Construction requirements of injection GMP workshop? -common problem

Construction requirements of injection GMP pharmaceutical cleanroom?

The design of the injection GMP workshop should be based on the process flow to achieve air purification, personnel purification, material in and out purification, and equipment operation cleaning, including the separation of logistics and personnel, the distinction of production environment, the reasonable setting of auxiliary rooms, and the need for arrangement of production workshops. Heat, dehumidification, room...

Text label: GMP workshop construction requirements, injection GMP pharmaceutical cleanroom

Construction requirements for injection GMP workshop?

The design of the injection GMP workshop should be based on the process flow to achieve air purification, personnel purification, material in and out purification, and equipment operation cleaning, including the separation of logistics and personnel, the distinction of production environment, the reasonable setting of auxiliary rooms, and the need for arrangement of production workshops. Heat, dehumidification, tool cleaning and other functional settings in the room, and professional designs such as drainage, gas supply, strong and weak electricity, cooling and ventilation, and heating should be in line. The area with high cleanliness level should maintain a positive pressure difference of 5-10Pa compared with the area with low cleanliness level. If there are no special requirements for the process, the temperature of the clean area is generally 18-26℃, and the relative humidity is 45%-65%. Each process needs to be installed ultra violet light. The design of the workshop should implement the principle of separation of personnel and logistics. When personnel enter the production workshops of various levels, they must first change their clothes, and the production areas of different levels need to have corresponding levels of clothes-changing purification measures.

The production area should be arranged in strict accordance with the production process. The production areas of the same level are relatively concentrated. When the rooms with different cleanliness levels are connected to each other, a transfer window or buffer room should be set up to make the material transfer route as short and smooth as possible.

One line of the logistics route is the raw and auxiliary materials. The materials are subjected to external cleaning for concentrated and diluted formulations. The other line is the ampoules. After the external cleaning, the ampoules enter the washing, filling and sealing line for cleaning and drying. The two lines converge in the potting and sealing process. The potted ampoules undergo sterilization, leak detection, bottle wiping, foreign matter inspection, and finally outsource the entire production process. Different production operations in the GMP pharmaceutical cleanroom for small-volume injections can be effectively isolated and must not interfere with each other; the walls, floors and ceilings in the workshop are smooth and clean, free of cracks, shedding dust particles and shells, not easy to accumulate dust, and not to grow mold; small-volume injections Thin preparation, filtration, potting, drying and cooling of ampoules should be carried out in a 10,000-level environment, and concentrated preparation or diluted preparation using a closed system can be carried out in a 100,000-level environment. Non-terminally sterilized small-volume injections, filling Preparations that do not require sterilization and filtration before, filling and sealing of injections, and cooling after drying and sterilization of ampoules should be locally grade 100. Preparations that require sterilization and filtration before filling should be in a 10,000-level environment, and other clean areas should be 10. Ten thousand. The water, electricity and process pipelines of the clean workshop should be concealed; the 100-level GMP workshop and the aseptic preparation filling room should not be equipped with pools and floor drains; the unqualified, recycled or returned products should be stored separately; the production equipment should be adapted to the production requirements, which is convenient for production Operation, repair and maintenance; the transmission equipment used in the 10,000-level clean area should not pass through the lower clean-level area; the sterilizer should have automatic monitoring and recording devices, and the monitoring instruments should be regularly calibrated and have complete records. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and clean workshops.

The installation of pipelines should minimize the number of connections, and it is forbidden to use filter equipment containing asbestos; the water pipeline should be sealed, and the air vent should be installed with a hydrophobic sterilizing filter that does not shed fibers. The water pipeline can prevent retention and be easy to remove and wash; Changing rooms, toilets, and disinfection facilities shall not have adverse effects on the clean area; the storage conditions of raw materials, auxiliary materials and packaging materials shall not allow them to be damp, deteriorated, polluted or prone to errors; ampoules shall not be sealed by top melting, and must be sealed after ampoules are sealed. Appropriate methods should be used for leak detection; if the purified air in the clean area can be recycled, measures to effectively avoid contamination and cross-contamination should be adopted.

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