HYGIMED SPA, a leading manufacturer of medical and hygienic devices known for pioneering the development of non-woven fabric for medical use, recently partnered with SGS Pakistan for an essential training initiative centered on the vital aspects of ETO Sterilization ISO 11135:2014 and Clean Room Manufacturing ISO 14644-1:2015 for Medical Devices.
The training took place at Hygimed SPA's facility at Algeria for two days of interactive sessions focusing on enhancing the quality and safety standards in the manufacturing processes of medical devices.
The course, titled “Understanding the Requirements of ETO Sterilization ISO 11135:2014 and Clean Room Manufacturing ISO 14644-1:2015 for Medical Devices,” was delivered by SGS Pakistan Approved Trainer Selman Iqbal.
The training was designed to provide comprehensive insights into the latest standards and best practices in the field. It addressed key topics like the requirements of Directive 93/42/EEC & MDR 2017/745 for Sterilization, aligning closely with the needs of professionals in the medical device industry.
Participants gained in-depth knowledge about the requirements of sterilization from ISO 13485:2016 and the specificities of Clean Room ISO 14644-1:2015, focusing on the sterilization of surgical instruments. The session also delved into the intricacies of sterile labeling requirements as per EN 980 and the nuances of ISO 11135:2014 concerning the sterilization of health care products by Ethylene Oxide (ETO).
ETO Sterilization and Clean Room Manufacturing training goes beyond compliance, playing a key role in enhancing quality, safety, and driving sector innovation.
The Critical Role of ETO Sterilization and Clean Room Standards in Medical Device Manufacturing
In the realm of medical device manufacturing, the adherence to stringent sterilization and clean room standards is not just a regulatory requirement but a fundamental aspect of ensuring patient safety and product efficacy. Two key standards in this domain are ETO Sterilization ISO 11135:2014 and Clean Room Manufacturing ISO 14644-1:2015.
ETO Sterilization ISO 11135:2014
Ethylene Oxide (ETO) sterilization is a critical process for medical devices that cannot withstand high-temperature steam sterilization. ISO 11135:2014 provides detailed guidance on the requirements for the development, validation, and routine control of a sterilization process for medical devices. This standard is vital in ensuring that medical devices are free from harmful microorganisms, thereby ensuring patient safety.
Clean Room Manufacturing ISO 14644-1:2015
The environment in which medical devices are manufactured plays a pivotal role in their safety and effectiveness. ISO 14644-1:2015 specifies the classification of air cleanliness in terms of the concentration of airborne particles in cleanrooms and clean zones. Strict adherence to this standard is essential for preventing contamination during the manufacturing process, particularly for devices intended for implantation or those that come in direct contact with internal tissues.
SGS: Elevating Standards in Medical Device Manufacturing in the Middle East
The significance of ETO Sterilization ISO 11135:2014 and Clean Room Manufacturing ISO 14644-1:2015 cannot be overstated in the context of medical device safety and efficacy. By empowering professionals with the latest knowledge and skills, SGS is contributing to the elevation of industry standards and ensuring the delivery of safer, more reliable medical devices.
About SGS
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.
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