Medical Plastic Data Service Magazine



Our 27th Year of Publication
Page  9 of 11

Cover Story

Looking For Contract Ethylene Oxide Sterilisation Facility?

Bansi Dhurandhar
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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