Working closely with industry leaders in the medical and pharmaceutical
processing industry, Gmors provides solutions to the most demanding sealing
applications particularly in CIP (cleaning-in-place) and SIP
(sterilization-in-place) processes where automatic cleaning and disinfecting
is carried out with minimal dismantling.
Specifying the right elastomeric sealing material for use in pharmaceutical equipment is not an easy task because in addition to FDA standard 21 CFR 177.2600 compliance, CIP processes employ the use of harsh chemicals which have a deleterious effect on elastomeric sealing materials. SIP processes further subject seals to superheated steam of up to 140 degrees C. Products to be processed may also contain particles and solids which have an abrasive effect on sealing materials.
Elastomeric Seals Compatibility for CIP and SIP Applications
We have determined from our many years of experience working with pharmaceutical equipment manufacturers that elastomeric material compatibility varies significantly depending on the specific CIP media used and the SIP environment.
Sealing materials that comply with FDA and USP Class 6 are found in many pharmaceutical equipment. In processes that involve water-based materials, EPDM (ethylene propylene diene M-class rubber) which is highly water resistant is the material of choice for most equipment. Where chemical media is employed in processes, HNBR (hydrogenated nitrile butadiene rubber) exhibits enhanced performance. However, neither EPDM nor HNBR can effectively satisfy the combined requirements of chemical and thermal resistance and low swell characteristics at the same time. HNBR is susceptible to swelling in steam while EPDM lacks resistance to chemicals.
Standard FKM (fluoroelastomer) has the advantage of better resistance at elevated temperatures, and it has also displayed compatibility with most cleaning chemicals and solvents. However, its ability to withstand steam and hot water is less than satisfactory, resulting in an increase in the frequency of seal replacement in production processes.
The recommended elastomeric materials for use in sealing applications for aseptic connections, as required by DIN 11864 and DIN 11851, include EPDM, HNBR, VMQ, and FKM. However, it is important to note that some of these compounds do not perform to expectations under the harsh environments of CIP and SIP. Perfluoroelastomers (FFKM), though not included in the DIN recommendations, have the highest level of compatibility, meeting the performance requirements of CIP and SIP process where seals are subjected to harsh chemical media at elevated temperatures. However, the high cost of perfluoroelastomers is a cause for concern for both specifiers and equipment manufacturers.
Gmors Platinum Cured Silicone Seals: The Ultimate Hygienic Seal
Silicone elastomers have both physical and chemical properties that make it desirable for use in medical and pharmaceutical applications. However, the method of curing for silicone can result in different characteristics in the final product.
Platinum cured silicones have enhanced resistance to aggressive chemicals and resins in addition to almost zero shrinkage in production. The resulting product exhibits improved tear strength and greater dimensional stability. Other benefits include improved thermal resistance, resistance to aging, non-stick characteristics as well as non-toxicity.
Gmors offers platinum cured silicone seals for hygienic applications with the distinct advantage of minimal contamination and extractables. Production processes meet the standards of U.S. Pharmacopeia Class VI Certification, CFR Title 21 Section 177.2600 and 3-A Sanitary Standards, with complete lot and batch traceability and certification.
Criteria for elastomeric seals in hygienic applications
1. Chemically resistant against product to be sealed
2. Non-toxicity of sealing material
3. Abrasion resistance, wear resistance
4. Ability to withstand high temperature cleaning processes and sterilization
5. Resistance to CIP media used in cleaning processes
6. Resistance to superheated steam and pressure in SIP processes
7. Low gas permeability
8. Stability and compatibility with mineral oils, fats and greases
Matching your requirements
Gmors offers customized molded parts for specialized applications in addition to our core business in o-rings and seals. Our customers benefit from our many years of manufacturing experience, tool design capabilities and cost efficient production methods. Matching the sealing application with the most suitable sealing compound often requires a customized approach, and we offer free consultation at every stage of your project to help you arrive at your final solution.
Contact us about your requirements and let us work on a proposal for you.
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