Why can't food-grade blister boxes replace medical-grade bli
Release: Hexiang Packaging??Time：2021-09-14Among blister products, medical aseptic packaging and food grade are both under the jurisdiction of the Food and Drug Administration. This article will assess how irreplaceable the two are from the perspective of risk management.
1. About Access Approval and Certification
Internationally, food packaging needs to pass ISO22000, while medical device packaging needs to pass ISO13485. Although it is a third-party certification, the difference is mainly in material verification and sterilization requirements. And the requirements for medical packaging verification and batch consistency will be higher. In China, the medical industry is also following up further and converging with the international community. Originally, packaging material manufacturers were not required to provide ISO13485 certification, which is now also a recommendation. Although there is no registration system for the identification of packaging material manufacturers, it puts the risk on the device manufacturer. Packaging materials in the food industry require QS certification from packaging material manufacturers, which is a government-led certification system.
2. Risk from raw materials
The choice of materials is a prerequisite for quality assurance. The requirements for raw materials of medical grade blister boxes are medical grade. The control and requirements from the initial raw material particles to the forming sheet are much higher than that of food-grade blister boxes. The most basic requirements for the selection of medical blister boxes are environmentally friendly sheets that meet ISO10993 and ISO11607 certification and can meet microbial barrier protection, excellent sterilization methods, biocompatibility, and prevention of related infections (HAI). For example, Class III medical blister boxes basically specify the material grade, manufacturer and quality standard selected by the manufacturer. If Eastman PETG6763 is specified, recycled materials, recycled materials, etc. cannot be used.
Although the US FFDCA Code of Federal Regulations Volume 21 (CFR) puts forward clear requirements for food packaging materials, the development of the food packaging industry has also become pathological due to well-known reasons in the food safety field in my country. At present, there are nearly 10,000 companies producing food packaging materials across the country, with a wide variety of products and large differences in the scale of production. There are many small-scale workshop-style production companies. Food packaging on the market is flooded with industrial materials and recycled materials. Especially for the recycled materials, a large amount of harmful substances are precipitated after ultraviolet sterilization, which poses a threat to human health. Especially in recent years, food safety problems caused by food packaging materials have emerged one after another, such as the incident of phthalic plasticizers in plastic packaging materials and films, and the use of RPET instead of 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, its plasticity is relatively poor, and the powder is difficult to stick together when it is used in excess, so the produced lunch boxes are prone to quality problems such as softness and leakage. Therefore, manufacturers must also add a special raw material-industrial paraffin. Industrial paraffin contains carcinogens and polycyclic aromatic hydrocarbons, which are easily eaten by consumers. The raw materials of food-grade blister boxes are not approved for use in food, let alone the production of more demanding medical-grade blister boxes?
3. Risks in mold and equipment process
The medical blister box on the mold is made of aluminum mold, and the materials are mainly ZL401, 6061 and 7075. But in terms of overall mold processing accuracy and various properties, 6061 is a better material, so 6061 aluminum is used for the molds of medical-grade blister boxes. The molds for food blister boxes are unevenly made, such as aluminum molds and copper molds, and even plastic molds are used when the production batch is small. The copper mold is actually a structure of inner powder and outer copper, and the cleanliness cannot meet the requirements of medical device packaging.
Larger food-grade blister box manufacturers generally use integrated molding machines, using low-temperature and high-speed up and down molding methods. Large output and high efficiency are their advantages. However, the medical industry products generally have more varieties and fewer quantities. Although the product feels that the shell of the integral molding machine is hard, the physical properties of the product (such as drop resistance) are relatively poor and are prone to stress deformation. There is also a bigger risk: due to the high efficiency of the integrated molding machine, even though the die cutting section has measures to heat the die, there is still edge lint flying out. Once it enters the shell, it is difficult to use the lamp inspection table to inspect it. . If the automatically stacked blister box is disassembled and inspected, 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 the production environment
Medical-grade blister boxes require a clean workshop of 10,000-100,000 or higher. However, the production environment of food-grade blister boxes is uneven, and some of them cannot even guarantee a clean workshop of 300,000 grade, but they all have QS certification. In addition, the medical-grade blister box requires strict control of insoluble particles 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 controls require professional laboratories, viable bacteria operating rooms and microbial limit rooms. It is also necessary to have formal training of professional laboratory personnel and professional equipment for testing. These are what food-grade blister boxes are currently unattainable.
5. Risks in related experiments and packaging verification
The verification of packaging for medical devices is different from the verification of packaging for food or other industrial products. Medical device packaging verification has designated authoritative safety assessment laboratories and institutions, which can scientifically and efficiently evaluate the safety and effectiveness of medical device packaging blister boxes.
From the biocompatibility and toxicological properties, physical and chemical properties of the raw materials, to the adaptability to the forming and sealing process of the blister box, to the adaptability to the expected sterilization process, the expected design validity period, the mode of transportation, etc., up to the whole The microbial barrier of the packaging system has strict verification procedures and requirements of laws and regulations. These professional packaging verifications are what the food packaging industry lacks.
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 specifically manifested in the lack of standards, overlaps, and conflicts between hygienic quality standards and industry standards. Not to mention replacing 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, then medical devices packaged in a food-grade blister box may become a lethal weapon, not rescuing the patient, but becoming a “killer” Sharp weapon.
The packaging of medical devices is a life barrier. The selection of packaging materials, structural design, process execution, and packaging experimental inspections are all critical. And not only the chemical and physical properties of packaging materials must be considered, but also the process verification of sterilization packaging. That is to consider the initial, sterilized and accelerated aging performance. Choosing packaging that meets sterile requirements is an inevitable choice for medical device manufacturers. The concept of adapting to sterilization technology is the supreme guarantee for medical device products.
