To lay down a procedure for environmental monitoring by settle plate method at production and microbiology lab
1.0 OBJECTIVE
1.1 To lay down a procedure for environmental monitoring by settle plate method at production and microbiology lab
2.0 SCOPE
2.1 This Sop covers the procedure of environmental monitoring by settle plate method at is applicable to all Production Blocks and Microbiology Labs.
3.0 RESPONSIBILITY
3.1 Microbiologist
4.0 ACCOUNTABILITY
4.1 Head –Quality Control
5.0 PROCEDURE
5.1 Prepare Soyabean Casein Digest agar (SCDA) and Sabouraud Dextrose agar (SDA) as per current version of GTP No.- XXXXX.
5.2 Aseptically dispense the media in Petri dishes.
5.3 After solidification invert and incubate the plates for 24 hours at 35°C.
5.4 Carry the plates in the Petri cans for plate exposing to the respective area.
5.5 Follow the entrance procedure available at that place and enter into the respective area accordingly.
5.6 Mark the Plates as per Point No given in Appendix’s according to respective block before wearing gloves.
5.7 Wear the hand gloves and clean the surface where plate has to be exposed by 70% isopropyl alcohol.
5.8 Open the plate carefully and keep the lid beside.
5.9 Expose the plates as per appendix – I, II, III, IV, V, and VI layouts.
5.10 Expose the plates for 120 minutes.
5.11 After completion close the plate by lid.
5.12 After exposing carry the plates in Petri cans to the microbiology lab.
5.13 Incubate both the soyabean casein digest agar plates at 35°C for 3 days and sabouroud dextrose agar plates at 22°C for 5 days.
5.14 Enter the details in miscellaneous register and assign AR. Number.
5.15 After incubation observe the plates for colonies and record the details in annexure-I. (Environmental monitoring by plate exposing.)
5.16 Frequency once a month and after any maintenance activity.
6.0 ALERT AND ACTION LIMITS
6.1 Microbiology / Production areas
6.1.1 Limits for total bacterial counts (CFU/Plate)
Area |
Class |
Alert Limit |
Action Limit |
|
A |
100 |
<1 |
<1 |
|
B |
1000 |
5 |
7 |
|
C |
10000 |
15 |
30 |
|
D |
100000 |
40 |
70 |
6.1.2 Limits for total fungal counts (CFU/Plate)
Area |
Class |
Alert Limit |
Action Limit |
|
A |
100 |
<1 |
<1 |
|
B |
1000 |
<1 |
<1 |
|
C |
10000 |
1 |
2 |
|
D |
100000 |
2 |
4 |
7.0 CONTROLS AND CHECKS
7.1 If the counts exceed the Alert limit inform to production in charge / house keeping in charge to increase the cleaning frequency by one fold up to one week.
7.2 If the counts exceed the Action limit inform to production in charge / house keeping in charge to change the disinfectant and clean the area twice a day for a week, simultaneously carryout the source and investigate.
END OF DOCUMENT
Environmental, microbiology, monitoring, plate exposing
