Definition of sterilization and sterilization method

Sterilization definition: refers to physical or chemical methods to kill or remove all pathogenic and non pathogenic microbial propagules and spores.

Sterilization method: refers to the method and technology to kill or remove all pathogenic and non pathogenic microbial propagules and spores.

The purpose of sterilization is to kill or remove all microbial propagules and spores, maximize the safety of the drug preparation, protect the stability of the preparation, and ensure the clinical efficacy of the preparation.

Classification of sterilization methods

Dry heat sterilization

Damp heat sterilization

Filtration sterilization

Radiation sterilization

1、 Definition of dry heat sterilization method

Definition: refers to the sterilization technology carried out in a dry environment.

2、 Mechanism of dry heat sterilization

The kinetic characteristics of dry heat sterilization and wet heat sterilization are similar, which conform to the "logarithmic rule", but the sterilization mechanism is different. Why is higher temperature required for dry heat sterilization?

Effect of moisture: low humidity

Different mechanisms: dry heat sterilization is to oxidize microorganisms rather than denature proteins

Characteristics: The medium for dry heat sterilization is usually hot air, which describes the microbial killing process with logarithmic rules. The accuracy is poor, the temperature is high, and the temperature is above 200 ℃. It is possible to reach 320 ℃ for the sterilization and heat removal of ampoules and vials in aseptic production processes such as glass containers and surgical instruments. dry

Thermal sterilization is classified into flame sterilization and dry hot air sterilization.

Flame sterilization method: refers to the method of direct burning with flame. Features: Sterilization is fast, reliable and simple. It is applicable to the sterilization of articles and appliances made of flame resistant materials (such as metal, glass, porcelain, etc.), but generally not suitable for the sterilization of drugs. Dry hot air sterilization method: refers to using high temperature

Dry hot air sterilization method. Features: This method is applicable to the sterilization of high-temperature resistant metal, glass, and other articles and appliances, as well as grease (such as oily ointment matrix, oil for injection, etc.) that does not allow moisture penetration, and high-temperature resistant powder chemicals, and is not suitable for rubber

Sterilization of plastics and most drugs. It should be noted that in the dry state, due to the poor heat penetration and strong heat resistance of microorganisms, the sterilization can be achieved only after being subjected to high temperature for a long time. Therefore, the temperature used for dry hot air sterilization is generally higher than that used for wet heat sterilization

The law is higher. Generally, it is required to sterilize for 3-5 hours at 135-145 ℃; Sterilization at 160-170 ℃ for 2-4 hours; Sterilize at 180-200 ℃ for 0.5-1 hour.

3、 Definition of moist heat sterilization method: refers to the method of sterilization with saturated steam, boiling water or circulating steam. In fact, as long as the microorganism is in the sterilization process under the condition of water steam balance, it is moist heat sterilization. The wet heat sterilization method is characterized by strong steam heat penetration and sterilization efficiency

High temperature, relatively low temperature, relatively short sterilization time, no chemical and physical pollution during the sterilization process, few control parameters of the sterilization equipment, stable operation, and convenient management of the most commonly used methods in the pharmaceutical preparation production process.

4、 Classification of moist heat sterilization

Autoclaving

Circulating steam sterilization

Boiling sterilization

Low temperature intermittent sterilization

Hot pressure sterilization method for moist heat sterilization

The advantage of dry heat sterilization is that bacteria can be directly killed under dry heat conditions. The method of killing bacteria by using dry hot air or flame to coagulate the protoplasm of bacteria and destroy the enzyme system of bacteria. It is mainly used for sterilization of containers and appliances. Suitable for high temperature resistant glass, metal, etc

With. However, moist heat sterilization requires heating water to a certain temperature under wet conditions before bacteria die.

Anqing P&G Packaging Co., Ltd., as a high-quality supplier of medical packaging materials in the country, currently has more than ten machines to support the production of self-adhesive dry heat sterilization bags. It is one of the few professional source manufacturers in the country. In 2008, the company was established in accordance with ISO13485:2003

The quality management system of international standard has been certified by T ｜ V notified body in South Germany. The possession and utilization of these hardware and software have played an active role in realizing the company's business purpose of "ensuring product quality and safety and creating value for customers" in the subsequent production and operation process,

It has also laid a solid foundation for the company's production and operation performance. Now the company has more than ten production lines, including full-automatic bag making machine, flexographic printing machine, gravure printing machine, gluing compound machine, slitting machine, pallet forming machine, and has formed a monthly production of 5 million square meters of various medical packaging bags

The annual sales volume reaches 70 million yuan and the annual export volume reaches 10 million dollars.