GMP clean workshop packaging material handling
GMP clean pharmaceutical cleanroom packaging material handling
Materials used in the production of GMP clean workshops, raw and auxiliary materials, vials, aluminum caps, rubber stoppers, finished packaging cartons, product labels, etc., are first sent to the unpacking room in the clean area of u200bu200beach user position, and the outer packaging of the materials is removed. After packaging, it is sent to the post for use; in the freeze-drying production...
Text label: GMP clean pharmaceutical cleanroom, GMP pharmaceutical cleanroom packaging processing, GMP clean workshop design and installation
GMP clean workshop packaging material handling
Materials used in the production of GMP clean workshops, raw and auxiliary materials, vials, aluminum caps, rubber stoppers, finished packaging cartons, product labels, etc., are first sent to the unpacking room in the clean area of u200bu200beach user position, and the outer packaging of the materials is removed. After packaging, it is sent to the post for use; the glassware that needs to be used in the freeze-drying production process should undergo a series of cleaning treatments before sterilization, usually repeated washing and rinsing. The cleaning process can effectively remove the adhesion on the surface of the container All kinds of dirt and impurities; in general, purified water is used to rinse the surface of the vessel to avoid contamination of the container, and the final rinse should meet the requirements for water for injection; the vial is rinsed with bottle washing, distilled water and sterile air, and sent to Enter the tunnel type dry heat sterilizer for continuous dry heat sterilization by unidirectional high-temperature airflow heating or far-infrared heating. , should be protected by 100-level one-way flow clean air, and automatically sent to the filling room after drying and sterilization.
The washing effect of the glass bottle, the cleanliness of the bottle after washing, whether it is recontaminated before use after sterilization, these quality control contents are mainly completed by checking the cleanliness of the washing water and the bottle, and if necessary, the pollution during the washing process Challenge trials to control. The main principle of rubber stopper treatment is to use pure, pyrogen-free water for injection to wash and remove the impurity particles on the surface of the rubber stopper, and to dilute the pyrogen substances on the surface of the rubber stopper to below the detection sensitivity; As the cleaning process continues, the surface of the rubber stopper is continuously damaged by friction. The longer the cleaning time, the more serious the mechanical damage to the surface of the rubber stopper. The cleaning method of the rubber stopper determines the rubber stopper surface. For the speed and degree of damage to the plug, a non-damaged rubber stopper cleaning method should be selected; the rubber stopper should be removed from the outer packaging in the material storage room in the clean area, and then moved to the rubber stopper processing room after counting the number, and the rubber stopper should be cleaned with purified water. After the inner packaging, put it into the washing machine, rinse, siliconize, rinse, and then sterilize and dry. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP clean workshops and dust-free workshops.
In most freeze-drying processes, the rubber stopper treatment process includes a siliconization process. Siliconizing the rubber stopper is beneficial to reduce the adhesion of the rubber stopper during sterilization and the transfer of the rubber stopper during filling. Pay attention to improper siliconization. At the same time, the silicone oil used in the preparation of the rubber stopper should meet the appropriate quality control standards; the container sealing system of the lyophilized sterile drug product should be able to prevent the intrusion of microorganisms, and any damage should be detected during the inspection of the final sealed product. or defective products, and reject them. Strict safety measures should be taken to prevent products with defective container sealing that can lead to contamination from being put on the market; poor equipment adaptability and defective supply of containers and sealing parts can all lead to container sealing systems. If some defects that cause product sealing problems are difficult to find, you should try to take improvement measures as soon as possible to prevent the production and detection of defective products. The final rinse medium of the inner packaging container must be water for injection. Purified water can only be used in the initial cleaning stage of the inner packaging container. Purified water for washing can be recovered by pre-filtering the water and using a membrane filter with a special pore size. use. After cleaning the rubber stopper, it should be sterilized and dried. The sterilization at this time is usually wet heat sterilization. These steps can be completed individually or in combination and continuously, preferably at the same time. The filter is sterilized and dried in the filter air protection.
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