Medical grade blister box, why can't you use food grade blister box
In blister box products, medical aseptic packaging and food grade belong to the jurisdiction of the food and drug supervision and administration agency. This paper will evaluate the irreplaceability of the two from the perspective of risk management.
Raw material risk
The choice of materials is a prerequisite for quality assurance. Medical grade blister box on the raw material requirements are medical grade. The control and requirements from the initial raw material particles to the molded pieces are much higher than those of food-grade blister boxes.
The most basic requirement for selecting a medical blister box is an environmentally friendly sheet that meets ISO10993 and ISO11607 certification, which can meet microbial barrier protection, excellent sterilization methods, biocompatibility, and prevention of related infections (HAI). For example, the blister box of Class III medical devices basically stipulates the material grade, manufacturer and quality standard selected by the manufacturer. If you specify Eastman PETG6763, you cannot use recycled materials, recycled materials, etc.
Food packaging on the market is flooded with industrial and recycled materials. In particular, recycled materials, after ultraviolet sterilization will precipitate a large number of harmful substances, posing a threat to human health. In recent years, food safety issues caused by food packaging materials have emerged one after another, such as the use of o-benzene plasticizers in plastic packaging materials and films, and the use of RPET instead of APET.
The manufacturer must also add a special raw material-industrial paraffin wax. Industrial paraffin wax contains carcinogenic polycyclic aromatic hydrocarbons and is easily consumed by consumers. The raw materials of food-grade blister boxes are not approved for food, let alone the production of medical-grade blister boxes with higher requirements?
03
Risks in tooling and equipment processes
The medical blister box on the mold adopts aluminum mold, and the materials are mainly ZL401, 6061 and 7075. But from the overall mold processing accuracy and various properties, 6061 is a better material, so the mold uses 6061 aluminum medical grade blister box. The mold production of food blister box is uneven, such as aluminum mold, copper mold, and even the use of plastic mold in the production of small batch. The copper mold is actually the structure of the inner powder and the outer copper, and the cleanliness cannot meet the requirements of medical device packaging.
04
Risks in the production environment
Medical grade blister boxes need 10000-100000 or higher clean workshop. However, the production environment of food-grade blister boxes is uneven, and some even 300000-grade clean workshops cannot be guaranteed, but they all have QS certification. In addition, medical-grade blister boxes require stricter control of insoluble particles and initial contaminating bacteria during the production process. In particular, packaging for Class III medical devices.
However, the production environment of food-grade blister boxes is far from meeting these requirements, because these quality controls require professional laboratories, live bacteria operating rooms and microbial limit rooms. Formally trained professional laboratory personnel and professional testing equipment are also required. These are the current food grade blister box can not match.
Xiamen Dacheng
2020-11-20
Xiamen Dacheng supplies ASA blister board and ODM & OEM processing service
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No. 19, Baihuyan Road, Houxi Town, Jimei District, Xiamen, China 503
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E-mail：8001@xmdcsj.cn