Looking For Contract Ethylene Oxide Sterilisation
Facility?

Bansi Dhurandhar
Director
MICROTROL Sterilisation Services Pvt. Ltd. |
Terminal sterilisation is the most
important step in manufacturing of sterile medical
devices. Extensive use of plastics and polymers as
material for construction has necessitated conducting
sterilisation at lower temperature. The most common
methods are fumigation with Ethylene oxide gas and
Ionization radiation using Gamma irradiation or
Electron beam.
Ethylene oxide sterilisation is by
far the most popular and convenient method of
sterilisation for most medical devices. It is believed
that more than 60%of medical devices the world over
are sterilised by Ethylene oxide gas. Though the
process seems to be simple, compliance to various
quality standards, reliable automation, safety
requirements and environmental issues etc. have made
this popular technique face frequent upgradation. For
manufacturers of medical devices therefore, it becomes
an extremely important decision either to have
in-house sterilisation facility or rely on contract
service providers. |
In earlier days, making
a choice between contract service provider and in-house
facilities was based purely on economic considerations. If
the volume of devices produced per day requiring
sterilisation justified investment and running cost; an
inhouse facility was the answer. The small manufacturer
could not establish in-house sterilisation facilities as
Capex was relatively high. Therefore, they would patronise
a contract facility. Large manufacturers too relied on
contract facilities as their production volume
necessitated sufficiently large Sterilisation capacities
which was akin to running a separate activity with
dedicated personnel and also resulting in diverting
attention away from their core business.
However, a large number
of medium scale manufacturers face a dilemma in taking a
decision. Cost of primitive looking Sterilisation chamber
made of Carbon steel and vacuum pump with basic
instrumentation without automation can be installed at
reasonable cost and running the same without regulatory
measures appears to be an extremely attractive
proposition. Further, it reduces transportation costs,
making the decision to have in-house facility appear
attractive. However, quality consciousness, compliance to
various standards, meeting statutory requirements like
Food & Drug Administration, Medical Devices Rules, Factory
inspectorate, Pollution control, Labour laws and insurance
are some aspects which need due attention. It is true that
in addressing all these results in a drain on resources.
Hence, many
manufacturers select a good contract sterilisation service
which turns out to be economical and convenient in the
long run. The choice of the appropriate contract facility
thus becomes the next important step.
Equipment :
A Contract facility
should have the latest equipment. The “EtO Steriliser” has
undergone severe technological advances over the years.
While the equipment should qualify and meet quality
requirement, it should also ensure intrinsic safety by
virtue of selection of material of construction,
appropriate accessories and state of the art
instrumentation.
Gone are the days, when
an EtO Steriliser was just a metal box connected to a
vacuum pump and cylinder containing an Ethylene oxide gas
mixture. The equipment today needs to comply with DIN EN
1422 requirements and provision for additional ports to
introduce sensors for validation. Controls should be fully
automatic through PLC and must have a facility to
continuously monitor pressure, temperature, humidity and
time. All instrumentation must be of flame proof rating.
It should meet the installation qualification criteria in
terms of leak rates, temperature profile and loading
configuration essential for theproduct to be sterilised.
Process :
Having identified a
conveniently located contract facility and their
capability in terms of adequate and appropriate equipment,
the process of sterilisation becomes the next important
aspect. Most contract facilities have pre-established
standard procedures. It is important to ensure that these
standard procedures do not physically affect the product
or damage integrity of its packaging. Some polymers are
known to develop deformities due to overexposure at later
date.
It of utmost importance
to ensure that all gauges, instruments, sensors etc. are
periodically calibrated by a qualified agency and their
schedules are strictly observed.
Validation :
Equipment qualification
and process validation are just not buzz words but should
be the password for a medical device manufacturer and the
sterilisation services provider..
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