Seals for Medical and Pharmaceutical
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
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
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
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
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
Criteria for Hygienic Applications of
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
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
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
Rubber Industrial Co., Ltd.
No. 15, Kung Yeh East 4th Rd., Lukang, Chang Hua 505, Taiwan, R.O.C.
Mao Rubber Industrial Co., Ltd. All rights reserved.