Lacto Helveticus,Lactobacillus Helveticus,Lactobacillus Helveticus Powder,Lactobacillus Helveticus Probiotic Jiangsu Biodep Biotechnology Co. ,Ltd. , https://www.mbioda.com
(1) All process equipment is capable of online cleaning (CIP) and online sterilization (SIP), all online cleaning (CIP) and online sterilization (SIP) processes can be verified;
a. The drying cabinet and vacuum condenser of the lyophilizer are required to have online cleaning (CIP) and online sterilization (SIP) functions;
b. Automatic feeding and unloading device (mobile feeding system AGV and fixed-row feeding system FixedRow-by-RowColdshelf) should have the function of one-way clean air flow protection semi-finished bottle mouth and online cleaning (CIP) and online sterilization (SIP) function.
c. The filling system of the filling machine's liquid chemical pipeline (including buffer tank) and filling needle should be able to successfully complete online cleaning (CIP) and online sterilization (SIP) before and after use. The structure of the RABS for environmental protection of the filling machine should be able to facilitate the entry of the rubber plug after sterilization.
(2) All filters used in the process of production will be tested for in-line integrity before and after use;
(3) All equipment is maintained at a positive pressure after sterilization. If the device is unable to maintain a positive pressure, all connections to the device have a container seal verification;
(4) All sterilization processes should have prior verification and revalidation arrangements;
(5) All connection ports of the equipment have container seal verification;
(6) After the containers, utensils and pipes have been sterilized, there is no unreliable aseptic connection and other operations throughout the aseptic production process;
(7) All process equipment has pre-maintenance;
(8) The aseptic filling system in the core area should be verified by the medium simulation operation (ASTM test).
The main purpose of core area engineering system integration is to increase the safety of drug production and improve work efficiency. On the basis of reliable quality of the drug itself, the unsafe factors in the production process are cross-contamination and human error. Therefore, the integrated production process in the core area is designed and verified according to the closed system concept. The basic concept of the closed system of the core area engineering integration should meet the following requirements: