Ethylene Oxide EO Sterilization & Validation

Muzacorp provides advanced Ethylene Oxide (EO) sterilization processing according to to ISO11135 standards. Our ISO scope enables us to manage both validation and on-going sterilsation processes so that we are able to provide our clients with complete documentation and traceability. Using an advanced tracking, barcode and recording systems, we are also able to monitor the movement and also the status of your goods.

As a contract sterilization services supplier, using all the major sterilization processes, we can provide ETO sterilization process, to the highest standards, cost effectively, for your products.To date, we have also been assisting our clients with regulatory matters such as facility registration, sterilization validation and certification of products for export.

The relatively low process temperature (in comparison to steam sterilization) has made Ethylene Oxide sterilization an excellent, proven and effective method for the sterilization of medical devices.

• Sterilization of healthcare products —Requirements for validation and routine control
• Medical devices — Validation and routine control of ethylene oxide sterilization, AAMI/ISO 11135
• Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization, EN550 (European standard)
• Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residues, AAMI/ISO 10993-7
• Sterilization of medical devices — Microbiological methods, Part 1: Estimation of population of microorganisms on products, AAMI/ISO 11737-1
• Sterilization of medical devices — Microbiological methods, Part 2: Tests of sterility performed in the validation of a sterilization process, AAMI/ISO 11737-2
• Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization
• ETO Residuals, ANSI/AAMI/ISO 10993-7

Being within the Klang Valley area, we are close to the point of production and distribution, hence providing flexibility and also reduced logistics costs. We offer pick-up services of non-sterilized goods and also delivery services for sterilized products at a very competitive rate.