Packaging materials and systems for medical devices which are to be sterilized

2015 ◽  
2020 ◽  
pp. 27-40
Author(s):  
Galina Nikolaevna Melnikova ◽  

The article discusses issues related to the creation and use of packaging materials for different types of products, including those specially designed for placing medical devices in them, before sterilization. The changes taking place related to the improvement of the barrier properties of packages to extend the preservation period of sterility of medical devices (both new types and complex in design) sterilized by different methods are noted. It is shown how over the course of several years new materials have been developed, technologies/methods of processing and reprocessing of raw materials and materials have changed, which make it possible to obtain packaging materials of different chemical nature and properties. Changes in existing packages from traditional materials (metal) to of single-use sterilization packages of a new generation with improved manufacturing technologies that provide mechanical, barrier and antimicrobial properties of packages differing in types, sizes, material properties are noted. The priority in the use of packaging materials for medical devices remains for materials that meet the requirements of GOST ISO 11607 "Packaging for medical devices subject to terminal sterilization", since the standard imposes more stringent requirements for the execution of packaging materials.


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