1: Is it possible to directly discharge the dust out of the room with an exhaust fan when weighing materials? Or must we use a hundred level laminar flow?

A: Direct discharge is not allowed, but it is not necessary to have a hundred level laminar flow. There should be one-way flow in the weighing or batching room to protect products and operators. Generally, smoke test is used to confirm whether it is one-way flow. As for the level, it should at least be consistent with the requirements of the production environment. The air cleanliness level of the weighing room shall be consistent with the production requirements, and the specific level can be determined according to the products and processes produced by the enterprise. The design of using exhaust fan to directly discharge dust outdoors cannot ensure the cleanness of production environment and does not meet the requirements of safety and environment.

2: Whether the weighing room is set in the warehouse or in the production clean workshop, can the raw materials that have not been outsourced enter the production clean area?

A: The weighing room can be set up in the warehouse or clean area. Those who have not been outsourced but have been cleaned can enter the clean area for non sterile drug production. Generally, they should be outsourced. The air cleanliness level of the weighing room shall be consistent with the production requirements. The packaging entering the clean area shall be kept clean, and the packaging materials shall be free of chips, dust, odor, etc., and shall not affect the production environment, production process, and product quality.

                 

                 

Suzhou Pharma Machinery Co.,Ltd.

2022/09/26

Mia