Our new Technical Services Division has extensive experience in the sterilisation and scientific support industry, which means we can offer a unique insight into the services required to meet the regulatory needs of the medical device industry.The services offered include the below:
Bioburden Analysis
Ethylene Oxide Analysis
Environmental Monitoring
| Consultancy and Training
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Project Management
Our Technical Services team are always
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Ethylene Oxide SterilisationThe treatment of medical devices by ethylene oxide (EtO) has been the principle method of sterilisation and has become industry standard. Ethylene oxide processing involves products being exposed to the gas under vacuum in a sealed chamber. This is achieved in three phases: Phase 1 PreconditioningProducts are placed in a preconditioning cell that is designed to raise the core temperature, typically to 40-50 degree centigrade and controlled humidity. This is the first step to optimise the sterilisation process efficiency. Phase 2 ProcessingProducts are moved by automatic transfer into the main chamber where the ethylene oxide gas is introduced under vacuum for a predetermined dwell time. This validated process is designed to deliver the required sterility assurance level in accordance with ISO11135. Phase 3 Heated AerationIn the final stage, the product is moved by automatic transfer into a preheated cell which uses circulated air to remove residual ethylene oxide within the products. | Our promise to youAs a leading provider of medical products including custom procedure packs, Unisurge International has the experience and capability of meeting your requirements for sterilisation processing.
“All at the most cost effective prices”
The Unisurge VisionTo offer each and every customer the same high standard of service whether incubating a simple environmental settle plate through to a complex Ethylene Oxide process validation. |