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O-Rings and Seals for Medical and Pharmaceutical Applications

GMORS delivers o-rings and seals to major manufacturers of equipment in the pharmaceutical and medical industries, and work closely with our customers to resolve some of their most demanding sealing requirements especially in the sterilization-in place (SIP) and cleaning-in-place (CIP) procedures whereby automatic disinfection and cleaning proceeds with little or no dismantling of equipment.

The correct choice of elastomeric seals and its material for use in equipment in the pharmaceutical industries is based upon compliance with FDA standard 21 CFR 177.2600. The deleterious effects of corrosive chemicals used in CIP processes can be damaging to elastomeric sealing materials. Steam that is superheated to 140 degrees C during sterilization procedures subject sealing components to further abuse. Abrasion and wear is another factor to consider because processed products may consist of solids and particles that may come into contact with elastomeric seals.

O-Rings and Seals: Compatibility with Clean-in-Place and Sterilization-in-Place Procedures

Chemical media used in CIP procedures as well as the SIP environment relates to the compatibility of elastomeric material used in such equipment. GMORS has supplied o-rings and seals to leading pharmaceutical equipment manufacturers for many years, and is well equipped to meet all your sealing needs.

Many pharmaceutical equipment manufacturers choose GMORS as their preferred supplier of elastomeric seals because of our many years of experience and our compliance with USP Class 6 and FDA standard. In processes involving the use of water-based materials, the material of choice for sealing components is ethylene propylene diene M-class rubber (EPDM) due to its excellent water resistance properties. HNBR (hydrogenated nitrile butadiene rubber) works well in environments where o-rings and seals are exposed to corrosive chemical media in processes. However, when HNBR is exposed to steam, it is susceptible to swelling while EPDM may not withstand attack from corrosive chemicals. In operating environments where increased thermal and chemical exposure is expected and low swell properties is a requirement, neither HNBR nor EPDM is a suitable choice.

Fluoroelastomers (FKM) exhibits improved thermal resistance and works well under exposure to most solvents and cleaning chemicals. However, steam and hot water can have a damaging effect on it, giving rise to a higher frequency of replacement of sealing components.

DIN 11864 and DIN 11851 standards provide guidelines for the choice of elastomeric materials for sealing applications involving aseptic connections. And that includes HNBR, FKM, EPDM and VMQ. However, it should be noted that under conditions of CIP and SIP processes, some of these compounds may fall short of expectations. Perfluroelastomer (FFKM) exceeds all other materials in terms of compatibility although not listed in the DIN guidelines, performing to requirements under the harsh operating conditions of CIP and SIP processes where seals are exposed to highly aggressive chemicals at high temperatures. The only setback for using perfluoroelastomer seemingly is its high cost, a matter to consider for both equipment designers and manufacturers.

GMORS Ultimate Hygienic Seal: Platinum Cured Silicone Seals

The chemical and physical characteristics of silicone elastomers made it ideally suited for use in pharmaceutical and medical applications. However, silicone can be cured in specific ways resulting in properties that are different in the end product.

Platinum cured silicones exhibit near zero shrinkage with increased resistance to resins and corrosive chemical media. Dimensional stability is enhanced and tear strength increased in the final product. Additional advantages of platinum cured silicones are aging resistance, improved heat resistance, non-toxicity and non-stick characteristics.

Platinum cured silicone seals is offered by GMORS as a solution to the sealing requirements of hygienic applications, minimizing the risks of contamination and extractable. Manufacturing processes comply with the requirements of 3A-Sanitary Standards, CFR Title 21 Section 177.2600 and US Pharmacopeia Class VI certification, along with certification and lot and batch traceability.

Criteria for Hygienic Applications of Elastomeric Seals

1. Resistant to chemicals found in product to be sealed.
2. Sealing material must be non-toxic.
3. Resistant to abrasion and wear.
4. Ability to function under conditions of elevated temperature during CIP and SIP processes.
5. Compatible with chemical media used under high temperature cleaning processes.
6. Resistant to high pressure superheated steam during sterilization processes.
7. Low permeability to gas.
8. Compatibility and the ability to remain stable when exposed to fats, greases and mineral oils.

GMORS Matching Your Requirements

GMORS offers o-rings and seals and customized molded parts for use in special sealing applications. Our cost efficient manufacturing process, tool design capabilities and years of experience ensure that our customers expectations are met. We offer free consultation at every phase of your project, matching your sealing application with the most compatible elastomeric material in a customized approach.