Difference between sterile plastic box and food gr
1. About access approval and certification
Internationally speaking, food packaging needs to pass ISO22000, while medical device packaging needs to pass ISO13485. Although both belong to the third-party certification, the difference mainly lies in the material verification and sterilization requirements. Moreover, the requirements for validation and batch consistency of medical packaging will be higher. In China, the medical industry is also further following up and converging with the international market. In the past, packaging manufacturers were not required to provide ISO13485 certification, but now it is also a suggestion. Although there is no registration system for the identification of packaging material manufacturers, the risk is put on the equipment manufacturers. Packaging materials in the food industry need QS certification from packaging manufacturers, which is a government led certification system.
2. Risks from raw materials
The selection of materials is the premise of quality assurance. Medical grade blister box requires medical grade raw materials. From the initial raw material particles to the sheet for molding, the control and requirements are far higher than the food grade blister box. The most basic requirements for material selection of medical blister box are to select environmental protection sheet materials, which meet the requirements of ISO10993 and iso11607 certification and can meet the requirements of microbial barrier protection, excellent sterilization method, biocompatibility and prevention of related infection (HAI). For example, the class III medical device blister box basically specifies the manufacturer to select the material brand, manufacturer and quality standard. If Eastman petg6763 is specified, recycle material, recycled material, etc. shall not be used.
Although the 21st CFR of FFDCA puts forward clear requirements for food packaging materials, due to the well-known reasons in the field of food safety in China, the development of food packaging industry is also morbid. At present, there are nearly ten thousand enterprises producing food packaging materials in China, with various products and large differences in production scale. There are many small-scale workshops. Food packaging in the market is full of industrial materials and recycled materials. In particular, a large number of harmful substances are released after UV sterilization, which is a threat to human health. Especially in recent years, food safety problems caused by food packaging materials emerge in endlessly, such as plastic packaging materials and film o-benzene plasticizer events, using RPET instead of APET and so on. The most obvious example is that the main raw material for the production of lunch box is polypropylene, but the manufacturer often adds industrial calcium carbonate as the filler in the production process. Because industrial calcium carbonate is a kind of powder with poor plasticity, it is difficult to glue the powder together when it is used in excess, so the lunch box produced is prone to quality problems such as soft and leakage. Therefore, the manufacturer must also add a special raw material - industrial paraffin. Industrial paraffin contains carcinogens, polycyclic aromatic hydrocarbons, easy to be consumed by consumers. Food grade blister box raw materials used in food are not yet passed, let alone used in the production of medical grade blister box with higher requirements?
3. Risks in mold and equipment technology
The medical blister box on the mold adopts aluminum mold, mainly made of ZL401, 6061 and 7075. However, 6061 is a better material in terms of overall mold processing accuracy and various properties, so 6061 aluminum is used for medical grade blister box mold. The mold making of food blister box varies from good to bad, including aluminum mold, copper mold, and even plastic mold when the production batch is small. In fact, the copper mold is the structure of internal powder and external copper, so the cleanliness can not meet the requirements of medical device packaging.
Large food grade blister box manufacturing enterprises generally use the integrated molding machine, and adopt the molding mode of low temperature and high speed up and down mold, with the advantages of large output and high efficiency, but the medical industry products are generally more varieties and less quantity. Although the integral forming machine feels that the shell of the product is hard, the physical properties of the product (such as anti drop) are relatively poor and easy to produce stress deformation. There is also a greater risk: due to the high efficiency of the integrated molding machine, and although there are measures to heat the cutter die in the punching section, there are still edge scurf flying out. Once entering the shell, it is difficult to use the lamp inspection table to check it out. If the self stacking blister box is disassembled for full inspection, it is easy to cause secondary scratches and affect the appearance quality (scratches are also one of the reasons for insoluble particles).
4. Risks in production environment
Medical grade blister box needs a clean workshop of 10000 ~ 100000 or higher. However, the production environment of food grade blister boxes is uneven. Some even 300000 grade clean workshops can not be guaranteed, but they all have QS certification. In addition, the medical grade blister box requires strict control of insoluble particles and initial contaminating bacteria in the production process. Especially the packaging of class III medical devices. However, the production environment of food grade blister box is far from meeting these requirements, because these quality control needs to have a professional laboratory, i.e. living bacteria operation room and microbial limit room. Also need to have a formal training of professional laboratory personnel and professional equipment to test. And these are food grade blister box can not match at present.