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Platinum-cured silicone braided hose

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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

Certification and compliance	ADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <95>, USP <97>, USP Class VI
Shelf life	5 years
Gamma stability	Max 50kGy
Autoclave stability	Yes

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
Bore size	3.2 - 25.4 mm
Bore size	0.125 - 1 in
External diameter	8.8 - 34.5 mm
External diameter	0.345 - 1.36 in
Length	7.6 - 15.2 m
Length	25 - 50 Ft
Certification and compliance	ADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <95>, USP <97>, USP Class VI
Operating temperature range	-65 to 254 °C
Operating temperature range	-85 to 490 °F
Burst pressure	15.1 - 48.3 bar
Burst pressure	220 - 700 psi
Shelf life	5 years
Gamma stability	Max 50kGy
Autoclave stability	Yes
Bend radius	25.4 - 101.6 mm
Bend radius	1 - 4 in

Materials of construction

Inner tube	Platinum-cured silicone
Braid layer 1	Polyester
Outer tube	Platinum-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

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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 WMFTS.

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.

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Literature

Brochures

BioPure overview (US).pdf
PDF - 2.4mb

Datasheet

Platinum-Cured Silicone Braided Hoses datasheet (US).pdf
PDF - 161.7kb

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)