Protection of the product: microbial barrier; protection of the product from external damage;
Maintain sterility and integrity until the product is used;
Easy to open and aseptic transfer;
Labeling of the product, clear identification of product information and warnings.
Requirements for medical blister packaging and handling:
Clean peel, aseptic access
Adequate sealing strength of the blister packaging of the product to form a microbial barrier;
Ability to achieve clean peel and aseptic access, the peel layer should be continuous and uniform, the material should not be divided into layers or torn, to prevent contamination of the particles;
Opened in the correct way: Two-handed operation, correct access, safe delivery;
Clearly labeled product information and warnings, checking the operation and expiration date.
This is the formation of the primary packaging of the various aspects of the requirements:
On the material itself and its production company requirements;
On the medical blister box packaging companies put forward the relevant requirements;
On the sealing process of medical blister packages and its design and production process, and even the outer packaging of the relevant requirements (systems);
On the sterilization process put forward requirements for the sterilization process;
requirements for printing and inks;
requirements for the transportation process.
Hospitals are becoming more and more stringent in their requirements for the initial packaging of medical devices, which is not only a standardization of the overall system of medical devices, but also a test for blister manufacturers.
? There are many kinds of medical packaging materials, the initial packaging belongs to the important part of the sterile medical devices has become the industry **** knowledge, must be certified by the ISO13485, YY/T0287 quality system and to ensure that the continuous control, according to the standard process at a time to do the right.