Medical Sealing Solutions
International Seal supplies precision sealing solutions for medical equipment, bioprocessing systems, pharmaceutical applications and critical healthcare equipment. Our range includes O-rings, gaskets, hygienic seals and custom sealing components selected for cleanliness, material compatibility and reliable performance in demanding life-science environments. FDA-compliant and selected USP Class VI elastomer materials are available, with applicable certification and material documentation available on request.
Seals for Medical Devices & Bioprocessing Equipment
International Seal provides precision engineered sealing components for the medical and life sciences sector. Our products are designed to meet strict regulatory standards while ensuring safety, cleanliness and reliability. Medical sealing places unusual demands on materials: they must resist repeated sterilisation, remain biocompatible in patient contact and hold consistent dimensions at very small sizes. We select compounds and tolerances to suit each of these requirements rather than supplying a generic part.
Medical Inventory
- Sanitary gaskets and mesh filter seals
- FDA & USP Class VI O-rings and gaskets
- LSR silicone seals and components
- FFKM perfluoroelastomer O-rings
- Electrical slip rings
- Advanced ceramics (alumina, zirconia, additive manufacturing)
Sterilisation Method Drives the Material Choice
In medical and bioprocessing sealing, the sterilisation cycle is usually the deciding factor rather than the process media. A compound has to survive the method it will actually see, repeatedly, without hardening, leaching or losing its seal.
Steam autoclaving favours EPDM and platinum-cured silicone. Gamma irradiation and ethylene oxide each affect compounds differently, and repeated cycles matter more than a single exposure. Where the cleaning chemistry is aggressive or purity requirements are highest, FFKM covers conditions the others cannot.
Tell us the sterilisation method, how often it runs, and whether the seal is in patient-contact or process-contact service. Where documented biocompatibility is required, our USP Class VI seals page sets out the compliant grades and the documentation available.
Bioprocessing Seals & Sealing Solutions
Bioprocessing equipment places demanding requirements on seals and gaskets because components can be exposed to repeated cleaning, sterilisation, high-purity process media and tightly controlled production environments.
International Seal supplies bioprocessing seals for pharmaceutical, biotechnology and life-science equipment, including O-rings, hygienic gaskets and specialist elastomer sealing components. Products can be selected according to operating temperature, process media, cleaning and sterilisation method, pressure and applicable material requirements. Applications range from hygienic process connections and fluid-handling equipment to pumps, valves, filtration systems, vessels and other biopharmaceutical processing equipment.
Typical Bioprocessing Applications
- Pharmaceutical and biopharmaceutical process equipment
- Hygienic fluid-transfer systems
- Pumps and valves
- Filtration and separation equipment
- Process vessels and associated pipework
- CIP and SIP systems
- Sampling and fluid-handling equipment
- Laboratory and life-science processing systems
Seals for Bioprocessing Equipment
Depending on the equipment and application requirements, sealing options may include:
- O-Rings — elastomer sealing for static and selected dynamic applications
- Hygienic Gaskets — including Tri-Clamp and other sanitary process connection profiles
- Screen Gaskets — hygienic gaskets incorporating mesh for process filtration applications
- Custom Moulded Components — non-standard elastomer components supplied to drawing or specification
- FFKM Seals — for particularly demanding chemical, temperature and process environments
- USP Class VI Elastomer Seals — selected compliant elastomer options for applications requiring documented biological-reactivity testing
Materials for Medical Applications
Material selection in medical sealing is governed by biocompatibility, sterilisation method and purity as much as by mechanical performance. The right compound has to survive the cleaning and sterilisation cycle it will see in service without leaching, hardening or losing its seal.
- Silicone (VMQ) for biocompatible static sealing, tubing and device components
- USP Class VI compounds
- FKM (Fluoroelastomer) for chemical resistance and higher temperature medical process duties
- EPDM for water, steam and pharmaceutical process media
- FFKM (Perfluoroelastomer) for aggressive sterilisation and the highest purity requirements
- PTFE for chemical inertness, low friction and non reactive fluid contact
Material suitability and certification should be confirmed for the individual application. Where USP Class VI compliance is required, contact International Seal to confirm the available compliant elastomer grade and supporting documentation.
Industry Standards & Compliance
Medical and pharmaceutical sealing demands verified biocompatibility and material purity. We supply compounds tested and certified to the standards medical device and pharmaceutical manufacturers specify, including:
- USP Class VI
- ISO 10993
- FDA CFR 21
- European Pharmacopoeia (Ph. Eur.)
Material certification and test reports are available on request. Confirm the specification required at enquiry stage and we will supply the matching certified compound.
For applications requiring documented biological reactivity compliance, view our USP Class VI seals page.
Related Products
USP Class VI seals and O-rings, micro and miniature O-rings, FFKM seals, platinum-cured silicone components, PTFE components and custom moulded parts.
Request a Medical or Bioprocessing Seal Quote
Send us your seal type, dimensions, drawing, material requirement, process media and operating conditions. If a specific compliance standard is required, include this with the enquiry so we can confirm suitable available materials and documentation.
Medical & Bioprocessing Sealing FAQs
What is a USP Class VI seal?
A seal made from an elastomer that has passed USP Class VI biological reactivity testing, the most demanding of the USP plastics classifications. It is used where documented biocompatibility is required for medical, pharmaceutical and bioprocessing equipment. See our USP Class VI seals page for available grades.
What is the difference between USP Class VI and ISO 10993?
Both address biocompatibility but from different directions. USP Class VI is a materials classification based on a defined set of biological reactivity tests. ISO 10993 is a broader framework for evaluating a finished medical device, selecting tests according to how and for how long the device contacts the body. A USP Class VI compound is often a starting point for an ISO 10993 evaluation rather than a substitute for one.
Which seal materials can be autoclaved?
EPDM and silicone are commonly specified for repeated steam autoclaving. Platinum-cured silicone is used where cleanliness and low extractables matter. FKM and FFKM are selected where chemical exposure is the governing condition. Suitability depends on the temperature, cycle time and number of cycles, so confirm those when specifying.
What seals are used in bioprocessing equipment?
Typically O-rings, hygienic gaskets including Tri-Clamp and other sanitary profiles, screen gaskets where inline filtration is needed, custom moulded components to drawing, and FFKM seals for the most demanding chemical and temperature duties.
Do you supply very small O-rings for medical devices?
Yes. Micro and miniature O-rings are available for instrumentation, diagnostic and device applications where cross-sections and inside diameters are below standard ranges, with tolerances selected to suit.
What documentation can you provide?
Material certification and test reports are available on request. Tell us which standard applies — USP Class VI, ISO 10993, FDA CFR 21 or European Pharmacopoeia — at enquiry stage so the correct grade and paperwork are quoted together.