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Raw material purification workshop

Author: Shenzhen Zhongjing Global Purification Technology Co., Ltd.Time:2018-07-26 13:44:58Views:1679

Raw material purification workshop
  • Raw material purification workshop

Air conditioning system design for raw material purification workshop

The raw material purification workshop room parameters will affect the product and materials, including temperature, humidity and suspended particles, and microorganisms are also an important indicator for certain pharmaceutical intermediates; if the purification workshop requires a certain amount of air to maintain the room Cleanliness, then room air supply is also an important parameter; room pressure difference is also an important parameter, used to maintain the direction of airflow between the two spaces, to avoid the pollution of suspended particles, and sometimes can also use air locks to treat pollutants Sufficient isolation; some special process operations, such as the weighing and preparation of raw materials or intermediates, may cause cross-contamination of dust or gas, and may cause wind direction to the operator, which is necessary for the operator. Special protective overalls are provided, or workstations are set up so that there is no airflow between the product and the operator.

The final product must be dispensed in a one-way flow cabinet with a high efficiency filter. In such an operating cabinet, the air flow moves down the operator and the product, leaving the station and moving towards the back of the room. The cross-contamination is evaluated and a closed dispensing operation is employed to reduce the level of material protection. If room air is used to dry or cool exposed products, the room should be considered part of the production equipment and must be determined in the same way as other rooms with product exposure; use barriers or isolation devices such as glove boxes or Glove bags, etc., can reduce the environment exposed by the process and can greatly reduce the size and cost of the HVAC system. Zhongjing Global Purification can provide supporting services such as raw material purification workshop, GMP workshop consultation, planning, design, construction, decoration and transformation.

Room temperature is a key parameter for both open and closed operations. Most intermediates and API components, products, materials and processes can withstand large temperature orientations. However, as exposure times increase, temperature ranges may Reduced; if room temperature is a critical parameter, the room temperature monitoring, recording, and alarm system must be commissioned and verified. The temperature-controlled system must be commissioned and the location of the hot and cold points must be calibrated in the room. The relative humidity, dew point or absolute moisture content of the room can affect the intermediates or products exposed to the environment. These intermediates or products are sensitive to the humidity of the air. The relative humidity has a negligible effect on the aqueous product, but the liquid product is in a low humidity room. After a period of time, moisture is lost, and humidity-sensitive products exposed to the environment are usually required to have a humidity of 30%-50%, but for some products with special low humidity requirements, the humidity parameter of the room will be lower.

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