3.1.9, Regulation (EC) No 1935/2004, USP Class VI 
Operating temperature range-20 - 80 °C
Operating temperature range-4 - 176 °F
Hardness, shore A (5sec)60 
Specific gravity1.16 g/ml
UV resistance Excellent 
Tear B200-500 ppi
Ultimate tensile strength90.05 bar
Ultimate tensile strength1306 psi
Elongation at break550-1500 %
Tensile stress at 100% elongation118 Psi
Gas permeability ratingLow 
Compression set5-42.5 %
Water absorptionLow 
Shelf life5 years
Gamma stability25-50kGy 
Autoclave stability121 °C 30 minutes 
Sterilisation methodsAutoclave, EtO, Gamma 
Weight0.1 - 10.7 kg
Weight0.22 - 23.59 lbs
Compatible pumpheads313D, 313D2, 314D, 314D2, 520R, 520R2, 620R, 720R 

Materials of construction

Tubing MaterialPlatinum-cured silicone

Validation

About the Pumpsil tubing validation guides

Pumpsil and its raw materials have been tested under a range of pharmacopoeial and non pharmacopoeial standards. These include:

  • USP Biocompatibility in vivo and in vitro
  • European Pharmacopoeia, 3.1.9
  • ISO 10993
  • EC 1935/2004

Additional testing carried out includes extractables testing. For a summary of the validation/qualification testing that has been carried out on Pumpsil, please see the summary guide.

The full validation guide including additional information regarding test methods and actual test reports.

Pumpsil, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances can be found in the Pumpsil compliance guide which can be requested below.

Pumpsil additionally complies with the legal regulations laid down in the Regulation (EC) No. 1935/2004.

Pumpsil declaration of compliance

Certificate of conformance

Validation summary guide

The summary guide summarizes the validation/qualification testing that has been carried out on Pumpsil platinum-cured silicone tubing.

View Pumpsil tubing summary guide - 477kb

Request full validation guide

What type of guide(s) do you require?

Disclaimer: You hereby agree the provided validation guide is for private use only to assist in the qualification of the products listed within the validation guide.

You also agree that you will not copy, redistribute, transmit, assign, sell, broadcast, rent, share, lend, modify, adapt, edit or transfer the validation guide to any other party without prior consent from WMFTG.

Literature

Brochures

  1. Biopharm tubing (US).pdf
    PDF - 2.3mb
  2. Tubing overview (EN).pdf
    PDF - 659.4kb

Datasheet

  1. Pumpsil datasheet.pdf
    PDF - 237.9kb

Production and packaging

Production

Our custom silicone achieves precision, consistency and durability. The tubing is "addition cured" and is entirely free of the 2,4 DCBA residue associated with peroxide tubing. We built an ISO 14644-1 Class 7 clean room air conditioned to maintain constant temperature and humidity.

Our customers can be sure of a product without impurities. Each stage of manufacture is performed by state-of-the-art production machinery, supervised by highly skilled personnel. We achieve an accuracy which is typically a fraction of the published tolerance. 100% on-line inspection plus off-line checks during every run ensure that all Pumpsil® tubing is validated to the highest standards.

Packaging

Pumpsil tubing is double-packed in heat-sealed polythene bags in the clean room. The polythene bags are, like the Pumpsil tubing, free of any animal derived components. The bag is labeled with the part number, lot number and use-by date and tube description. The standard coil length is 15m (50 feet) 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 Pumpsil coils and the reels are packed in a card box outside the clean room. The card boxes are, like the polythene bags, labeled with the Pumpsil 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 sanitary tubing and sanitary tubing elements.

Traceability

Traceability is fundamental in the biopharm industry, where validated processes must be demonstrated. In response to this vital requirement from our customers, every Watson-Marlow Pumpsil® tube is permanently laser-marked end-to-end with part number, lot number and use-by date. Laser coding produces an indelible print which uses no ink and has no effect on tube performance. It means that, for the first time, lot traceability is carried through from box to bag to the tube itself.

Also available is a downloadable copy of your certificate of conformance for Watson-Marlow sanitary tubing and sanitary tubing elements.

Bulk tubing

If you buy large volumes of silicone 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 ft/152 m reels*, ideal for higher volume applications
  • Custom labeling ensures your part numbers are included on all packaging

Custom Laser Traceability (laser coding on the surface of the tube) ensures that the tubing is identified in the correct way in your process and is fully traceable. For example, laser coding your part number and purchase order guarantees traceability irrespective of whether the tubing has been removed from the packaging or has been used. Unlike some ink-based printing, LaserTraceability cannot be removed by common clean-room solvents such as IPA and will not contaminate your product.

We can provide custom sizes and packaging, and guaranteed response times, delivered on time, every time.

*Reel length varies with tube size

Order Information

Product codes

Tube ordering codes
Bore Wall Coil size
mm inch mm inch 15m/50ft 5m/16ft 152m/500ft
0.5 1/50 1.6 1/16 913.A005.016 913.AJ05.016 913.B005.R16
0.8 1/32 1.6 1/16 913.A008.016 913.AJ08.016 913.B008.R16
1.2 3/64 1.6 1/16 913.A012.016 913.AJ12.016 913.B012.R16
1.6 3/32 1.6 1/16 913.A016.016 913.AJ16.016 913.B016.R16
2.4 1/16 1.6 1/16 913.A024.016 913.AJ24.016 913.B024.R16
3.2 1/8 1.6 1/16 913.A032.016 913.AJ32.016 913.B032.R16
4.8 3/16 1.6 1/16 913.A048.016 913.AJ48.016 913.B048.R16
6.4 1/4 1.6 1/16 913.A064.016 913.AJ64.016 913.B064.R16
122m/400ft
8.0 5/16 1.6 1/16 913.A080.016 913.AJ80.016 913.B080.R16
152m/500ft
0.5 1/50 2.4 3/32 913.A005.024 913.AJ05.024 913.B005.R24
0.8 1/32 2.4 3/32 913.A008.024 913.AJ08.024 913.B008.R24
1.6 1/16 2.4 3/32 913.A016.024 913.AJ16.024 913.B016.R24
3.2 1/8 2.4 3/32 913.A032.024 913.AJ32.024 913.B032.R24
122m/400ft
4.8 3/16 2.4 3/32 913.A048.024 913.AJ48.024 913.B048.R24
91m/300ft
6.4 1/4 2.4 3/32 913.A064.024 913.AJ64.024 913.B064.R24
61m/200ft
8.0 5/16 2.4 3/32 913.A080.024 913.AJ80.024 913.B080.R24
46m/150ft
9.6 3/8 2.4 3/32 913.A096.024 913.AJ96.024 913.B096.R24
3m/10ft 91m/300ft
4.8 3/16 3.2 1/8 913.A048.032 913.A048.I32 913.B048.R32
61m/200ft
6.4 1/4 3.2 1/8 913.A064.032 913.A064.I32 913.B064.R32
46m/150ft
9.6 3/8 3.2 1/8 913.A096.032 913.A096.I32 913.B096.R32
30m/100ft
12.7 1/2 3.2 1/8 913.A127.032 913.A127.I32 913.B127.R32
15.9 5/8 3.2 1/8 913.A159.032 913.A159.I32 -
8.0 5/16 4.0 - 913.A080.040 913.A080.I40 -
12.0 - 4.0 - 913.A120.040 913.A120.I40 -
16.0 - 4.0 - 913.A160.040 913.A160.I40 -
9.6 3/8 4.8 3/16 913.A096.048 913.A096.I48 -
12.7 1/2 4.8 3/16 913.A127.048 913.A127.I48 -
15.9 5/8 4.8 3/16 913.A159.048 913.A159.I48 -
19.0 3/4 4.8 3/16 913.A190.048 913.A190.I48 -
25.4 1 4.8 3/16 913.A254.048 913.A254.I48 -

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