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Pharmacology (Sterilization and Aseptic Operation)
Pharmacy, Ninth Edition, Chief Editor Fang Liang, Chapter 9 Unit Operations of Liquid Preparations, Section 3 Sterilization and Aseptic Operations, including physical sterilization methods, chemical sterilization, Aseptic operation methods, etc.
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Pharmacology (Sterilization and Aseptic Operation)
- bacteria
This is a mind map about bacteria, and its main contents include: overview, morphology, types, structure, reproduction, distribution, application, and expansion. The summary is comprehensive and meticulous, suitable as review materials.
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- Reproductive development of animals
This is a mind map about the reproductive development of animals, and its main contents include: insects, frogs, birds, sexual reproduction, and asexual reproduction. The summary is comprehensive and meticulous, suitable as review materials.
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- Outline
Sterilization methods and aseptic operations
1. Physical sterilization method
It is a method that utilizes the unstable properties of proteins and nucleic acids when exposed to heat and radiation, and uses heating, radiation and filtration methods to kill or remove microorganisms.
(1) Moist heat sterilization method (this method has strong sterilization ability and is the most effective and widely used sterilization method in thermal sterilization)
1. Autoclave sterilization method
A method of killing microorganisms by heating with high-pressure saturated water vapor.
The most widely used
This method has high sterilization temperature, good sterilization effect, and can kill all microbial propagules and spores.
Usually 126℃, 15 minutes, 121℃, 30 minutes or 116℃, 40 minutes
2. Circulation steam sterilization method
Under normal pressure, use 100℃ circulating steam to heat and kill microorganisms
As an auxiliary sterilization method for heat-labile sterile products
3. Boiling sterilization method
100℃, boiling time is usually 30 to 60 minutes
The sterilization effect is poor and all spores are not guaranteed to be killed.
4. Low temperature intermittent sterilization method
Place the object to be sterilized in water or circulating steam at 60 to 80°C and heat it for 1 hour. After killing the microbial propagules, place it at room temperature for 24 hours. When the spores develop into propagules, heat, sterilize and place it again for many times. , until all spores are killed.
Suitable for sterilization of materials and preparations that are not resistant to high temperatures and are heat-sensitive
Disadvantages: time-consuming and low sterilization efficiency
(2) Dry heat sterilization method
Refers to the method of heat sterilization in a dry environment.
1. Flame sterilization method
Direct flame sterilization method.
Suitable for sterilizing items and utensils made of refractory materials (such as metal and glass)
Not suitable for pharmaceutical sterilization
2. Dry hot air sterilization method
Refers to the method of using dry hot air to kill microorganisms or eliminate pyrogens.
It is suitable for sterilizing items that are resistant to high temperatures but are not suitable for sterilization by moist heat sterilization, such as glassware, metal containers, ceramic products, and greases that do not allow moisture to penetrate (such as oily ointment bases, injection oils, etc.)
Dry hot air sterilization usually uses 160~170℃ for more than 2 hours, 170~180℃ for more than 1 hour or 250℃ for more than 45 minutes (pyrogen can also be removed).
(3) Ray sterilization method
1. Radiation sterilization method
Commonly used radiation rays include γ rays produced by the decay of ∧66Co or ∧137Cs, electron beams produced by electron accelerators, and X-rays produced by X-ray devices.
It does not increase product temperature, has strong penetrating power, high sterilization efficiency and wide application range.
Suitable for sterilization of heat-sensitive materials and preparations, medical equipment, production auxiliary supplies, pharmaceutical packaging materials, etc.
2. Ultraviolet sterilization method
The wavelength of ultraviolet rays used for sterilization is generally 200 to 300nm, of which 254nm has the strongest sterilization power.
It is mainly used for air sterilization in clean rooms and sterilization of object surfaces. It cannot be used for deep sterilization of ampoules of Chinese medicinal liquids and solid materials.
3.Microwave sterilization method
Suitable for sterilization of liquid and solid materials, and has drying effect on solid materials
(4) Filtration sterilization method
It is a method of removing microorganisms by using the interception effect of filter materials.
Filters with an absolute pore size of 0.22 μm are commonly used for sterilization filtration, which can remove all microorganisms except viruses. (or No. 6 glass vertical melt filter)
2. Chemical sterilization method
Refers to the method of using chemicals to directly kill microorganisms. This method is only effective against microbial propagules and cannot kill spores.
(1) Gas sterilization method
The most commonly used sterilizing agent is ethylene oxide, which is generally mixed with 80% to 90% inert gas and carried out in a high-pressure chamber filled with sterilizing gas.
This method is not applicable to the sterilization of medical devices, plastic products and pharmaceutical packaging materials that are not resistant to radiation or high temperature. It is not recommended to use this method to sterilize dry powder products.
(2) Vapor phase sterilization method
Refers to the method of killing microorganisms by sterilizing agents distributed in the air.
Commonly used sterilants include hydrogen peroxide, peracetic acid, etc.
This method is suitable for sterilizing internal surfaces of confined spaces
(3) Liquid phase sterilization method
It refers to the method of completely immersing the items to be sterilized in the sterilizing agent to kill microorganisms on the surface of the items.
Sterilizers include formaldehyde, hydrogen peroxide, peracetic acid, sodium hydroxide, sodium hypochlorite, etc.
3. Aseptic operation method
Refers to the operating method that must produce sterile preparations under aseptic control conditions.
This method is suitable for the preparation of injections, ophthalmic preparations, sponges and wound preparations of some heat-labile drugs.
Products prepared according to aseptic methods are generally no longer sterilized.
(1) Sterilization of sterile operating room (filter sterilization method is used for circulating air)
1. Gaseous hydrogen peroxide sterilization method
2. Formaldehyde solution heating fumigation method
3. Ozone gas sterilization
4. Others (mainly used for countertops, equipment surfaces, etc. in sterile rooms)
0.1%～0.2% benzalkonium bromide solution
75% ethanol
2% coal phenol soap solution
1% povidone-iodine solution
(2) Aseptic operation (sterile operating room, laminar flow clean workbench, and aseptic operating cabinet are the main places for aseptic operation
All items, instruments and environments used in aseptic operations need to be sterilized
Operators should strictly follow the operating procedures for purification treatment
Materials are sent into the room under sterile conditions
Strictly separate the flow of people and materials