BioPure high purity gaskets

High purity gaskets

High purity gaskets

Contact us

To order this product please contact us on:

Tel: +27 11 796 2960

Fax: +27 11 794 1250

You can also send us an email or find your nearest distributor

Overview

BioPure fluid path components brochure

BioPure fluid path components brochure

Download now

BioPure high purity gaskets

BioPure high purity gaskets

Our sanitary gaskets support leak resistant connectivity within pharmaceutical and biotechnology production processes, reducing validation risks in contamination-free applications.

Each of our high-purity gaskets have been engineered to deliver unparalleled sealing performances under clamping compression. Each product has been manufactured from carefully considered materials to provide durable and robust sealing between mating surfaces, without compromising the integrity of your fluid path.

BioPure gasket materials chart

Silicone 5000 series

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. 

Download platinum-cured silicone gaskets 5000 series datasheet

Silicone RXPX series

High purity platinum-cured silicone gaskets RXPX series

The RXPX series sanitary silicone gaskets are Platinum-cured and suitable for biomanufacturing processes. They are designed to achieve a smooth bore, contamination free fluid path under clamping compression.

Download platinum-cured silicone gaskets RXPX series datasheet

EPDM

EPDM gaskets

(ethylene propylene diene monomer)

EPDM gaskets offer quality performances in sanitary applications with repetitive steam-in-place (SIP) cycles. These sanitary gaskets have been designed to achieve a smooth bore, contamination free fluid path under clamping compression, retaining their geometric stability after repeat SIP cycles. This ensures that your SIP validation is not compromised. 

Additionally, EPDM gaskets do not deform to trap bacteria, or stick, causing the gasket to adhere to a ferrule face. The EPDM material maintains the important conditions of clean, intact removal with no trace of elastomer material finding its way into the fluid process. 

Download EPDM gaskets datasheet

PTFE

PTFE gaskets 

(polytetrafluoroethylene)

PTFE gaskets offer the ultimate chemical resistance and purity. PTFE is almost totally chemically inert, and offers versatility in application due to being highly flexible, strong, and able perform in extreme temperature conditions. 

These high performance sanitary gaskets have been designed to achieve a smooth bore, contamination free fluid path under clamping compression.

Download PTFE gaskets datasheet

PolySteel

PolySteel gaskets

(polytetrafluoroethylene / stainless steel)

These high purity gaskets offer a quality performance in applications that require continuous steam resistance. A 50/50 PTFE/stainless steel composite, designed to dramatically reduce cold flow and creep, Polysteel gaskets maintain their integrity under repeated SIP cycles. They have been constructed for maximum sealability, providing leak proof performance, offering less downtime in plants.

Polysteel gaskets perform in extreme temperature conditions, ranging from -212C to 327C (-350F to 620F ) and come in a range of sizes from ¼ inch to 6 inch.

Download PolySteel gaskets datasheet

Envelope

Envelope gaskets

Envelope gaskets are made from PTFE and are built around the choice of an EPDM or FKM rubber core, improving the gaskets sealing characteristics. They are designed to achieve a smooth bore, contamination free fluid path under clamping compression.

These sanitary gaskets can be exposed to temperature extremes from -212C to 232C (-350F to 450F) and come in a range of sizes from ½ inch to 6 inches.

Download envelope gaskets datasheet

Viton®

Viton® gaskets

(synthetic rubber and fluoropolymer elastomer)

Viton® gaskets deliver an enhanced performance in applications that require heat, acid and chemical resistance. Viton® has a high rubber density, which helps to maintain geometric stability after repeated SIP cycles. 

These sanitary gaskets can be exposed to temperature extremes, ranging from -23C to 204C (-10F to 400F ) and are available both flanged and unflanged in a range of sizes from ½ inch to 6 inches (unflanged) and 1 inch to 6 inches (flanged).

Download viton gaskets datasheet

Viton® is a registered trademark of Chemours Company

Validation

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:

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 form found here.

  • Contact us

    To order this product please contact us on:

    Tel: +27 11 796 2960

    Fax: +27 11 794 1250

    You can also send us an email or find your nearest distributor