Fluid path - gaskets

Silicone 5000 series gaskets

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 typeUnflanged 
Certification and complianceADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <95>, USP <97>, USP Class VI 
Shelf life5 years
Gamma stabilityMax 50 kGy 

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

Specifications

Technical specifications

Small Silicone 5000 GasketsStandard Silicone 5000 Gaskets
Gasket typeUnflanged Unflanged 
Internal diameter10.9 - 16 mm22.9 - 147.8 mm
Internal diameter0.43 - 0.63 in0.9 - 5.82 in
External diameter21.6 mm50.3 - 165.4 mm
External diameter0.85 in1.98 - 6.51 in
Size0.5, 0.75 in1, 1.5, 2, 2.5, 3, 4, 6 in
Quantity25 PCS25 PCS
Certification and complianceADCF, 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 life5 years5 years
Gamma stabilityMax 50 kGy Max 50 kGy 

Materials of construction

MaterialPlatinum-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.

Download summary guide

Silicone 5000 series gaskets validation summary guide

Validation summary guide PDF - 393.3kb

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 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.

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.

Literature

Brochures

  1. BioPure overview (US).pdf
    PDF - 2.4mb

Datasheet

  1. Standard Silicone 5000 Gaskets datasheet (US).pdf
    PDF - 445.9kb
  2. Small Silicone 5000 Gaskets datasheet (US).pdf
    PDF - 438.8kb

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

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