ETHYLENE OXIDE

Contract sterilization

Ethylene oxide (EO) processing sterilizes products making an alkylation reaction that eliminates the capability of the microorganism to reproduce. The process consists of four components:

• Handling
• Conditioning
• Sterilization
• Aeration

Steri-Tech, Inc. specializes in the sterilization of both Pharmaceutical Products and Medical Devices. It is a fine tuned process which begins the moment the product arrives at our facility. All products are thoroughly inspected and duly recorded as they enter our facility, and are then placed in a quarantined warehouse to avoid any contact with products already processed.From there they are taken to a pre-conditioning room, where they are prepared for and undergo the sterilization process. The EO sterilization requires the control of four parameters: gas concentration, temperature, relative humidity and time of exposure in one of our four chambers/units that use 100% EO.

Once processed, the product is placed in an aeration cell where residual gas, called ethylene chlorohydrins, that results from the reaction of EO to moisture and chloride ions, is eliminated to ensure the safe handling of the product and reduce costly product inventory to our customers.

EO = method of choice to:

• Sterilization of custom procedure kits containing unit dose drugs in hermetically sealed packages and/or other irradiation sensitive materials.
• Cellulosic and plastic products that exhibit discoloration with irradiation.
• Plastics whose physical properties degrade with irradiation.
• Certain products that contain components which must be reclassified as drugs when processed with irradiation.
• Nearly all material is compatible.
• Highly compatible with polymer-based single-use medical devices, procedure kits and surgical trays.

Our services include:

• Product Pickup and Delivery
• High Quality Service
• Cycle Development – Identifies the hardest area to sterilize within your product. It also identifies this area’s relationship to the bioburden that is induced during the manufacturing process.
• Product and Process Validation – For customers that lack in-house validation expertise or prefer to use outside validation services.
• Parametric Product Release – Sterility is confirmed, not by reading the biological indicator (BI) but by establishing processing specifications for gas concentration, temperature, relative humidity and time of exposure, then monitoring activity in the chamber load to verify that each condition has been met. Then the product is ready for release with assured sterility based on actual verifiable data rather than empirical data and freedom from the costly delays associated with the use of BIs.
• Laboratory Testing
• Temperature Profiles
• Product Pre-Conditioning – Provided by high velocity air circulating system with no condensation within sterilization chambers.
• Advanced Computer Control Systems
• High Efficiency oil sealed evacuation system
• 100% EO, with EO/Nitrogen Capability for vacuum sensitive packaging
• Product Aeration – With temperature control up to 135 grades Fahrenheit.
• Complete Documentation