| Physical Monitoring Of Microbiology Laboratory |
1.0 OBJECTIVE To lay down the procedure on physical monitoring of Microbiology Laboratory. 2.0 SCOPE This procedure is applicable for the physical monitoring (Temperatures, RH and Differential pressure) in the Quality Control Department of Microbiology Area. 3.0 RESPONSIBILITY • Microbiologist analyst: is responsible for carrying out the established procedure. • Manager microbiology: is responsible for ensuring that the SOP is followed correctly. 4.0 ACCOUNTABILITY • Department Head To Read this SOP Click Here SOP for Cleaning, Operation and usage of dynamic pass box. 5.0 PROCEDURE 5.1 Monitoring of temperature and RH% in Microbiology Testing Area. 5.1.1 The measurement of temperature and relative humidity with the help of calibrated digital-hygro-thermometer in the area where temperature and relative humidity is required. 5.1.2 Microbiologist check the temperature and RH % shall be monitored twice in day. 5.1.3 Record temperature and relative humidity in format No. XXX. 5.1.4 If the temperature and RH% is not within limit, then inform to HVAC operator for take necessary action, do not perform any testing till the condition are maintained. 5.2 Monitoring of Differential Pressure in Microbiology Testing Area: 5.2.1 At a frequency of twice in a day, the differential pressure of the sterility testing area shall be monitored and recorded in format no. XXX. 5.2.2 The differential pressure of the Microbial Limit Testing area shall be monitored and recorded in format no. XXX. 5.2.3 The differential pressure of the bacterial endotoxin testing area shall be monitored and recorded in format no. XXX. 5.3 Action to be taken in case of physical monitoring results fail to meet specified limits: 5.3.1 If environmental monitoring results [Temperature, RH%, differential pressure, pressure in LAF/dynamic pass box are not complying from the specified limits Microbiologist shall immediately inform to the manager microbiology about the failure. 5.3.2 Manager microbiology shall inform engineering / maintenance personnel regarding the failure. The testing shall be stopped & resumed only after the physical monitoring results comply with the specified limits. 5.3.3 Investigation shall be done by maintenance department to find out the root cause of the failure and report shall be prepared with a preventive action plan. 5.4 If the physical condition of testing is not within limit, do not perform any testing till the condition are maintained. |
