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Applications

Pharmaceutical & medical

For reactors, sterilization processes, and medical devices we recommend USP Class VI certified compounds. Platinum-cured VMQ and TPE are standard for single-use applications; FFKM is used in reusable critical equipment.

Recommended materials

VMQ, FFKM, EPDM

Pharmaceutical O-rings must have USP Class VI, be ADI-free, and come with batch-traceable documentation. For repeated steam autoclaving at 134 °C, peroxide-cured EPDM or a steam-grade FFKM is the standard choice; VMQ is only of limited suitability for repeated steam. For plasma sterilization, choose FFKM. Batch traceability is mandatory.

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Frequently asked questions about this industry

What does USP Class VI mean and when do I need it?
USP Class VI is a US biocompatibility test (tissue-contact reactivity and injection tests). It is required for contact with drug product, WFI water, and in medical devices. For critical applications, combine it with the USP <87> cytotoxicity test and an extractables/leachables report — the availability of documentation depends on the specific compound.
EPDM, VMQ, or FFKM for a 134 °C autoclave?
Peroxide-cured EPDM withstands hundreds of cycles at 134 °C and is affordable. Silicone (VMQ) has the widest temperature range and excellent physiological harmlessness. FFKM is the most resistant (including to aggressive cleaning media) but costs considerably more — choose it for critical contact with API or solvents.
What documentation do I need for validation of the O-rings?
The minimum is a material compliance declaration (USP, EU GMP), a batch certificate (CoC), and an extractables/leachables report. For FDA-regulated processes, you also need the polymer manufacturer's DMF (Drug Master File). Batch traceability is mandatory — we supply all documents in a single package.
Do you supply O-rings in cleanroom packaging?
Yes — for sensitive applications we pack in a double PE layer in a controlled environment, and on request gamma-sterilized with a sterilization certificate. State the cleanliness class and sterilization method and we will tailor the packaging and documentation.

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