In vitro diagnostic reagent workshop project
In vitro diagnostic reagent workshop project
The plant design of the in vitro diagnostic reagent workshop includes: space design; human flow and logistics design; appropriate isolation design; use of suitable building decoration materials, etc.; A good environment, away from serious air pollution...
Text label: diagnostic reagent workshop project, in vitro diagnostic reagent workshop project, purification workshop project
In vitro diagnostic reagent workshop project
The plant design of the in vitro diagnostic reagent workshop includes: space design; human flow and logistics design; appropriate isolation design; use of suitable building decoration materials, etc.; A good environment, away from areas with severe air pollution, water pollution, vibration or noise disturbance. The process layout of the workshop should meet the requirements of the production process and air cleanliness level, and should be comprehensively determined according to the requirements of various technical measures such as process equipment installation and maintenance, pipeline layout, airflow pattern, and purification of air conditioning systems. The height should be designed according to the process requirements; the raw and auxiliary materials, semi-finished products, finished product storage areas and quality control laboratories that are suitable for the production scale should be set up near the production area.
The air-conditioning purification system is equipped with temperature, humidity control and air purification and filtration; the materials of storage tanks, conveying pipes and pipe fittings should be non-toxic, corrosion-resistant and easy to sterilize; the branch pipes introduced into the clean room should be hidden and the process pipes should be installed. It is not advisable to pass through the clean area unrelated to it; small concealed electrical boxes and socket boxes, and equipment with higher power should be directly powered by the power distribution room. In the design and layout of the factory building of in vitro diagnostic reagents, four areas are generally considered, namely the production area, the quality control area, the storage area and the auxiliary area. Production area: It includes clean production area and non-clean production area. The design of clean production area should be reasonably arranged according to the production process and the required air cleanliness level. The flow of people and logistics should be reasonable; the non-clean production area is generally used for products. packaging, label printing and other operations. Auxiliary area: including restrooms, toilets, changing rooms, etc. The setting of the restrooms should not cause adverse effects on the production area, storage area and quality control area; the changing rooms and toilets should be convenient for personnel to enter and exit, and should be suitable for the number of users ; The toilet is not directly connected to the production area and the storage area. Storage area: There should be enough space to ensure orderly storage of materials, intermediate products, products to be packaged and finished products; receiving, issuing and shipping areas should be able to protect materials and products from the environment. Quality control area, usually separate from production area; pharma machinery design should ensure that it is suitable for its intended use and to avoid mix-ups and cross-contamination; there should be adequate areas for sample handling, sample retention and record keeping. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for in vitro diagnostic reagent workshops, diagnostic reagent GMP workshops, and medical device workshops.
The inner surface of the diagnostic reagent pharmaceutical cleanroom should be smooth and flat, without cracks, tight joints, no particles falling off, avoid dust accumulation, and facilitate cleaning. The ground should be flat, wear-resistant, non-dusting, resistant to acid and alkali erosion; and the material should be non-polluting, not easy to accumulate static electricity, avoid glare, not crack, and the ground should be processed without seams; the cushion in wet areas should have a moisture-proof structure. Doors and windows should be double-glazed fixed windows, with good air tightness, and wooden materials should not be used; they should be flush with the inner wall, and window sills should not be installed on the side of the clean room; indoor airtight doors should be in the direction of high air cleanliness Open, and add a door closer; the gap should take reliable sealing measures. Lamps should be installed on the surface and should not be suspended; pools and floor drains in the clean room area should be equipped with devices to prevent backfilling; floor drains should not be installed in the 100-level clean room area; clean production environments mainly rely on air purification systems, electrical safety facilities, disinfection and sanitation Facilities, ventilation and dust removal facilities, etc. work together to reduce and remove pollution.
Product production environment requirements in the in vitro diagnostic reagent workshop: the pressure difference should not be less than 10Pa; the preparation, sub-packaging, drying and inner packaging of the reagents should be carried out in a D (100,000) clean environment, and positive serum, antigen The aliquots with antibodies should be in a C (10,000) class clean environment. Requirements for sampling environment: a special sampling room for materials should be set up, and the cleanliness level of the sampling room should not be lower than the cleanliness level when the materials are used; material sampling should be carried out as far as possible in the special sampling room or in the production environment where the materials are used. , each material should be cleaned after sampling. Requirements for the microbiological testing room: the microbiological testing room includes a sterile inspection room, a microbial limit room, a positive control room, etc.; the environmental cleanliness conditions of the sterile testing room should not be lower than the sterile production operation area; the microbial limit room should not be lower than A Class B unidirectional air area against a Class D background.
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