Application of air cleaning technology in GMP workshop
Application of air cleaning technology in GMP workshop
In addition to meeting the purification requirements and temperature and humidity requirements of the workshop, the air-conditioning system of the tablet production workshop of the GMP workshop is important to effectively control the dust in the production area to prevent cross-contamination of dust through the air system; Layout, process equipment selection, workshop...
Text label: GMP workshop design and decoration, GMP pharmaceutical cleanroom clean technology, GMP workshop clean company
Application of air cleaning technology in GMP workshop
In addition to meeting the purification requirements and temperature and humidity requirements of the workshop, the air-conditioning system of the tablet production workshop of the GMP workshop is important to effectively control the dust in the production area to prevent cross-contamination of dust through the air system; In addition to taking a series of measures in layout, process equipment selection, workshop, operation and management, isolation hoods and dust removal equipment are set up at dust-producing points and dust-producing areas; indoor pressure is controlled, and dust-producing rooms should maintain relatively negative pressure; For tablet workshops that produce batches of varieties, the rooms that generate dust do not use circulating air, and the dust control devices can be submerged flow dust collectors, environmental control rooms, counter laminar flow weighing workbenches, etc.
The production of water injection is divided into terminal sterilization products and non-terminal sterilization products. The main production processes have different requirements for cleanliness. The former's potting and bottle processing requirements are C-level or local A-level under the background of C-level , the latter is local grade A under the background of B grade; large-volume injections and small-volume injections have different grade requirements, and the filtration and potting of terminally sterilized large-volume injections also need to be in the local A-level environment under the C-level background. , and due to the wide application of blowing and sealing systems, the exposure time under the open condition of the drug is shortened, so the final sterilization of small-volume injections can be filled and sealed under C-level conditions; the purification system can use water needle washing, tank, Seal the air purification device of the motor or choose a U-shaped water needle assembly line. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and sterile workshops.
The final product produced by powder injection is not subject to sterilization treatment. The main process needs to be in a high-level clean room. The exposure environment of powder injection, sub-packaging, plugging, capping, and final treatment of sterile inner packaging materials is a B-level background. The lower part is Class A; the minimum environmental cleanliness requirements for weighing, bottle washing, and sterile clothing preparation processes are Class D; the air cleanliness for liquid dispensing, sterile changing rooms, and sterile buffer corridors is Class C; The cleanliness level of the press stopper and sterilization bottle storage is local level A under the background of B level. The temperature of the main production process is 20-22°C, and the relative humidity is 45%-50%. In the powder injection line, a sterilization tunnel can be used. , the air purification device of the filling machine and the capping machine, and the laminar flow belt technology can also be applied to the powder needle production.
The air conditioning and purification design conditions that the process designer must provide to the air-conditioning professional designers include: process equipment layout plan, and indicate the purification area; the area and volume of the purification area; the form of purification; the number of indoor air changes; cleanliness requirements and level; temperature, humidity, pressure difference inside and outside the production workshop; production varieties.
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