Question 11: is there any relationship between the calculated air volume of the negative pressure weighing room and the internal volume of the air outlet?

▍ answer: the design air volume of the weighing room is proportional to the air outlet area. The larger the area, the larger the air volume required; And vice versa.

Question 12: who provided the 3Q document of the negative pressure weighing room?

▍ answer: the 3Q document refers to the equipment IQ, PQ and OQ documents required for the new GMP certification. It is a necessary document for GMP verification. Generally, this document is prepared by the pharmaceutical factory itself. The manufacturer can provide or guide the pharmaceutical factory customers to prepare this series of documents to ensure the successful certification.

Question 13: what factors should be paid attention to when purchasing a negative pressure weighing room?

▍ answer: the size of the weighing room, the number of operators, the number of weighed drugs and other factors need to be considered when purchasing the weighing room.

Question 14: how to deal with the dust generated by weighing raw and auxiliary materials in the weighing room?

▍ answer: the weighing room is a vertical unidirectional air flow, so the dust will fall with the air flow and finally be adsorbed on the primary and medium efficiency filters at the bottom of the equipment.

Question 15: will the weighing room affect the airflow of the original room?

▍ answer: generally not. Because 85% - 90% of the air flow in the weighing chamber is internal circulation, it has little dependence on the external air flow compensation, so it has little impact on the outside. If there is a slight impact, it can be solved through fine adjustment of the room air regulating valve.

Suzhou Pharma Machinery Co.,Ltd.

2022/08/10

Mia