Question 5: is the solid preparation workshop under negative pressure?

▍ answer: it must be negative pressure. The 2010 GMP stipulates that the weighing of raw and auxiliary materials must be carried out in a specially designed weighing room or weighing room. There is a vertical downward airflow in the weighing room, and the inside must be negative pressure relative to the outside to prevent dust diffusion and cross pollution.

Question 6: is there a wind speed requirement in the weighing room of the solid preparation workshop?

▍ answer: the wind speed is 0.36-0.54m/s. According to the GMP standard, the wind speed must be within this range. Too low or too high wind speed is not conducive to dust removal.

Question 7: why is the weighing room in the solid preparation workshop negative pressure?

▍ answer: negative pressure is to prevent dust diffusion and cross pollution, and protect the safety of staff and the surrounding environment. Therefore, the weighing room in the solid preparation workshop must be negative pressure.

Question 8: what is the three prevention function of the negative pressure weighing room?

▍ answer: prevent cross contamination

Prevent dust from flying

Prevent dust from causing injury to workers.

Question 9: can the non purchasing negative pressure weighing room pass the new GMP certification?

▍ answer: No. According to Article 52 of the 2010 GMP, the weighing of raw and auxiliary materials must be carried out under the weighing equipment that meets the regulations.

Question 10: how clean is the weighing room?

▍ answer: the 2010 GMP clearly stipulates that the weighing room must be consistent with the environmental cleanliness of production and feeding, and protective measures must be taken to prevent cross contamination in the work area. Therefore, the cleanliness of the weighing room must reach grade A for sterile drugs and grade C or B for non sterile drugs.

                 

                 

Suzhou Pharma Machinery Co.,Ltd.

2022/08/01

Mia