Layout design of preparation workshop
Layout design of preparation pharmaceutical cleanroom
The preparation workshop should be rationally arranged according to the technological process. Reasonable and compact is conducive to the production operation, and can ensure the effective management of the production process; Cross-contamination of intermediates and semi-finished products...
Text label: preparation workshop, preparation purification plant, preparation workshop design, preparation plant decoration
Plant layout design of preparation workshop
The preparation workshop should be rationally arranged according to the technological process. Reasonable and compact is conducive to the production operation, and can ensure the effective management of the production process; For cross-contamination and mixing of intermediates and semi-finished products, coordination of personnel and logistics, coordination of technological processes, and coordination of cleanliness levels should be achieved; the workshop should be equipped with corresponding intermediate storage areas and auxiliary rooms; The space, construction structure and decoration should be conducive to cleaning and maintenance; the workshop should have good lighting and ventilation, and local ventilation can be added according to process requirements.
The workshop should be designed according to the requirements of general production areas and clean areas. In order to ensure the air cleanliness requirements, unnecessary personnel and logistics flow should be avoided; the layout of workshops, equipment, pipelines and equipment installation should be based on the prevention of product contamination It is easy to clean; the workshop can be dust-proof, insect-proof, rodent-proof, etc. pollution; the workshop should be equipped with replacement varieties and daily cleaning equipment, pipelines, containers and other necessary pools, sewage and other facilities. The setting of these facilities cannot affect Requirements for cleanliness in the workshop; in order to meet the hygienic requirements of products, the workshop should be partitioned. The principle is to prevent the mixing and contamination of products, raw materials, semi-finished products and packaging materials, and leave enough area for operation. Locations that must be separated: between the general production area and the clean area; between the passage and each production area; raw material warehouse, packaging material warehouse, finished product warehouse, etc.; raw material weighing room; each process and packaging room, etc.; equipment cleaning places. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for preparation clean workshops and preparation purification plants.
The preparation workshop is reasonably arranged and partitioned according to the technological process and quality requirements. According to the specifications, the preparation workshop can be divided into two areas, namely the general production area and the clean area (Class D, Class C, Class B, Class A). Class D: the production process of oral solid preparations except for bottle washing and outer packaging; the whole process of capsule shell production; oral liquid preparations filling, potting, capping; final sterilization product liquid preparation and filtration, rolling Caps, product preparation and filtration, final cleaning of packaging materials and utensils in direct contact; rough washing in the bottle washing section and refining, drying, and inner packaging of waste sterile APIs, etc. Class C: fine washing, drying, and storage sections for final sterilized injections; preparation room, rough filtration, and bottle cleaning for injections that cannot be autoclaved; dilution, rough filtration, filling, bottles, caps, Fine washing of film, adding film and capping; filling of eye drops; sterilization of outer packaging of sterile powder injection and lyophilized raw materials, bottle washing, fine washing of rubber stopper, and capping.
Class B: drying and storage of injection bottles that cannot be autoclaved in the end; sterile filtration, sub-packaging and capping of freeze-dried preparations; fine filtration, filling, sealing and cooling of glass bottles for injections; Infusion fine filtration, filling, capping, bottle stopper, membrane cleaning; powder injection raw material inspection, glass bottle cooling, raw material allocation, sieving, powder mixing, sub-packaging, and capping; filtration, Crystallization, separation, drying, sieving, powder mixing, packaging; coarse and fine separation of plasma products. Local Class A: Sterility inspection; strain inoculation workbench; fine filtration, filling, membrane release, and capping of infusion; assembly of membrane filters for aseptic production; sterile filtration and filling of freeze-dried preparations; no The glass bottle for bacterial powder injection is cooled, subpackaged and capped; the freeze-drying room of blood products, the coarse separation workbench and the fine separation workbench of plasma. The clean partition is formulated according to the GMP regulations. As raising the standard will increase energy consumption and cost, the standard should be formulated according to the actual needs, and there is no need to raise the standard without limit.
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