What are the commonly used sterilization methods for medical device blister packaging?

The complete medical device blister packaging consists 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 necessary to strictly control the packaging process. So, what are the commonly used sterilization methods for medical device blister packaging?

1, Sterilized by ethylene oxide (EO)

At present, ethylene oxide is widely used for sterilization of medical devices. .Ethylene oxide is a flammable and explosive toxic gas with a molecular formula of C2H4O and an aromatic ether smell. The relative density is 0.884 at 4°C, the boiling point is 10.8°C, and its density is 1.52g/cm3. At room temperature Under certain conditions, it is easy to volatilize into a gas, and when the concentration is too high, it can cause an explosion.

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

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

2. Irradiation Sterilization

Irradiation sterilization is to use the principle of nuclear radiation to cause the death of microorganisms by using the energy of atomic energy rays to achieve the purpose of sterilization. It has the advantages of complete sterilization, non-toxicity, green environmental protection, low energy consumption and energy saving. Commercially, cobalt-60 gamma rays and electron beams generated by electron accelerators are used for irradiation sterilization, which is often used for sterilization of dialyzers (the raw material of the product shell needs to be a radiation-proof grade of PC).

Irradiation sterilization is a destructive sterilization method. After sterilization of materials that cannot withstand irradiation sterilization, active free radicals will be generated and chemical reactions will occur, which will degrade the materials, and then turn yellow and brittle. , in order to make up for this defect, it is necessary to add more additives to the plastic to resist the influence of radiation. However, it is inevitable that the material itself will have a certain degree of desorption of small molecules, which will be adsorbed by the adsorbent or fiber membrane, and there is a risk of dissolution of more additives by the adsorbent or fiber membrane.

Irradiation is based on the principle of nuclear radiation, through gamma rays to sterilize the instruments, it is impossible to have no residue. Various countries around the world are still studying, and the possible residual substances include: radiation degradation or denatured substances of the material itself, and the residual radiation of nuclear radiation itself. The toxicity of these substances is still under study, and the type and amount of the remaining substances cannot be controlled.

3. Moist heat sterilization

The principle of moist heat sterilization is to deform the proteins and nucleic acids of microorganisms and cause them to die. This deformation is first of all the hydrogen bond in the molecule. When the hydrogen bond is broken, the internal structure of the protein and nucleic acid is destroyed, and then the original function is lost. It refers to the method of sterilization with saturated steam, boiling water or circulating steam, to High-temperature and high-pressure water vapor is used as the medium. Due to the large latent heat of steam and strong penetrating power, it is easy to denature or coagulate proteins, which will eventually lead to the death of microorganisms. Therefore, the sterilization efficiency of this method is higher than that of dry heat sterilization. It is a pharmaceutical preparation production process. The most commonly used sterilization method. Moist heat sterilization can be divided into: boiling sterilization, pasteurization, high pressure steam sterilization, circulating steam sterilization, and intermittent steam sterilization.

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