Production of sterile preparations in GMP workshop
The production process of aseptic preparations in the GMP pharmaceutical cleanroom is generally divided into sterilization process and aseptic production process. Aseptic products usually require product filling and container sealing in a strict production environment. Combined with the subsequent sterilization process of the final product to ensure Sterility level; aseptic production process, capacity...
Text label: GM workshop design, GMP pharmaceutical cleanroom installation, sterile preparation production
GMP pharmaceutical cleanroom aseptic preparation production
The production process of sterile preparations in GMP workshops is generally divided into sterilization process and aseptic production process. Aseptic products usually require product filling and container sealing in a strict production environment, combined with subsequent sterilization of the final product. The sterilization process ensures the level of sterility; the aseptic production process, containers and sealing components are first sterilized and depyrogenated in an appropriate manner, respectively, and then filled and sealed under the protection of laminar flow, which requires strict control relative to the terminal sterilization process Sterility of each process step. Commonly used sterile preparations include water injection and powder injection. General production equipment includes preparation tanks, sterile filtration, sterilization equipment, washing and drying tanks, cleaning equipment, and isolator equipment. For freeze-dried preparations, it also includes freeze dryers. , bottle washing, drying, filling equipment, usually linked operation.
The preparation of the solution is to prepare the active ingredients, auxiliary materials and dissolved ingredients according to the requirements of the process regulations, and mix them in order to prepare a batch preparation solution for the next filling; the preparation can include the dissolution of the active ingredients , or a simple liquid mix. The packaging containers used for sterile preparations mainly include vials, ampoules, etc. The equipment for cleaning these containers is a bottle washer, including a bottle loading unit, a bottle unscrambler unit, an ultrasonic cleaning unit, a purging unit, and a bottle discharging unit. The cleaning steps are divided into pre-washing, purified water cleaning and water-for-injection cleaning; the cleaned container enters the tunnel depyrogenation oven for drying and depyrogenation under the protection of laminar flow, and the tunnel oven can use unidirectional flow or heat radiation device , no matter which method is used, it is generally divided into a preheating section, a high temperature sterilization section and a cooling section. In the tunnel sterilization section, the container combines the set temperature and residence time to achieve the required sterilization and depyrogenation effect. After cooling down to a temperature that does not affect the quality of the filling product, it enters the filling and sealing machine under the protection of laminar flow. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and sterile workshops.
Physical sterilization is to take advantage of the unstable properties of proteins and nucleic acids when exposed to heat and radiation, and to remove microorganisms by heating, radiation and filtration, including dry heat sterilization, moist heat sterilization, sterilization filtration and radiation Sterilization method, etc., no matter what sterilization method, the sterility assurance level generally requires that the level of sterilization should reach 10-6, that is, the content of 106-level live bacteria should not survive more than one after sterilization. The key to the filtration sterilization method is the filter, which is generally used for the filtration and sterilization of liquid materials. In addition to ensuring the sterility guarantee level of 10-6, the sterilization filter also needs to ensure the safety of the preparation materials, and the Material-liquid compatibility, bacterial retention efficiency, structural integrity before and after use, etc. Dry heat sterilization is the use of electric heaters to kill microorganisms in a sterilizer. It is generally used for the sterilization of high-temperature items, such as glass, metal equipment, appliances and other items that do not require moisture penetration. It is not suitable for the sterilization of rubber, plastics, etc., usually the sterilization temperature is higher than 160 ℃, and it can be used to remove pyrogens higher than 250 ℃.
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