Powder injection workshop to accept the provincial bureau flight inspection
Release time:
2020-08-14
Powder Injection Workshop Accepted Flight Inspection by Provincial Bureau
News 10# July 25 , Zhejiang Drug Certification and Inspection Center appointed an inspection team to conduct flight inspection on the simulated filling test of culture medium in Powder Injection Workshop of Pharmaceutical Company. The
inspection team dynamically inspected the equipment assembly, lactose sub-packaging, medium filling, nitrogen filling (replaced by compressed air), plug pressing, capping and other operations of medium simulation filling on site. At the same time, the powder injection workshop batch production records, clean area disinfection records, simulation filling records, and the whole process of the simulation filling were observed. Check and seal the filled samples simultaneously. After all the lactose is dissolved and the filling output is counted, all the filling products are moved into the culture room for culture, and 5 continuous temperature monitors are placed in different parts of the culture room. During the culture period, the culture room is locked and sealed by the inspection team members and signed by the seam. After 14 days of culture (20-25 ℃ culture 7 days, 30-35 ℃ culture 7 days), the inspection team personnel shall open the seal and check the culture samples for infected bacteria and visible foreign bodies one by one. At the same time, the samples were sent to the provincial drug inspection and research institute for growth promotion test. after culture and inspection, no positive bottles were found. the verification results met the requirements and passed the on-site inspection smoothly. (Huang Lingxiao)
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