TECHNICAL

 It is a kind of plastic processing technology, which is commonly known as the blister in China. The main principle of this technology is to heat and soften the plastic coiled materials and then adopt the vacuum method to adsorb it on the mould surface to shapeafter cooling. The main advantages of thermoforming packaging include convenient transportation, good sealing performance, and ability to pack any special-shaped product. The products to be packed can be clearly seen from outside, which provides beautiful appearances, and hence convenient for sales. For the industry of medical apparatus and instruments, the packages produced by using this technology are generally called hard blister boxes, whose protection function, aesthetic appearance, and product positioning are all higher than those of flexible packaging products. In developed countries, hard blister boxes have become a mainstream trend of packaging in medical apparatus and instruments. Generally, the combination is “hard blister box + cover material”, with the cover material basically including pro-gluing TYVEK, medical dialysis paper, membrane with special easy stripping coating, and etc.

 

       
 

Features of hard blister box

For ordinary products, packaging is just to contain the products inside and provides protection and add beauty to products. However, for the packaging of medical apparatus and instruments, the following should also be taken into account: to provide protection and identification for the use and display of medical apparatus and instruments, as well as proper performance, convenience of use, and special applications; to fully understand the usage, size, shape, and distinguished characteristics (e.g. sharp edges, sharp points, brittle, etc.), distribution environment, application (convenient for medical personnel to clean open) and blocking requirements of the product, which is very important for choosing appropriate materials and successfully designing the final packaging. Therefore, the protection performances of medical hard blister boxes are wider:  Sterile: able to adopt one or more ways to achieve final sterilization for medical apparatus and instruments, without being degraded within the prescribed time;  Shelf life: ensure the stability of the so-called barrier of materials in the whole life cycle of the products;  Environmental aspect: isolate the products from water, air, bacteria, and oxygen;  Physical aspect: able to provide dynamic protection, resistance to impact and abrasion, and provide structural support.

Microorganism:Including a whole family of biological groups such as bacteria, viruses, fungi and some small protozoa, which are individually small, but closely related to human life. It is widely involved in health, medicine, agriculture and industry, environmental protection, and many other fields. Microbes are divided into the following eight categories: bacteria, viruses, fungi, actinomyces, rickettsia, mycoplasma, chlamydia, and helix. Categories: eukaryotic, prokaryotic, and acellular. Features: small, simple, and low;

 

          
 

Sterile packaging: Sterile packaging provides strict control of initial contaminating bacteria, which limits the bacterial endotoxin content to the stipulated scope, in order to achieve the purpose of no pyrogen reaction of medical apparatus and instruments. Pyrogen is caused by endotoxin, which is a component of the the gram-negative bacteria cell wall called lipopolysaccharide. Lipopolysaccharide is toxic for the host. Endotoxin can only be released when the bacteria dies and dissolves or its bacteria cell is destroyed by using artificial methods, which is so called endotoxin. They exist widely in the bacteria in the water, raw materials, and production environment and are generated at the moment of death. In less severe cases, they can cause fever to human bodies; while death may occurin severe cases.

Clean opening:With clear instructions on take-out positions, the products can be taken out from the packages conveniently without being damaged. It’s very critical to ensure that doctors or end users can easily fulfill sterile clean opening, otherwise all the previous efforts will be in vain. No matter whether you use dialysis paper or TYVEK, consider sealing it with the hard blister boxes. Of course, sealing devices, thermal-sealing moulds and others will be the influence factors of clean opening.

Insoluble particles: referring to the tiny molecule impurities contaminated through various ways during production and application, with the diameter between 1μm - 50μm. These particles are not visible to naked eyes and easy to move, and they are non-metabolic, harmful particles. A large number of animal experiments and human anatomy showed that insoluble particles will bring serious potential harm which is hard to find for a short while. The existence of insoluble particles can cause arteritis, micro thrombus or foreign body granuloma, which also can endanger life in serious cases. Usually, they are detected by using the photoresist method (Light Obscuration Particles Count Test) and Microscopic Particles Count Test.

 

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