Fluid path - gaskets

Silicone 5000 series gaskets

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Overview

High purity platinum-cured silicone gaskets – 5000 series

Manufactured and packed within an ISO 14644-1 Class 7 cleanroom, these high purity silicone gaskets are ideally suited for bioprocessing fluid paths. Demonstrating comprehensive knowledge of the materials involved in packaging components, the 5000 series gaskets have a low extractable profile. They are also gamma stable for irradiation up to 50 kGY, and autoclavable.

Product validation performed on post gamma-irradiated gaskets.

Extractable studies have been performed using a multi-solvent approach to BPOG guidelines.

Features and benefits

Laser etched lot numbering for full material traceability (non laser-etched version also available)
Designed in accordance with ASME-BPE standards
USP Class VI compliant and animal derived component free (ADCF)
Compliant with FDA regulations CFR 21 177.2600
Gamma stable and autoclavable
Low extractable profile
Double-bagged and heat-sealed

Technical summary

Gasket type	Unflanged
Certification	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 50 kGy

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

Specifications

Technical specifications

	Small Silicone 5000 Gaskets	Standard Silicone 5000 Gaskets
Gasket type	Unflanged	Unflanged
Internal diameter	10.9 - 16 mm	22.9 - 147.8 mm
Internal diameter	0.43 - 0.63 in	0.9 - 5.82 in
External diameter	21.6 mm	50.3 - 165.4 mm
External diameter	0.85 in	1.98 - 6.51 in
Size	0.5, 0.75 in	1, 1.5, 2, 2.5, 3, 4, 6 in
Quantity	25 PCS	25 PCS
Certification	ADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <95>, USP <97>, USP Class VI	ADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <95>, USP <97>, USP Class VI
Operating temperature range	-55 °C to 210 °C	-55 °C to 210 °C
Operating temperature range	-67 °F to 410 °F	-67 °F to 410 °F
Shelf life	5 years	5 years
Gamma stability	Max 50 kGy	Max 50 kGy

Materials of construction

Material

Platinum-cured silicone

Validation

About the Platinum-cured silicone gaskets validation guides

The 5000 series platinum-cured silicone gaskets 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 the 5000 series silicone gaskets, please download the high purity gasket 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 purity gaskets (5000 series silicone only), 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 validation request form.

Validation summary guide

The summary guide summarises the validation/qualification testing that has been carried out on Platinum-cured silicone gaskets.

View Silicone gaskets summary guide - 393.3kb

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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.

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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.

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Literature

Brochures

BioPure overview (EN).pdf
PDF - 863.8kb

Datasheet

Small Silicone 5000 Gaskets datasheet (EN).pdf
PDF - 451.7kb
Standard Silicone 5000 Gaskets datasheet (EN).pdf
PDF - 458.7kb

Order Information

Product codes

Small Silicone 5000 Gaskets product codes

BioPure High Purity Platinum-Cured Silicone Gasket—Laser Etched
Part number	Size inch	O.D inch (A)	I.D inch (B)	Quantity
5001.0050.025	1/2	0.85 (21.6)	0.43 (10.9)	25
5001.0075.025	3/4	0.85 (21.6)	0.63 (16.0)	25

BioPure High Purity Platinum-Cured Silicone Gasket
Part number	Size inch	O.D inch (A)	I.D inch (B)	Quantity
5201.0050.025	1/2	0.85 (21.6)	0.43 (10.9)	25
5201.0075.025	3/4	0.85 (21.6)	0.63 (16.0)	25

Standard Silicone 5000 Gaskets product codes

BioPure High Purity Platinum-Cured Silicone Gasket—Laser Etched
Part number	Size inch	O.D inch (A)	I.D inch (B)	Quantity
5001.0100.025	1	1.98 (50.3)	0.90 (22.9)	25
5001.0150.025	1 1/2	1.98 (50.3)	1.40 (35.6)	25
5001.0200.025	2	2.52 (64.0)	1.90 (48.3)	25
5001.0250.025	2 1/2	3.05 (77.5)	2.40 (61.0)	25
5001.0300.025	3	3.58 (90.9)	2.90 (73.7)	25
5001.0400.025	4	4.68 (118.9)	3.87 (98.3)	25
5001.0600.025	6	6.51 (165.4)	5.82 (147.8)	25

BioPure High Purity Platinum-Cured Silicone Gasket
Part number	Size inch	O.D inch (A)	I.D inch (B)	Quantity
5201.0100.025	1	1.98 (50.3)	0.90 (22.9)	25
5201.0150.025	1 1/2	1.98 (50.3)	1.40 (35.6)	25
5201.0200.025	2	2.52 (64.0)	1.90 (48.3)	25
5201.0250.025	2 1/2	3.05 (77.5)	2.40 (61.0)	25
5201.0300.025	3	3.58 (90.9)	2.90 (73.7)	25
5201.0400.025	4	4.68 (118.9)	3.87 (98.3)	25
5201.0600.025	6	6.51 (165.4)	5.82 (147.8)	25