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

Sterile packaging：Sterile packaging is packaging that strictly controls the initial contaminating bacteria. Limit the content of bacterial endotoxin within the prescribed range to achieve the goal of no reaction of pyrogen in medical devices. Pyrogen is caused by endotoxin, which is a component in the cell wall of Gram-negative bacteria called LSP（lipopolysaccharide）. LSP is toxic to the host. Endotoxin is only released when bacteria die, dissolve or when bacterial cells are artificially destroyed, which is why it is called endotoxin. They are widely present in bacteria in water, raw materials, people and production environments, and are produced at the moment of their death. In mild cases, they cause fever in the human body, and in severe cases, they can lead to death. 

Clean opening：There is a clear product removal position, making it convenient to take the product out of the packaging and the product is less likely to be damaged. It is crucial to ensure that doctors or end users can clean, open and remove it aseptically; otherwise, all previous efforts will be in vain. Whether you use dialyzing paper or Tyvek, you should consider the sealing with the hard blister box. Of course, sealing equipment, heat sealing molds, etc. will all be influencing factors for clean opening.

Insoluble particle：It refers to the tiny particle impurities that are contaminated through various channels during production or application, with particle sizes ranging from 1μm to 50 μm. These are invisible to the naked eye, movable, and non-metabolic harmful particles. A large number of animal experiments and human dissections have proved that insoluble particle can cause potentially serious hazards that are difficult to detect for the time being. The presence of insoluble particle can lead to arteritis, microthrombosis or foreign body granuloma, etc. In severe cases, it can also be life-threatening. We usually adopt the Light Obscuration Particles Count Test and Microscopic Particles Count Test detection.