| Environment Monitoring In Microbiology Lab |
1.0 OBJECTIVE: 1.1 To lay down the procedure for the Environment Monitoring in Microbiology department. 2.0 SCOPE: 2.1 This procedure is applicable for the controlled area of Microbiology lab. 3.0 RESPONSIBILITY: 3.1 Microbiologist is responsible to followed procedure mentioned in this Standard operating procedure(SOP). 3.2 QC Head is responsible for implementation and compliance of the procedure as per this Standard operating procedure(SOP). 4.0 ABBREVIATIONS. 4.1 SOP : Standard Operating Procedure 4.2 QC : Quality Control 4.3 MLT : Microbial Limit Test 5.0 PROCEDURE: 5.1 Preparation of plates and other accessories: 5.1.1 Prepare required number of sterile SCDA (Soya bean Casein Digest Agar Medium) plates and give pre-incubation as per SOP. 5.1.2 Sterilize required number of SS carriers required to carry plates and other accessories to facility to be monitored. 5.1.3 Place the Pre-incubated media plates at 30-35°C for 24 hours in micro lab. 5.1.4 Label the required plates on bottom side name of media, media Lot no., Location Code, sign (Initial) and date. 5.1.5 Start the monitoring using the procedure mentioned below. 5.2 Settling Plates Exposure 5.2.1 Expose the agar medium plates at the locations according to the pre-defined locations. 5.3 Exposure Method 5.3.1 Bring each plate to the pre-defined locations. 5.3.2 Open the lid of plate carefully. 5.3.3 Place the plate containing medium in the location .Place the plate on the settle plate exposure stand if it is provide for that location. 5.3.4 Place the lid beside this plate internal side down. 5.3.5 Expose the plate for not more than (NMT) 2 hours. 5.3.6 After Completion of exposure time, close the medium plate with lid carefully. 5.3.7 Bring all the medium plates for incubation. 5.3.8 Make the entry in the respective formats XXX. 5.4 Incubation 5.4.1 Incubate all plates of environmental monitoring at 20-25°C for 72 hours and at 30-35°C for further 48 hours in micro lab. Observe the plates after 72 hours and after further 48 hours and record the results in respective formats XXX. 5.5 Frequency 5.5.1 Settle plate exposure once in a week. 5.6 Acceptance criteria : CLASS 100 CLASS 10,000 CLASS 100,000 Alert Level — 30 40 Action Level 1 50 60 5.7 TEMPERATURE MONITORING 5.7.1 Monitor the temperature in the MLT area, media preparation room and media store room by using the calibrated thermometer. 5.7.2 Record the observations in the record as per the format XXX. 5.7.3 Acceptance criteria: NMT 25ºC ±2°C. 5.8 DIFFERENTIAL PRESSURE MONITORING. 5.8.1 Differential Pressure Monitoring is monitored in MLT testing area and supported areas and records the observations in the record as per the format XXX. 5.9 NON-VIABLE AIR BORNE PARTICLE COUNTS. 5.9.1 External agency shall be hired for Monitoring of the Non-Viable Air Borne Particle Counts. 5.9.2 Frequency for Monitoring of the Non-Viable Air Borne Particle Counts is once in a Half Year. |
