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Looking For Contract Ethylene Oxide Sterilisation
Facility?
Validation is in three
parts:
• Installation
qualification
• Operational qualification and
• Performance qualification.
The specification to
which the steriliser is manufactured and respective
compliance becomes part of installation qualification.
Operational
qualification is related to the performance of the
equipment; this is normally done without the product
Performance qualification is in two parts; this involves
the actual product to be sterilised.
• Performance
qualification physical: where critical parameters like
temperature profile, rate of evacuation and increase in
pressure proportionate to quantity of gas, etc. are
defined with repetitive trials.
• Performance qualification microbial: is achieved by
half-cycle qualification with sterility assurance level of
10-6, by using biological indicators. The service provider
must provide a validation protocol and carry out periodic
process validation which is product specific.
Compliance to
regulatory standards:
Medical device
manufacturing is a highly regulated process. ISO
13485-2016 is the standard for Quality management systems
for medical devices while ISO 11135-2014 specifies
requirements for sterilisation of health care products
with Ethylene oxide.
It should be mandatory
for a quality medical device manufacturer to ensure that
the contract sterilsation services provider has been
audited and certified by a notified body to comply with
the requirements of ISO-13485 and ISO-11135.
There is one more facet
that needs attention while selecting a qualified contract
Sterilisation service provider. Ethylene oxide is very
toxic and hence it is the responsibility, both, moral and
societal of the service provider to ensure appropriate
disposal of used Ethylene oxide gas. Catalytic converters,
flare towers and abatement systems are some of the
equipment which are used effectively. However, in reality
to save money, many facilities do not install such
equipment and release Ethylene oxide into the atmosphere
instead.
New regulations are
being proposed to monitor and control EO levels in
environment but it is the moral responsibility of the
device manufacturer to ensure that their sterilisation
contractors provide for EtO abatement systems that
manifests that they are not only law abiding but socially
conscious citizens.
A contract sterilsation
service provider, meeting all the above requirements is
the answer for a quality Medical device manufacturer;
after all, they deal with lifesaving devices and therefore
need to ensure that the product being manufactured meets
International standards and contributes to our Hon. Prime
Minister, Narendra Modi’s ‘Make in India’ objective.
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Bansi Dhurandhar is the
pioneer of Ethylene oxide sterilisation in India. Working
in the field of sterilisation for last 45 years, he has
witnessed the medical device industry grow from it’s
infant stage. He has been duly recognised by Intellectual
property Organisation, Geneva for his work in the field of
sterilisation for developing countries. He is Director of
Microtrol Sterilsation Services Pvt. Ltd. which
specialises in offering sterilisation services through
it’s facilities spread all over the country. This includes
EtO sterilsation, Gamma irradiation, Electron beam and
Natural pasteurisation by steam.
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