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Difference between sterile plastic box and food grade

In the blister box products, medical aseptic packaging and food grade belong to the jurisdiction of food and drug administration. This paper will evaluate the irreplaceable of the two from the perspective of risk management.


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. The packaging material manufacturers in the food industry need to pass QS certification, 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 material, which meets 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.


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. And 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 inner powder and outer copper, so the cleanliness can not meet the requirements of medical equipment packaging.


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 plastic box is far from these requirements, because these quality control needs to have a professional laboratory, namely, the living bacteria operating room and the 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.


5. Risks in relevant experiments and packaging verification:

The packaging validation of medical devices is different from that of food or other industrial products. The packaging validation of medical devices has a designated authoritative Safety Assessment Laboratory and institution, which can scientifically and efficiently evaluate the safety and effectiveness of the packaging Blister box of medical devices. From the biocompatibility and toxicological characteristics, physical and chemical properties of raw materials, to the adaptability to the molding and sealing process of the blister box, to the adaptability to the expected sterilization process, the expected design validity period, the transportation mode, etc., to the microbial barrier of the whole packaging system, there are strict verification procedures and requirements of laws and regulations. And these professional packaging verification is the lack of food packaging industry.

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