Pharmaceutical Grade O-Rings
Industry-specific sealing solutions
Overview
Pharmaceutical manufacturing demands the highest standard of sealing material purity, traceability and regulatory documentation. O-rings in drug manufacturing, bioreactor systems, sterile filling lines and chromatography equipment must meet USP Class VI biocompatibility testing, provide full extractables/leachables documentation and withstand repeated steam sterilisation (SIP) or autoclaving.
Our pharmaceutical grade O-rings are supplied with full material traceability, compound certificates, USP Class VI compliance documentation and lot-specific test reports. Silicone and EPDM are the primary materials for pharma service; PTFE is specified for the highest chemical purity requirements.
Recommended Materials
Silicone USP Class VI
Bioreactors, sterile fluid transfer, filling machines, autoclavable equipment
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PTFE Virgin
High-purity process seals, aggressive solvent handling, zero-extractables requirement
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Typical Applications
- Bioreactor seals
- Sterile process seals
- Aseptic filling seals
- Autoclave door seals
- Freeze dryer seals
- HVAC cleanroom seals
- Fluid transfer system seals
- API manufacturing seals
Relevant Standards
Frequently Asked Questions - Pharmaceutical
What is USP Class VI testing for O-rings?
USP Class VI is a biocompatibility test standard from the United States Pharmacopeia. It evaluates materials for systemic toxicity, intracutaneous reactivity and implantation response. Passing USP Class VI indicates the material is suitable for pharmaceutical and medical device contact applications.
Can silicone O-rings withstand SIP (Steam-in-Place) sterilisation?
Yes. USP Class VI silicone withstands repeated SIP cycles at 121°C and 134°C. Compression set resistance is important for maintaining sealing force after multiple sterilisation cycles — specify low-compression-set silicone compounds for SIP service.
Do you provide extractables and leachables documentation?
Yes. We can provide extractables/leachables data for pharmaceutical-grade VMQ and EPDM compounds. Contact us with your regulatory requirements and we will confirm available documentation.