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Nowadays, China's food processing, medical and health d […]
Nowadays, China's food processing, medical and health development, the workshop purification industry has also ushered in a new life. Especially after the release of the new GMP-2010 and the implementation of the medical structure reform, the demand for purification in the workshop industry and the medical field has been greatly promoted, making the workshop purification industry more promising.
Pharmaceutical purification workshop
GMP requires that the chemical plant workshop should have good production equipment, reasonable production process, perfect quality management and strict inspection system to ensure that the final product quality (including food safety and hygiene) meets the requirements of the regulations.
1. Minimize the floor area
Workshops with clean grade requirements not only have a large investment, but also have high recurring costs such as water, electricity and gas. In general, the higher the cleanliness level of the plant, the greater the investment, energy consumption and cost. Therefore, under the premise of meeting the production process requirements, the building area of the clean plant should be minimized.
2. Strictly control the flow of people
Dedicated human flow and logistics channels should be set up in the purification of pharmaceutical workshops. Personnel should enter the system according to the prescribed purification procedures and should strictly control the number of people. In addition to the standardized management of personnel entering and leaving the purification of the pharmaceutical factory, the raw materials and equipment must also go through the clean-up procedure, so as not to affect the cleanliness of the clean room.
3. Reasonable arrangement
(1) Clean room equipment should be arranged as compact as possible to reduce the area of the clean room.
(2) There is no window or window between the clean room and the clean room to close the outer corridor.
(3) The door of the clean room is required to be sealed, and the air lock is installed at the entrance and exit of the person and the object.
(4) The clean room of the same level should be arranged as much as possible.
(5) The clean rooms of different levels are arranged from low to high. The rooms connected to each other should be equipped with partition doors. The corresponding pressure difference is designed according to the cleanliness level. Generally, the opening direction of the door is about lOPa, and the opening direction of the door is toward the room with high cleanliness level.
(6) The clean room should be kept at a positive pressure. The space of the clean room is connected in order of the level of the clean and clean, and there is a corresponding pressure difference to prevent the air in the low-level clean room from flowing back to the advanced clean room. The net pressure difference between adjacent rooms with different air cleanliness levels should be greater than SPa. The net pressure difference between clean room (zone) and outdoor atmosphere should be greater than lOPa, and the door opening direction should be toward the room with high cleanliness level.
(7) Ultraviolet light in the sterile area, generally installed on the upper side of the sterile working area or at the population.
4. The pipeline is as dark as possible
In order to meet the requirements of the purification level of the workshop, various pipelines should be darkened as much as possible. The outer surface of the Ming-laying pipeline should be smooth, and the horizontal pipeline should be equipped with technical interlayer or technical clamping. The vertical pipeline passing through the floor should be equipped with technical shaft.
5. Interior decoration should be conducive to cleaning
The walls, floors and top floors of the clean room should be smooth, crack-free, and not accumulating static electricity. The interface should be tight, free of particulate matter, and can withstand cleaning and disinfection. The junction between the wall and the ground, walls and walls, walls and ceilings should be curved or other measures should be taken to reduce the accumulation of dust and facilitate cleaning.