An article to the magazine "Clean rooms" ¹55
A new article has been written about the sterilization by ethylene oxide.
The use of ethylene oxide is a very popular method of disinfection from manufacturers of medical products. However the manufacturers need to be aware of the publications of new standards and regulatory changes to their operations to comply all the innovations in their occupation.
The last version of the standard ISO 11135:2014 was published in July 2014 and it combines all new requirements and replaces by the standard ISO 11135-1:2007 and ISO/TS 11135-2:2008.
In this regard, the manufacturers were encouraged to review their existing procedures to ensure that the wording used in the new version of the standard 2014 match the existing. Manufacturers also need to revise existing procedures from the point of view of terms and definitions to ensure a clean consistency with the new standard. And in addition the functional requirements must be included in the existing quality system on the enterprise.
In addition to the main, it is useful to have a backup business plan to increase production in the event of tightening of the regulatory requirements.