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Home >> News >>Product Knowledge >> What are the commonly used sterilization methods for blister packaging of medical instruments?

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

Time:2022-04-07     Author:YangZhiGuang【Original】

  The complete blister packaging of medical devices is composed of two parts:PETG blister box+precoated Tyvek dialysis paper.So,blister packaging for medical devices is a very important part of medical devices.In order to ensure the safety and effectiveness of medical devices,the packaging process must be strictly controlled.So,what kinds of sterilization methods are commonly used for blister packaging of medical instruments?

  1,ethylene oxide(EO)sterilization

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

  Advantages are:can kill all microorganisms,including bacterial spores,tuberculosis bacilli,bacteria,viruses,fungi and so on.

  Ethylene oxide does not damage the sterilized articles and has strong penetration,so most of the articles that are not suitable for sterilization by general methods can be sterilized and sterilized by ethylene oxide.For example,electronic instruments,optical instruments,medical instruments,books,documents,fur,cotton,chemical fiber,plastic products,wood products,ceramic and metal products,endoscope,dialyzer and disposable medical supplies.Ethylene oxide is one of the main low temperature sterilization methods for blister packaging of medical instruments.

Blister packaging for medical instruments

  2.Irradiation sterilization

  Irradiation sterilization,is the use of nuclear radiation principle through the use of atomic radiation energy caused by the death of microorganisms,so as to achieve the purpose of sterilization,with thorough sterilization,non-toxic,green environmental protection,low energy consumption,energy saving advantages.Commercial use of cobalt-60γray and electron beam produced by electron accelerator to carry out irradiation sterilization,often used for the sterilization of dialyzer(product shell raw materials need to use anti-radiation PC).

  Irradiation is based on the principle of nuclear radiation,through theγray disinfection and sterilization of equipment,no residue is impossible.Various countries around the world are still in the study,the possible residual substances are:the material itself radiation radiation degradation or denatured material,nuclear radiation radiation itself residue.The toxicity of these substances is still under study,and the type and amount of the substances left can not be controlled.

Blister packaging for medical instruments

  3.Damp heat sterilization

  The principle of damp-heat sterilization is to deform the protein and nucleic acid of microorganism,leading to its death.This kind of deformation is molecular hydrogen bonds in the first division,when hydrogen bond rupture,protein and nucleic acid structure was destroyed,and then lost the original function,refers to the use of saturated steam and boiling water or circulation of steam sterilization method,with high temperature and high pressure steam as medium,because of the large latent heat of steam,strong penetrating power,easy to make protein denaturation or solidification,eventually killing microorganisms,Therefore,the sterilization efficiency of this method is higher than that of dry heat sterilization,and it is a commonly used sterilization method in the production of pharmaceutical preparations.Damp heat sterilization method can be divided into:boiling sterilization method,pasteurization method,high-pressure steam sterilization method,circulation steam sterilization method,and intermittent steam sterilization method.

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