Metric O-Ring Size and Standard Sizes
Medical and Pharmaceutical O-Rings and Seals
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
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°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
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
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.
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.
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
Platinum Cured Silicone Seals: The Ultimate Hygienic
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.
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.
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.
for elastomeric seals in hygienic applications
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
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
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.
about your requirements and let us work on a proposal for you.
Rubber Industrial Co., Ltd.
No. 15, Kung Yeh East 4th Rd., Lukang, Chang Hua 505, Taiwan,