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What are the common sterilization methods for medical device blister packaging?

What are the common sterilization methods for medical device blister packaging?

  • Categories:News Center
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  • Time of issue:2019-04-22 12:10
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(Summary description)The complete medical device blister packaging is composed of two parts: PETG blister box + pre-coated Tyvek dialysis paper. Then, medical device blister packaging is a very important part of medical devices.

What are the common sterilization methods for medical device blister packaging?

(Summary description)The complete medical device blister packaging is composed of two parts: PETG blister box + pre-coated Tyvek dialysis paper. Then, medical device blister packaging is a very important part of medical devices.

  • Categories:News Center
  • Author:
  • Origin:
  • Time of issue:2019-04-22 12:10
  • Views:
Information

The complete medical device blister packaging is composed of two parts: PETG blister box + pre-coated Tyvek dialysis paper. Then, medical device blister packaging is a very important part of medical devices. In order to ensure the safety and effectiveness of medical device products, it is important to strictly control the packaging process. So, what kinds of sterilization methods are commonly used in medical device blister packaging?

 

 

 

1, ethylene oxide (EO) sterilization

 

 

 

Currently, medical devices are widely sterilized by using ethylene oxide. Ethylene oxide is a flammable and explosive toxic gas with a molecular formula of C2H4O and an aromatic etheric taste. The relative density is 0.884 at 4 ° C, the boiling point is 10.8 ° C, and its density is 1.52 g/cm 3 at room temperature. Under conditions, it is easy to volatilize into a gas, which can cause an explosion when the concentration is too high.

 

 

 

The advantage is: can kill all microorganisms, including bacterial spores, Mycobacterium tuberculosis, bacteria, viruses, fungi, etc.

 

 

 

Ethylene oxide does not damage the sterilized articles and has a strong penetrating power. Therefore, most articles that are not suitable for sterilization by the general method can be sterilized and sterilized by ethylene oxide. For example, electronic instruments, optical instruments, medical equipment, books, documents, fur, cotton, chemical fiber, plastic products, wood products, ceramics and metal products, endoscopes, dialyzers, and disposable medical supplies. Ethylene oxide is one of the most important methods of low temperature sterilization for medical device packaging.

 

 

 

2, irradiation sterilization

 

 

 

Irradiation sterilization uses the principle of nuclear radiation to cause microbial death by utilizing the energy of atomic energy rays to achieve the purpose of sterilization. It has the advantages of thorough sterilization, non-toxicity, environmental protection, low energy consumption and energy conservation. Commercially, the electron beam generated by cobalt-60 gamma ray and electron accelerator is used for irradiation sterilization, which is commonly used for the sterilization of dialyzers (the product of the outer casing of the product needs to use a radiation-proof PC).

 

 

 

Irradiation sterilization is a destructive sterilization method. After sterilization, materials that cannot withstand irradiation sterilization will produce active radicals and chemical reactions, which will degrade the material and turn yellow and become brittle. In order to compensate for this defect, it is necessary to add more additives to the plastic to resist the influence of the irradiation line. However, it is inevitable that the material itself will be decomposed to a certain extent by small molecules, so that it is adsorbed by the adsorbent or the fiber membrane, and more additives have the risk of being dissolved by the adsorbent or the fiber membrane.

 

 

 

Irradiation is based on the principle of nuclear radiation, and the device is sterilized by gamma rays. It is impossible to have no residue. Various countries around the world are still studying, and there may be residual substances: the radiation of the material itself is degraded or denatured, and the radiation of the nuclear radiation itself remains. The toxicity of these substances is still under investigation, and the types and amounts of the remaining substances are uncontrollable.

 

 

 

3, moist heat sterilization

 

 

 

The principle of moist heat sterilization is to deform the proteins and nucleic acids of microorganisms to cause their death. This deformation is firstly a hydrogen bond splitting in the molecule. When the hydrogen bond breaks, the internal structure of the protein and nucleic acid is destroyed, thereby losing the original function, and the method of sterilizing with saturated steam, boiling water or circulating steam is used. High-temperature and high-pressure water vapor is a medium. Due to the large latent heat of steam and strong penetrating power, it is easy to denature or solidify proteins, which ultimately leads to the death of microorganisms. Therefore, the sterilization efficiency of this method is higher than that of dry heat sterilization, which is the production process of pharmaceutical preparations. The most commonly used sterilization method. The moist heat sterilization method can be classified into a boiling sterilization method, a pasteurization method, a high pressure steam sterilization method, a flow steam sterilization method, and a batch steam sterilization method.

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