Skip to main content
oringy.sk

Applications

Pharmaceutical & medical

For reactors, sterilization processes, and medical devices we recommend USP Class VI certified compounds. VMQ and FFKM are standard for single-use applications.

Recommended materials

VMQ, FFKM, EPDM

Pharmaceutical O-rings must have USP Class VI, be ADI-free, and come with batch-traceable documentation. For plasma sterilization and 134 °C autoclaving, FFKM or VMQ is required. Batch traceability is mandatory.

Featured products for this industry

View recommended products

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 USP 87/88 (cytotoxicity) and an extractables/leachables report — we supply all of it with the material.
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, also the polymer maker'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.

Related articles