NEWS CENTER

/
/
/
What are the common sterilization methods for medical packaging?

What are the common sterilization methods for medical packaging?

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

(Summary description)This method refers to a method in which a sterilized article is placed in an electron beam generated by a suitable radiation source or an electron beam generated by a suitable electron accelerator to perform ionizing radiation to kill microorganisms.

What are the common sterilization methods for medical packaging?

(Summary description)This method refers to a method in which a sterilized article is placed in an electron beam generated by a suitable radiation source or an electron beam generated by a suitable electron accelerator to perform ionizing radiation to kill microorganisms.

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

Radiation sterilization

 

This method refers to a method in which a sterilized article is placed in an electron beam generated by a suitable radiation source or an electron beam generated by a suitable electron accelerator to perform ionizing radiation to kill microorganisms. This method is most commonly used for 60Co-gamma ray radiation sterilization. Medical devices, containers, production aids, bulk drugs that are not damaged by radiation, and finished products can be sterilized by this method.

 

 

Products that have been sterilized by radiation sterilization should have a SAL of 10-6. The parameters controlled by gamma ray sterilization are mainly the radiation dose (refers to the absorbed dose of the sterilized article). The dosage should be formulated in consideration of the suitability of the sterilized article and the maximum number of microorganisms that may be contaminated and the strongest radiation resistance. It should be verified in advance that the dose used does not affect the safety, effectiveness and stability of the sterilized article. The commonly used radiation sterilization absorption dose is 25KGy. The final product, API, and certain medical equipment should be sterilized by low-radiation dose as much as possible. Before sterilizing, the amount of microbial contamination of the sterilized article and the radiation resistance should be measured to evaluate the sterility assurance level given to the sterilized article by the sterilization process.

 

 

When sterilizing, the radiation dose absorbed by the sterilized articles should be monitored by appropriate chemical or physical methods to fully confirm that the absorbed dose of the sterilized articles is within the specified limits. If a radioactive dosimeter that is irradiated with a sterilized item is used, the dosimeter should be placed at the specified location. The dosimeter is calibrated using a standard source at the initial installation and recalibrated periodically.

 

 

 

Dry heat sterilization

 

 

 

This method refers to the method of placing the articles in a dry heat sterilization cabinet, a tunnel sterilizer, etc., using dry hot air to kill microorganisms or eliminate pyrogens. It is suitable for sterilization of articles that are resistant to high temperature but not suitable for sterilization by damp heat sterilization. For example, glassware, metal containers, fiber products, solid reagents, liquid paraffin, etc. can be sterilized by this method.

 

 

 

Dry heat sterilization conditions are generally 160 ~ 170 ° C * 120min or more, 170 ~ 180 ° C * 60min or more or 250 ° C * 45min or more, other temperature and time parameters can also be used. SAL "10-6. Dry heat The SAL of the item after excessive killing should be “10-12. At this time, the item generally does not need to be tested for contaminating microorganisms before sterilization. Dry heat sterilization at 250 ° C * 45 min can also remove the aseptic product packaging container and the pyrogens in the production of filling equipment.

 

 

 

When dry heat sterilization is used, the sterilized articles should be properly loaded and cannot be arranged too densely to ensure the effectiveness and uniformity of sterilization.

 

 

 

The dry heat sterilization method should confirm that the temperature distribution in the sterilizer meets the set standards and determines the coldest point position. A commonly used biological indicator is the Spores of Bacillus subtilis. The bacterial endotoxin inactivation verification test is a test to demonstrate the effectiveness of the pyrogen process. Typically less than 1000 units of bacterial endotoxin is added to the item to be depyrogenated, demonstrating that the depyrogenation process reduces endotoxin by at least 3 log units. The bacterial endotoxin used in the bacterial endotoxin inactivation verification test is generally Escherichia coli endotoxin.

 

 

 

Wet heat sterilization

 

 

 

This method refers to a method in which a product is placed in a pressure steam sterilizer by means of high-pressure saturated steam or superheated water spray to denature proteins and nucleic acids in the microbial cells to kill microorganisms. The method has strong sterilization ability and is the most effective and widely used sterilization method in heat sterilization. Drugs, containers, culture media, sterile clothing, rubber stoppers, and other items that do not change or be damaged by heat and humidity can be sterilized by this method. Circulating steam can not completely kill bacterial spores, and can generally be used as an auxiliary sterilization method for heat-resistant sterile products.

 

 

 

The moist heat sterilization conditions usually use 121 ° C * 15 min, 121 ° C * 30 min, or 116 ° C * 40 min procedures, other temperature and time parameters can also be used, but the SAL "10-6 after sterilization of the articles must be guaranteed. For heat-stable products, the overkill method can be used, and the SAL should be “10-12. The standard sterilization time F0 of the product with poor thermal stability [refers to the sterilization temperature is 121 ° C, the D value of the biological indicator bacteria is 1 point, and the sterilization temperature coefficient Z value is 10.0 ° C. The equivalent inactivation rate of microorganisms calculated at 121 ° C) is generally not lower than 8 min. If the thermal stability of the product is very poor, the F0 of the moist heat sterilization can be allowed to be less than 8. In this case, the contaminated microorganisms in the product should be strictly monitored during the whole production process, and various measures should be taken to reduce microbial contamination. Level to ensure that the sterilized product meets the sterility assurance requirements.

 

 

 

When using moist heat sterilization, the sterilized articles have an appropriate loading method and cannot be arranged too densely to ensure the effectiveness and uniformity of sterilization.

 

 

 

The moist heat sterilization method should confirm the cold spots that may exist in the sterilizer at different loadings. When the biological indicator is used to further confirm the sterilization effect, it should be placed at a cold spot. The biological indicator of the method is a spore of Bacillus stearothermophilus.

 

 

 

Ethylene oxide sterilization

 

 

 

Ethylene oxide, also known as ethylene oxide, is a colorless liquid at low temperature, has an aromatic ether flavor, a boiling point of 10.8 ° C, an odor threshold of 760 mg / m ~ 1064 mg / m, a density of 1.52; ethylene oxide flammable Explosion, its minimum combustion concentration is 3%. Ethylene oxide gas has a strong penetrating power.

 

 

 

Ethylene oxide gas has strong bactericidal power and wide spectrum of sterilization, and can kill various microorganisms including bacterial spores, and is a sterilizing agent. 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 currently one of the most important methods of low temperature sterilization.

 

 

 

Ozone sterilization

 

 

 

Ozone is a strong oxidant and the sterilization process is a biochemical oxidation reaction. O3 sterilization has the following three forms:

 

 

 

Ozone can oxidize the enzymes needed to break down the internal glucose of bacteria, killing bacteria and killing them.

 

 

 

Directly interact with bacteria and viruses, destroying their organelles and DNA, RNA, destroying the metabolism of bacteria, leading to bacterial death.

 

 

 

Through the cell membrane tissue, invading the cells, acting on the outer membrane of lipoproteins and internal lipopolysaccharides, causing the bacteria to undergo permeability distortion and dissolve and die.

 

 

 

The speed and effect of ozone sterilization are unparalleled. Its high oxidation-reduction potential determines its wide application in oxidation, decolorization and deodorization. Some people have pointed out that ozone dissolves in water and can kill almost all harmful substances in the water. For example, iron, manganese, chromium, sulfate, phenol, benzene, oxides, etc., can also decompose organic matter and kill algae.

 

 

 

The ozone disinfection method has the following characteristics compared with the conventional sterilization method:

 

 

 

(1) High efficiency. Ozone disinfection is based on air and does not require any other auxiliary materials and additives. The body is well inclusive, thoroughly sterilized, and has a strong function of removing odor, such as mildew, cockroach and odor.

 

 

 

(2) High cleanliness. The rapid decomposition of ozone into oxygen is a unique advantage of ozone as a sterilization. Ozone is produced by using oxygen in the air. During the disinfection process, excess oxygen is combined into oxygen molecules after 30 minutes, and there is no residue, which solves the secondary pollution problem caused by the disinfectant disinfection method, and saves the problem. Clean again after disinfection.

 

 

 

(3) Convenience. Ozone sterilizers are typically installed in clean rooms or in air purification systems or in sterilization rooms (eg, ozone sterilizers, transfer windows, etc.). According to the sterilization concentration and time of the debugging verification, the time and opening time of the sterilizer are set, and the operation is convenient.

 

 

 

(4) Economics. Compared with the use and operation of many pharmaceutical industries and medical and health units, ozone disinfection methods have great economic and social benefits compared with other methods. In today's rapid industrial development, environmental issues are particularly important, while ozone disinfection avoids secondary pollution from other sterilization methods.

Scan the QR code to read on your phone

©2019 Taishan Xin Hua Pharmaceutical Packaging Co., Ltd.   粤ICP备19044078号  Powered by www.300.cn