Analysis of medical device packaging materials standard blister packaging

【Chinese Packaging Network News】 Blister packaging is widely used in disposable medical devices, especially low-value consumables. Such as syringes, indwelling needles, various types of catheters. The overall structure of the blister pack consists of a blister film and synthetic paper (or Tyvek).

The process of blister packaging can be simply described as follows: film formation, product placement, sealing, marking, and cutting. Of course, different platforms can be built according to different products, and semi-automatic or fully-automatic packaging of products can be achieved. In general, simple products make it easier to fully automate packaging. Such as a syringe.

In general, the quality of blister packaging affects the vacuum die, drawing speed, seal heating temperature and time, marking position and clarity, cutting incision and location.

The inspection items that the plastic film should do when entering the instrument factory can refer to this standard. At the same time, this is also a quality assurance book item that packaging companies should do. Mainly includes appearance detection, physical properties. There are also some logo requirements.

Did everyone realize that there was no mention of chemical or biological requirements here? In fact, this document is based on ISO11607. Only when the material meets the basic requirements of ISO11607 is it necessary to carry out the next test. ISO 11607 is also translated into the national standard GB/T19633.1-2015 "Finally Sterilized Medical Device Packaging Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems," which was September 1, 2016. The requirement after forming and sealing is GB/T19633.2-2015 "Finally Sterilized Medical Device Packaging Part 2: Forming, Sealing and Assembly Process Confirmation Requirements".