Purification measures for tablet production in GMP workshop
Purification measures for tablet production in GMP pharmaceutical cleanroom
The process of tablet production in the GMP workshop generally includes: intermediate station, batching, granulation, drying, sieving, tableting, coating, packaging, field clearance, etc. The intermediate station is unique to tablet production, and the intermediate station and the The production environment is at the same level and should have enough area, pay attention to here also...
Text label: GMP workshop design and installation, GMP workshop purification, tablet production purification measures
Purification measures for tablet production in GMP pharmaceutical cleanroom
The process of tablet production in the GMP workshop generally includes: intermediate station, batching, granulation, drying, sieving, tableting, coating, packaging, field clearance, etc. The intermediate station is unique to tablet production, and the intermediate station and the The production environment should be of the same level and should have enough area. Pay attention to the problem of dust emission here; when using fluidized bed drying, pay attention to the cross-contamination of the exhaust gas, and the exhaust gas should be filtered by dust removal; the tableting should pay attention to the problem of particle diffusion and dust removal , local relative negative pressure should be maintained; coating should pay attention to local relative negative pressure, there is a problem of dust removal and dust removal; packaging should pay attention to the packaging machine should have a dust extraction device;
In order to prevent the dust from flying and spreading, it is best to isolate the dust source with a physical barrier. It should not wait until the dust has spread to the whole room before ventilating and diluting; For example, the shape of the dust source equipment is special, the dust exhaust and suction hood cannot be installed, and physical isolation can only be carried out in a large range; the isolation methods include on-site isolation, one-side isolation, and independent isolation; the isolated production process has a significant impact on the air cleanliness. It is quite required. In this case, clean air can be sent to the isolation area to achieve a certain level of cleanliness. A buffer room is set at the entrance of the isolation area. The buffer room and the isolation area maintain the same cleanliness level so that the pressure is higher than that of the isolation area and the isolation area. outside. The isolation area requires a large amount of air. In this case, if this part of the exhaust air comes from the outside workshop, it will increase the cooling and heating load and purification load of the large system. The exhaust air in the isolation area can be filtered and then sent back to the isolation area. The isolation area forms a self-circulation, but in order to make the isolation area slightly negative pressure, a bypass branch pipe is opened on the return air pipe section after dust removal and filtration to discharge to the outdoor or workshop. The isolated production process does not require high air cleanliness. In this case, an independent exhaust can be set up in the isolation area, so that the air in the workshop outside the isolation area can enter the isolation area through the air outlet on the physical barrier. If the exhaust air volume is not large There is no need for openings, and the wind can be entered through the gaps or louvers of the barrier. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and clean rooms.
The dust collector is installed in the mechanical room close to the production workshop. This method can reduce the impact of noise and avoid secondary pollution to the workshop due to improper dust removal. The single-machine dust collector and process equipment can be placed in the same room, and the exhaust gas can be directly It is a common method to discharge into the room. Although this method is simple and easy to implement, due to the low efficiency of the dust collector, the air discharged into the production workshop contains a high concentration of dust particles, so if the outlet is not equipped with a sub- Not suitable for use with HEPA or HEPA filters. When using physical isolation, under normal circumstances, there is no need for someone to operate in the isolation area. The isolation screen has a door, which can be checked regularly. The isolation area needs to discharge dust-laden air, and its interior is negative pressure. For solid preparation workshops that change batches of multiple varieties, in order to prevent cross-contamination, fresh air should be used instead of circulating air. Under this principle, the amount of fresh air should be reduced as much as possible.
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We should take a step back to review how PHARMA approach tracking, implementing, and communicating compliance-related changes and attempt to identify areas of improvement in their processes.