3: Set up a special weighing room. If it is not in the production clean area, can the weighing and sub packaging materials be delivered to the production clean area from the storage area?

 A: Weighed and sub packed materials can be transported from the storage area to the production clean area. The cleanliness level of the weighing room should be consistent with the cleanliness level of the production environment. After weighing, the materials should be stored in a closed container. The transfer method should be specified, and there should be a cleaning procedure for entering the clean area. The material packaging after weighing shall meet the production requirements. The outer packaging shall be able to effectively protect the materials from being affected and polluted during the transportation process. At the same time, the outer packaging shall not pollute or affect the production environment.

4: The injection workshop and weighing room that can be sterilized finally are equipped with dust hoods. Do they meet the requirements of GMP 2010?

A: The risk is high. The weighing room should use one-way flow. For example, the design of dedusting pipe with dust cover should consider adequate transmission speed to ensure that the dust is taken away without settling in the pipe; The required conveying speed shall be determined according to the density of dust. The density of different materials may be different, and the conveying speed will be different. The adjustment of conveying speed shall be considered.

Suzhou Pharma Machinery Co., Ltd. specializes in the production of purification equipment such as air shower, transfer window, negative pressure weighing cover and dust-free workshop purification engineering. It has been focusing on purification equipment and purification engineering for many years, with rich experience and high reputation. Welcome friends in need to consult and communicate

                 

                 

Suzhou Pharma Machinery Co.,Ltd.

2022/10/12

Mia