Key points of knowledge
Plastic thermoforming
A plastic processing technology, commonly known as blister in China. The main principle is to heat and soften the plastic coiled material, and then use vacuum to absorb it on the surface of the mold. After cooling, it is formed. The main advantages of thermoforming packaging are convenient transportation, good sealing performance, and it can package any special-shaped products. The packaged products are transparent and visible, beautiful in appearance, and easy to sell. For the medical device industry, the packaging produced by this process is generally called hard blister box. The protection function, appearance beauty, product positioning, etc. of hard blister box are higher than those of soft packaging products. Developed countries have become the mainstream packaging trend of medical devices. It is generally matched with hard blister box+cover material. The cover materials mainly include: pre coated Teweiqiang, medical dialysis paper, film with special easy peeling coating, etc.
Features of hard blister box
For general products, the packaging is just to include the product, so as to protect the product and make it beautiful and generous; However, for medical device packaging, it also needs to consider the following points
1. It is required to provide protection, identification, proprietary performance, ease of use and special applications for the use and display of devices;
2. It is necessary to have a comprehensive understanding of the use, size, shape of the product and its proprietary features (such as sharp edges, sharp points, brittleness, etc.), distribution environment, application (convenient for medical personnel to open cleanly) and barrier requirements, which are very important for selecting appropriate materials and successfully designing the final packaging.
Therefore, the protection performance of medical hard blister box is more extensive:
1. Sterilization: the device can be finally sterilized in one or more ways, and the material will not be degraded within the specified time;
2. Shelf life: ensure the stability of the so-called barrier of materials throughout the life cycle of the product;
3. Environment: isolate water, air, bacteria and oxygen;
4. Physical aspects: it can provide dynamic protection, resist impact and wear, and provide structural support.
Microorganism: a large class of biological groups including bacteria, viruses, fungi and some small protozoa, which are small and closely related to human life. It is widely involved in health, medicine, industry and agriculture, environmental protection and many other fields. Microbes are divided into the following 8 categories: bacteria, viruses, fungi, actinomycetes, rickettsia, mycoplasma, chlamydia and spirochetes.
Species: eukaryotic, prokaryotic, and non cellular
Features: small, simple and low
Aseptic packaging：无菌包装是对初始污染菌实施严格控制的包装。将细菌内毒素含量限制在规定范围内，以实现医疗器械无热源反应的目的。热源是由内毒素引起的，内毒素是革兰氏阴性细菌细胞壁中的一种成分，叫做脂多糖。脂多糖对宿主是有毒性的。内毒素只有当细菌死亡溶解或用人工方法破坏菌细胞后才释放出来，所以叫做内毒素。它们广泛存在于水、原料、人和生产环境中的细菌体内，在其死亡的瞬间产生，轻者引起人体发热、严重时可导致人死亡。
Clean opening：有明显的产品取出位，产品方便从包装中取出，产品不易破损。保证医生或最终使用者做到洁净开启无菌取出非常关键，否则之前所有的努力都会归零。不论你使用透析纸还是特卫强，都要考虑与硬吸塑盒的封合。当然，封合设备、热合模具等都会成为洁净开启的影响因素。
Insoluble particle：是指在生产或应用中经过各种途径污染的微小颗粒杂质，其粒径在1微米~50微米之间，是肉眼不可见、易动性的非代谢性的有害粒子。大量的动物试验和人体解剖证明，不溶性微粒会产生一时难以发现的、潜在的严重危害。不溶性微粒的存在可以导致动脉炎、微血栓或异物肉芽肿等，严重的同样会危及生命。通常采用光阻法（LightObscurationParticlesCountTest）和显微计数法(MicroscopicParticlesCountTest)检测。
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