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1, turbulent flow The air enters the GMP purification w […]
1, turbulent flow
The air enters the GMP purification workshop from the air-conditioning box through the air duct and the air filter in the clean room, and returns to the wind by the partition wall panel or the raised floor on both sides of the GMP purification workshop. The airflow moves in a non-linear motion and is in an irregular turbulent or eddy current state. This type is suitable for GMP purification workshop grades of 1,000-100,000.
Advantages: simple structure, low system construction cost, and easy expansion of the clean room. In some special-purpose places, the dust-free workbench can be used together to improve the clean room level.
Disadvantages: The dust particles caused by turbulent flow are difficult to discharge in the indoor space, which is easy to contaminate the process products. In addition, if the system is stopped and then activated, it will take a long time to reach the cleanliness of the demand.
2, laminar flow
The laminar air flow moves into a uniform straight line, and the air enters the room from a filter with a coverage of 100% and is returned by the raised floor or the partition plates on both sides. This type is suitable for the environment where the GMP purification workshop level needs to be set higher. Generally, the clean room grade is Class 1~100. Its type can be divided into two types:
(1) Horizontal laminar flow type: The horizontal air is blown out from the filter in one direction, and the return air system of the opposite wall returns to the wind. The dust is discharged to the GMP purification workshop with the wind direction, and the pollution on the downstream side is generally serious.
Advantages: The structure is simple and can be stabilized in a short time after operation.
Disadvantages: The construction cost is higher than the turbulent flow, and the indoor space is not easy to expand.
(2) Vertical laminar flow: The ceiling of the GMP purification workshop room is completely covered by ULPA filter. The air is blown from top to bottom, which can obtain higher cleanliness. The dust generated by the workers during the process or the workers can be quickly discharged outside. Does not affect other work areas.
Advantages: Easy management, stable operation in a short period of time, and difficult to be affected by the operation status or the operator.
Disadvantages: the construction cost is high, the flexible use space is difficult, the ceiling hangers occupy a considerable space, and it is more troublesome to repair and replace the filter.
The composite type combines turbulent flow and laminar flow to provide partial ultra-clean air.
(1) Clean tunnel: 100% coverage of the process area or work area with HEPA or ULPA filter to improve the cleanliness level of GMP purification workshop to level 10 or above, which can save installation and operation costs. This type of work needs to isolate the operator's work area from product and machine maintenance to avoid work and quality when the machine is repaired. Most of the ULSI processes use this type. The clean tunnel has two other advantages: A. Elastic expansion is easy; B. It can be easily performed in the maintenance area when repairing equipment.
(2) Clean pipeline: Surround and purify the automatic production line through which the product flow passes, and raise the cleanliness level of the GMP purification workshop to above 100. Because the product and the operator and the dusting environment are isolated from each other, a small amount of air can be used to obtain good cleanliness, which can save energy, and no manual automated production line is most suitable for use. It is applicable to the pharmaceutical, food industry and semiconductor industries.
(3) Consolidate the local clean room: Increase the cleanliness level of the product processing area of the GMP purification workshop level 10,000~100,000 in the clean room to 10~1000 grade, for production purposes; clean workbench, clean room Clean work sheds and clean air cabinets belong to this category.
The purpose of the GMP purification workshop for biopharmaceutical companies is to ensure the establishment of a scientific and rigorous sterile pharmaceutical production environment, process, operation and management system to minimize all possible and potential biological activities, dust and pyrogen pollution. Produce high quality, hygienic and safe pharmaceutical products. The GMP purification workshop technology that we refer to as a biopharmaceutical company is one of the main means to ensure the successful implementation of GMP.