Final sterilization preparation is the last step of finished product sterilization, which can be carried out in a non-sterile environment.
Non-final sterilization preparations are required to be operated in a sterile environment during production.
2. The physical properties of reagents are different.
The product of the final sterilization preparation is heat-resistant and can be directly sterilized.
Products that are not final sterilization preparations are not heat-resistant and cannot be directly sterilized.
Extended data:
Sterilization method:
There are two common sterilization methods in the production of sterile preparations and drugs: physical sterilization and chemical sterilization. Physical sterilization includes heating, radiation, filtration, etc. Chemical sterilization is a method of sterilizing drugs and materials with chemical gas or steam.
The selection of sterilization equipment should be determined according to the manufacturing process of sterile drugs, such as aseptic manufacturing and final sterilization manufacturing. Different manufacturing processes have different sterilization processes.
1, moist heat sterilization?
Strong bactericidal ability, the most effective and the most widely used. Generally suitable for sterilization of heat-resistant drugs, containers, culture media, sterile clothes, rubber stoppers and other items that will not change or be damaged in high temperature and high humidity environment.
Molding equipment includes vertical sterilizer, desktop pressure steam sterilizer, pulsating vacuum sterilizer, Chinese patent medicine sterilizer, multifunctional ampoule leak detection sterilizer, large infusion water bath sterilizer, etc.
2. Does dry heat kill bacteria?
It can remove pyrogen, and is suitable for articles that are resistant to high temperature but not suitable for moist heat sterilization, such as metal containers, fiber products, solid reagents, liquid paraffin, glass instruments, etc. Molding equipment includes Shuang Ye oven, penicillin bottle tunnel sterilizer, etc.
3. radiation sterilization?
The most commonly used method is 60Co-Y radiation sterilization. Suitable for medical instruments, containers, production AIDS, raw materials and finished products that are not damaged by radiation. The radiation dose should be controlled.
4, gas sterilization method
Commonly used chemical disinfectants are ethylene oxide, gaseous hydrogen peroxide, formaldehyde and ozone. Suitable for disinfection and sterilization of articles that are stable in selected gases. Attention should also be paid to the flammability, explosiveness, teratogenicity and residual toxicity of sterilization gas. When using ethylene oxide, leakage test should also be considered.
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