Introduction of ISO11607 medical aseptic packaging machinery performance test

Medical product designers and manufacturers need to develop not only aseptic packaging, but also other consistent products. TestResource can support testing at every step of the design and verification process. Includes: design validation, process validation, and production control.
Sterilization is an important part of the medical device industry, so manufacturers are concerned about producing medical packaging that is properly sealed. It is critical to determine the sterilization method between product developments. Medical device packaging sterilization methods include: ETO (ethylene oxide sterilization) and gamma irradiation sterilization.

ETO is a common method of sterilization of medical and medical products, and is often used in situations where conventional high temperature steam sterilization cannot be tolerated, in which ETO gas penetrates the package and kills microorganisms. Gamma irradiation sterilization sterilizes DNA and other cellular structures that destroy living cells by gamma rays.

Medical product designers and manufacturers need to develop not only aseptic packaging, but also other consistent products. TestResource can support testing at every step of the design and verification process. Includes: design validation, process validation, and production control.

Design validation is a decisive and experimental step in the product development process, and design engineering must be approved for their products through a series of test applications. The FDA stipulates that products and packaging must be certified at the same time, including rigorous testing of statistically significant quantities of samples. Our engineers are experienced in the 510k process and can help design engineers through the necessary steps to finalize the design.

Process validation includes manufacturing process testing to ensure that consistently produced products meet key specifications, including medical device products, packaging, and sterilization processes. TestResource test equipment is commonly used in manufacturing process applications such as aseptic sealed packaging testing and tensile testing.

Production control testing is a final, but repeatable, step to ensure that the package is sealed, now and in the future.

The above three steps are common international standards for the design and validation of medical device packaging. These standards are to ensure that products and packaging meet all requirements and therefore have good performance in the market.

Two of the more common sterilization medical device packaging test standards are ASTM F88 and ISO 11607.



ISO11607 sterile medical equipment packaging standard

ISO 11607-1: Material requirements, packaging system requirements and sterile barrier system requirements. ISO 11607-1 outlines a test method for sterile materials for medical device packaging. The purpose of this type of sterile barrier system is to ensure that it is sterile from manufacturing to point of use. This standard does not cover all the requirements for manufacturing a sterile barrier system or the quality assurance of the entire manufacturing process of an aseptic packaging system.

ISO11607-2: Verification requirements for forming, sealing and assembly processes. ISO 11607-2 extends the requirements for medical device packaging process validation, including the pre-fabrication of sterile shielding systems, the forming, sealing and assembly of sterile shielding systems and packaging systems. Editor: (Hardware Business Network Information Center) http://news.chinawj.com.cn

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