Fluid path - transfer hose and tubing

Platinum-cured silicone braided hose

Overview

Platinum-cured silicone braided hose

High pressure flexible braided hose with continuously extruded Platinum-cured silicone core ensures product integrity while delivering increased pressure capability.

BioPure’s Platinum-cured silicone braided hose is supported by an industry leading validation package, meeting current industry requirements including ISO 10993: Parts 5, 6, 10, and 11, USP <88> and USP <87>.

The braided hose has also been evaluated for extractables using a multi solvent approach to BPOG guidelines. Quality management systems of the production facilities are certified to ISO9001.

Features and benefits

  • Manufactured and packed within an ISO 14644 Class 7 cleanroom
  • Post sterilized validation to current USP, EU and FDA standards
  • Withstands sterilization and repeat autoclave
  • Available in either 7.6 m and 15.2 m coils

Technical summary

Shelf life5 years
Gamma stabilityMax 50kGy 
Autoclave stabilityYes 

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

Specifications

Technical specifications

Platinum-cured silicone braided hose
Autoclave stabilityYes 
CertificationADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <95>, USP <97>, USP Class VI 
Gamma stabilityMax 50kGy 
Shelf life5 years
Bend radius1 - 4 in
Bend radius25.4 - 101.6 mm
Bore size0.125 - 1 in
Bore size3.2 - 25.4 mm
Burst pressure15.1 - 48.3 bar
Burst pressure220 - 700 psi
External diameter0.345 - 1.36 in
External diameter8.8 - 34.5 mm
Length25 - 50 Ft
Length7.6 - 15.2 m
Operating temperature range -65 to 254°C
Operating temperature range -85 to 490 °F

Materials of construction

MaterialPlatinum-cured silicone
Inner tubePlatinum-cured silicone
Braid layer 1Polyester
Outer tubePlatinum-cured silicone

Validation

About the Platinum-cured silicone braided hose validation guides

BioPure high pressure braided hose 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 Additional testing carried out includes extractables testing.

For a summary of the validation/qualification testing that has been carried out on BioPure high pressure braided hose, please download the high pressure braided hose validation summary guide.

The full validation guide including additional information regarding test methods and actual test reports is available on request by submitting a validation request form. BioPure high pressure braided hose, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances can be found in the compliance guide and is available on request by filling in the form.

Validation summary guide

The summary guide summarizes the validation/qualification testing that has been carried out on Platinum-cured silicone braided hose.

View Braided hose summary guide [File size] - 306.8kb

Request full validation guide

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. BioPure overview (US).pdf
    PDF - 598.8kb

Datasheet

  1. BioPure braided hose datasheet (EN).pdf
    PDF - 112.9kb

Compliance

Production facilities:

• Components are manufactured and packed within an ISO14644 Class 7 cleanroom Post sterilized product is tested to comply with a range of current USP, EP and FDA standards. These include:

 

• USP <85> to determine the presence of bacterial endotoxin

• USP <88> and ISO 10993 Parts 6, 10 and 11 In vivo for biological reactivity

• USP <87> and ISO 10993 Part 5 for In vitro cytotoxicity

• USP <788> to determine the presence of particulates due to the manufacturing process

• EP 3.1.9 for physiochemical properties

• Extractables studies have been performed using a multi-solvent approach to BPOG guidelines

Order Information

Product codes

Platinum-cured silicone braided hose product codes

Part number I.D. mm (inch) O.D. mm (inch) Length m (ft) Min. bend radius mm (inch) Min. burst pressure at 20C/68F bar (psi)
BPSHP0125-C 3.2 (0.125) 8.8 (0.345) 7.6 (25) 25.4 (1.00) 48.3 (700)
BPSHP0188-C 4.8 (0.187) 10.3 (0.407) 7.6 (25) 31.8 (1.25) 44.3 (650)
BPSHP0250-C 6.4 (0.250) 12.4 (0.490) 7.6 (25) 38.0 (1.5) 43.1 (625)
BPSHP0375-C 9.6 (0.375) 16.7 (0.658) 7.6 (25) 44.4 (1.75) 37.9 (550)
BPSHP0500-C 12.7 (0.500) 20.3 (0.800) 7.6 (25) 50.8 (2.00) 34.5 (500)
BPSHP0625-C 15.9 (0.625) 24.5 (0.965) 7.6 (25) 63.5 (2.5) 28.9 (420)
BPSHP0750-C 19.0 (0.750) 27.9 (1.100) 7.6 (25) 76.2 (3.00) 24.1 (350)
BPSHP0875-C 22.2 (0.875) 32.0 (1.260) 7.6 (25) 88.9 (3.50) 20.7 (300)
BPSHP1000-C 25.4 (1.00) 34.5 (1.360) 7.6 (25) 101.6 (4.00) 15.1 (220)
BPSHP0125-D 3.2 (0.125) 8.8 (0.345) 15.2 (50) 25.4 (1.00) 48.3 (700)
BPSHP0188-D 4.8 (0.187) 10.3 (0.407) 15.2 (50) 31.8 (1.25) 44.3 (650)
BPSHP0250-D 6.4 (0.250) 12.4 (0.490) 15.2 (50) 38.0 (1.5) 43.1 (625)
BPSHP0375-D 9.6 (0.375) 16.7 (0.658) 15.2 (50) 44.4 (1.75) 37.9 (550)
BPSHP0500-D 12.7 (0.500) 20.3 (0.800) 15.2 (50) 50.8 (2.00) 34.5 (500)
BPSHP0625-D 15.9 (0.625) 24.5 (0.965) 15.2 (50) 63.5 (2.5) 28.9 (420)
BPSHP0750-D 19.0 (0.750) 27.9 (1.100) 15.2 (50) 76.2 (3.00) 24.1 (350)
BPSHP0875-D 22.2 (0.875) 32.0 (1.260) 15.2 (50) 88.9 (3.50) 20.7 (300)
BPSHP1000-D 25.4 (1.00)) 34.5 (1.360) 15.2 (50) 101.6 (4.00) 15.1 (220)

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