To lay down a procedure for Environmental Monitoring of Class 1,00,000 areas
1.0 OBJECTIVE:
To lay down a procedure for Environmental Monitoring of Class 1,00,000 areas
2.0 SCOPE:
This procedure applies to the Environmental Monitoring in Class 1,00,000 areas of Module – I, II and III.
3.0 RESPONSIBILITY:
Microbiologist: To perform as per SOP.
Head – QC & Head – QA : To ensure the compliance of SOP
4.0 PROCEDURE:
4.1 Preparation of plates: For preparation of media plates, follow the steps as per Respective sop.
4.2 Settle plate Method:
4.2.1 Prepare Soyabean casein digest agar plates as per Respective sop.
4.2.2 Perform the growth promotion test for medias as per Respective sop.
4.2.3 Method:
4.2.3.1 Carry these plates in stainless steel petrican / bin previously wiped with 70% v/v IPA to the respective Areas / department.
4.2.3.2 Follow the gowning procedure as required by the respective department to avoid additional contamination.
4.2.3.3 Disinfect the hands with IPA 70% v/v, wear the sterile surgical gloves.
4.2.3.4 Take out the plates from container, carry each plate and stand to its location, clean the SS stands with 70% IPA, open the lid and place the plates in predetermined position on the stand for 4 hours as per the Appendix- I.
4.2.3.5 At the end of exposure period, close the plates, kept them in SS Box and transfer to Micro department and assign analytical reference No. as per current version Respective sop.
4.2.3.6 Incubate the SCDA plates at 20°C to 25°C for 72 hours in BOD incubator.
4.2.3.7 After completion of 72 hours, incubate same plates at 30 to 35°C for 48 hours in BOD incubator.
4.2.3.8 Keep the negative control along with the exposed plates in the incubator.
4.2.3.9 Take the total no. of colony forming unit (cfu) observed after completion of 120hours.
4.2.4 Frequency:-Once in a week.
4.2.5 Precaution:
4.2.5.1 Ensure that plates are exposed for not less than 4 hours.
4.2.5.2 Ensure that plates are pre incubated and SS Stands are cleaned.
4.2.6 Limit:
Class Maximum Limit
Class1,00,000(Grade D) ?100 cfu/ 4hours/ plate
4.3 Air sampling method
4.3.1 Take the Air sampler, perforated sieve and pre-incubated plates in SS box /petrican which is previously wiped with 70% v/v IPA to the respective areas.
4.3.2 Follow the gowning procedure as required by the respective department to avoid additional contamination.
4.3.3 Disinfect the hands with 70% IPA v/v, wear the surgical gloves.
4.3.4 Place the air sampler in predetermined position on the floor.
4.3.5 Place the pre incubated plate on the top of the dish support
4.3.6 Remove the lid of the plate and fix the perforated sieve then it is locked.
4.3.7 Operate the Air sampler as per Air sampler Respective sop.
4.3.8 Remove the sieve the tester and close the plates with it’s lid.
4.3.9 Continue the sampling for all predetermined positions as per the
4.3.10 All sampled plates are kept in SS Box and transfer to Micro department and assign analytical reference No. as per current version of Respective sop.
4.3.11 Incubate the plates at 20°C to 25°C for 72 hours in BOD incubator.
4.3.12 After completion of 72 hours, incubate same plates at 30 to 35°C for 48 hours in BOD incubator.
4.3.13 Keep the negative control along with the exposed plates in the incubator.
4.3.14 After completion of incubation period count the number of colonies on the plate and report the colony forming unit per cubic meter.(cfu/ m3)
4.3.15 Frequency: Once in a week.
4.3.16 Limit:
|
Class |
Maximum Limit |
|
Class1, 00,000(Grade D) |
<200 cfu/ m3 |
4.3.17 Note :- Environmental monitoring by settle plate method, air sampling method shall be done during operation or activity in the area.
4.3.18 Environmental Monitoring locations shall be identified as EM/SP/NN
Where EM – Environmental Monitoring.
SP – Sampling point
NNN – Serial No. i.e. 01,02,03…. like wise.
Environmental, microbiology, bod incubator
