Among the blister boxes, medical aseptic packaging and food-grade are both under the jurisdiction of the food and drug supervision and administration institutions. This paper will assess the irreplaceability of the two from the perspective of risk management.
1. About access approval certification
Internationally, food packaging needs to pass ISO22000, while medical device packaging needs to pass ISO13485, although it belongs to third-party certification, the difference is mainly in the verification and sterilization requirements of materials. And medical packaging verification and batch consistency requirements will be higher. In China, the medical industry is also following up and converging with the international market. Originally, packaging materials manufacturers were not required to provide ISO13485 certification. Now it is also a proposal. Although there is no registration system for the certification of packaging materials manufacturers, the risks are placed on the equipment manufacturers. The packaging materials for the food industry require QS certification for packaging materials manufacturers, which is a government-led certification system.
2. Risk from raw materials
The choice of materials is a prerequisite for quality. Medical grade blister boxes require medical grades for raw materials. The control and requirements from the initial raw material particles to the forming sheet are much higher than those of food grade blister boxes. The most basic requirements for the selection of medical blister boxes are environmentally friendly sheets, which meet ISO10993 and ISO11607 certifications and can meet microbial barrier protection, excellent sterilization methods, biocompatibility and prevention of related infections (HAI). For example, Class III medical device blister boxes are basically designated by the manufacturer for the selection of material grades, manufacturers and quality standards. If you specify Eastman PETG6763, you cannot use recycled materials, recycled materials, etc.
Although the US FFDCA Code of Federal Regulations (CFR) sets clear requirements for food packaging materials, the development of the food packaging industry is also morbid due to well-known reasons in the field of food safety in China. At present, there are nearly 10,000 enterprises producing food packaging materials in the country, and there are many varieties of products. The production scale of enterprises varies greatly, and there are many small-scale workshop-style production enterprises. Food packaging on the market is full of industrial materials and materials. In particular, the return material, after UV sterilization, a large amount of harmful substances are precipitated, posing a threat to human health. In particular, food safety problems caused by food packaging materials have emerged in recent years, such as the incident of phthalate plasticizers in plastic packaging materials and films, and RPET has replaced APET.
The most obvious example is that the main raw material for the production of lunch boxes is polypropylene, but manufacturers often add industrial calcium carbonate as a filler during the production process. Because industrial calcium carbonate is a kind of powder, the plasticity is relatively poor. When the excess amount is used, the powder is difficult to bond together, so the produced lunch box is prone to quality problems such as softness and leakage. Therefore, manufacturers must also add a special raw material - industrial paraffin. Industrial paraffin contains carcinogens, polycyclic aromatic hydrocarbons, and is easily consumed by consumers. Food-grade blister boxes are used in foods that are not used, not to mention the use of more demanding medical grade blister boxes.
3. Risk of mold and equipment process
The medical plastic box on the mold is made of aluminum mold, and the materials are mainly ZL401, 6061 and 7075. However, 6061 is a better material in terms of overall mold processing accuracy and various properties, so the mold of the medical grade blister box uses 6061 aluminum. The molds of the food blister boxes are not well-made, and there are aluminum molds and copper molds. Even when the production batch is small, plastic molds are used. The copper mold is actually the structure of the copper outside the powder, and the cleanliness cannot meet the requirements of the medical device packaging.
Large food-grade blister box manufacturers generally use one-piece molding machines, which adopt low-temperature high-speed upper and lower mold clamping methods. The output is large and the efficiency is high. However, the medical industry products are generally more varieties and fewer. Integral molding machines, although the product feels that the housing is hard, the physical properties of the product (such as drop resistance) are relatively poor and prone to stress deformation. There is a greater risk: because the one-piece molding machine is extremely efficient, and the punching section has the edge chippings flying out despite the measures of heating the die, once it enters the casing, it is difficult to check with the lamp inspection table. . If the automatic stacking of the blister box is taken apart, it is easy to cause secondary scratches and affect the appearance quality (scratch is also one of the causes of insoluble particles).
4. Risk in the production environment
Medical grade blister boxes require a cleanroom of 1-10 million or higher. However, the production environment of food-grade blister boxes is uneven, and some even 300,000-level clean workshops cannot be guaranteed, but they all have QS certification. And medical grade blister boxes require stricter control over insoluble particulates and initial contaminating bacteria during the production process. Especially the packaging of Class III medical devices.
However, the production environment of food-grade blister boxes is far from meeting these requirements, because these quality control requires a professional laboratory, that is, a live bacteria operation room and a microbial limit room. It also requires professionally trained professional laboratory personnel and professional equipment to test. These are just food-level blister boxes that are currently unattainable.
5. Risks in related experiments and packaging verification
Medical device packaging verification is different from packaging verification for food or other industrial products. The packaging verification of medical devices has designated authoritative safety assessment laboratories and institutions to evaluate the safety and effectiveness of medical device packaging blister boxes scientifically and efficiently.
From the biocompatibility and toxicological properties of raw materials, physical and chemical properties, to the suitability of the blister forming and sealing process, to the expected sterilization process, expected design expiration, mode of transport, etc., throughout The microbial barriers of packaging systems, etc., have strict verification procedures and laws and regulations. And these professional packaging verification is currently lacking in the food packaging industry.
At present, there is still a certain gap between the food packaging material standards and the food packaging standards of developed countries in Europe and the United States, which are manifested in the problems of lack of standards, crossover, health quality standards and industry standards. Not to mention the replacement of medical grade blister boxes with food grade blister boxes.
In summary, if a food-grade blister box is used instead of a medical-grade blister box, the medical device packaged in a food-grade blister box may become a deadly weapon, not to rescue the patient, but to become a "killer". Sharp weapon.
The packaging of medical devices is a life barrier, which is crucial from the selection of packaging materials, structural design, process execution and packaging laboratory testing. And not only to consider the chemical and physical properties of packaging materials, but also to consider the process validation of sterilization packaging. That is, the performance after initial, sterilization, and accelerated aging is considered. The choice of packaging that meets the requirements of sterility is the only choice for medical device manufacturers. The concept of adapting to sterilization technology is the highest guarantee for medical device products.