Sterilization Methods Commonly Used for Pharmaceuticals in GMP Workshops
2024.12.06
In the pharmaceutical field, quality and safety are like the Sword of Damocles hanging over our heads, leaving no room for any slack. As pharmaceuticals are special commodities that directly act on the human body and are closely related to life and health, their production processes must strictly adhere to the GMP (Good Manufacturing Practice) standards, and the sterilization process is of paramount importance. As Guangzhou Cleanroom Construction Co., Ltd., which has been deeply involved in the construction of purification equipment and workshops for a long time, today we will take you to explore the commonly used pharmaceutical sterilization methods in GMP workshops.
Moist Heat Sterilization: The "Sterilization Guardian" Under High Temperature and High Pressure
Moist heat sterilization can be regarded as the "leading method" among the sterilization means in GMP workshops. It is widely applied and has outstanding effects. It utilizes high-temperature saturated steam to quickly penetrate pharmaceutical packaging and materials under high-pressure conditions, directly hitting the core of microorganisms. For pharmaceutical materials with extremely high aseptic requirements, such as large-volume injections and culture media, when placed in a sterilization cabinet and treated at a high temperature of 121 °C or 134 °C under corresponding pressures for a certain period of time, the proteins in bacteria, spores and other microorganisms will be coagulated, denatured due to heat, and their nucleic acids will be damaged, immediately terminating their life activities. The sterilization rate can steadily reach above 99.99%.
The advantages are obvious. Steam is cheap and easy to obtain, and the sterilization process can kill bacteria comprehensively and efficiently. However, there are also quite a few challenges. Precise control of temperature, pressure and time is a technical task. Any slight mistake will affect the quality of pharmaceuticals. Moreover, the equipment maintenance cost is relatively high, and it is necessary to regularly check the seals and pipelines to ensure the stable output of steam.
Dry Heat Sterilization: The "Sterilization Pioneer" in Intense High Temperature
Dry heat sterilization mainly focuses on "high-temperature burning". It heats the air to a temperature far exceeding the boiling point of water by using electric heating or infrared heating, usually ranging from 160 °C to 180 °C or even higher, and maintains it for a specific period of time. Glassware, metal instruments, high-temperature-resistant powder raw materials and so on are often sterilized by this method. During the production of aseptic powder injections, the vials used for filling are dried at a high temperature in a dry heat tunnel oven. While removing moisture, the surface microorganisms are killed, making the vials sterile and dry, meeting the requirements for pharmaceutical filling.
Compared with moist heat sterilization, the penetration ability of dry heat sterilization is weaker. However, the sterilized items are dry after sterilization, and the absence of moisture residue is beneficial to the subsequent pharmaceutical processing. The disadvantages are that it takes a long time, consumes a large amount of energy, the equipment heats up and cools down slowly, and it has high requirements for the stable power supply in the workshop. Improper operation may also cause items to be burned or deformed.
Radiation Sterilization: The "Sterilization Surprise Troop" in Invisible Rays
When the light of science and technology meets pharmaceutical sterilization, radiation sterilization emerges as the times require. Commonly used gamma rays and electron beam rays are like "cleaning agents" in the microscopic world. They have high energy and extremely strong penetration ability, and can act on the inside of pharmaceutical packaging remotely. For heat-sensitive and composition-sensitive pharmaceuticals such as disposable medical consumables and Chinese herbal medicine extracts, under the irradiation of gamma rays from the cobalt-60 radiation source, the double strands of microbial DNA are broken, and their reproduction and metabolic functions are paralyzed, easily achieving sterility.
The advantages are prominent. It is a low-temperature sterilization method that does not damage the active ingredients, physical and chemical properties of pharmaceuticals. It can handle batches of products efficiently. However, the hidden danger lies in the strict control of radiation sources. The upfront investment in equipment is large, and professional protective facilities are required to prevent radiation leakage. Operators need to receive special training and take full protective measures throughout the process.
Gas Sterilization: The "Disinfection Expert" in Gaseous Mist
Gas sterilization relies on chemical gases to permeate the interior of workshops and equipment to "encircle and suppress" microorganisms. Ethylene oxide is a commonly used "sharp tool". With its extremely strong penetrability, it can penetrate into the gaps of packaging and porous materials, react with the proteins and nucleic acids of microorganisms, and "kill" bacteria, fungi and viruses. When disinfecting and sterilizing some structurally complex medical devices and packaged pharmaceutical products, they are placed in an ethylene oxide sterilization cabinet, and the parameters such as concentration, temperature, humidity and time are set to complete the disinfection.
The effect is remarkable. However, ethylene oxide is flammable, explosive and toxic. The ventilation and exhaust gas treatment systems in the workshop must be meticulous and comprehensive. If the residual gas exceeds the standard, it will endanger human health and pollute the environment. Therefore, the subsequent desorption process is essential to ensure that there is no residue in pharmaceuticals.
Filtration Sterilization: The "Impurity Interceptor" in Front of the Microscopic Filter Screen
Filtration sterilization is like setting up precise "checkpoints" along the path through which pharmaceuticals flow. Using sterilization filters with extremely small pore sizes (mostly 0.22 microns or 0.45 microns), it physically intercepts planktonic bacteria in the air and bacteria carried by dust. In the ventilation systems of aseptic pharmaceutical production workshops and the air inlets of liquid medicine filling machines, filters play a role of "checking" layer by layer to ensure that the air entering the pharmaceutical production process is pure and sterile.
The advantage is that the whole process is gentle and does not affect the ingredients and properties of pharmaceuticals. The equipment is simple and the operation cost is low. However, the filters need to be replaced regularly and their integrity should be inspected. Once damaged, bacteria will take advantage of the opportunity and all previous efforts will be wasted.
Pharmaceutical sterilization is no trifling matter. Each method has its own advantages, disadvantages and applicable scenarios. Guangzhou Cleanroom Construction Co., Ltd. is familiar with the ins and outs of GMP workshops and can customize sterilization schemes according to the characteristics and production scales of pharmaceuticals, and match suitable purification equipment to comprehensively safeguard the sterile quality of pharmaceuticals. If you encounter difficulties in pharmaceutical sterilization, workshop construction or operation, please feel free to consult us. Let's build a defense line for pharmaceutical safety together.
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