SOP Title: Environmental Monitoring
- Objective:
To lay down the procedure for Environmental Monitoring of Microbiology Lab and Production Area.
- Scope:
This procedure is applicable for Environmental Monitoring of Microbiology Lab and Production Area.
- Responsibility:
3.1 Quality Control: To prepare and review the SOP. To follow the procedures for Environmental Monitoring of Microbiology Lab and Production Area as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexure.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department.
- Procedure:
| 5.1 | Safety Precautions: | |
| 5.1.1 | Microbiologist should wear hand gloves, nose mask and disinfect the hand gloves with 70% v/v IPA before carrying out operation. | |
| 5.2 | Procedure for plate exposure: | |
| Frequency: Every 15 days ± 3 days. | ||
| 5.2.1 | Refer Procedure for Media Preparation and Sterilisation – for preparation of Soyabean Casein Digest Agar plates. | |
| 5.2.2 | Pre Incubate these plates at 30-35°C for 24 hours in the incubator. | |
| 5.2.3 | Carry these pre-incubate SCDA plates through canister to Production Areas.
For Plate exposure locations, refer Annexure for location of plate exposure. |
|
| 5.2.4 | Expose pre-incubated sterile SCDA plates in classified areas at locations as per Annexure. Expose plates on a SS plate exposure stand, or any clean surface like instruments minimum above one feet from ground. | |
| 5.2.5 | Mark the plates with location number and date of exposure. | |
| 5.2.6 | Open the lid of plate and keep adjacent to plate on the exposing surface.
Never expose the plates on floor. |
|
| 5.2.7 | Expose these plates for two hours. | |
| 5.2.8 | At the end of the exposure time close the lid of plate and carry the plates in Microbiology section through canister. | |
| 5.2.9 | Incubates the plates at 20-25°C for 72 hours and continue the incubation at 30 to 35°C for 48 hours along with an unexposed plate as Negative control. | |
| 5.2.10 | After completion of specified incubation period, count the number of colonies on each plate. | |
| 5.2.11 | Ensure that the negative control does not show any growth otherwise the results are invalid in this case raise an incident report. | |
| 5.2.12 | Report the Total bacterial and fungal count observed in Environment Monitoring, refer Annexure. | |
| 5.2.13 | If the observed microbial count is exceed than the alert limit, intimate the concerned Department by forwarding the note through Quality Assurance Department. | |
| 5.2.14 | Stop the operation from the affected areas till further intimation by Quality Assurance. | |
| 5.2.15 | After necessary action taken by related Department, Microbiologist should repeat the Environment Monitoring activity for verification. | |
| 5.2.16 | Dispose off the Media plates by following the procedure given in SOP (Decontamination of Media and Cultures.) | |
- Definitions and Abbreviations :
- Definitions
- Abbreviations
| Abbreviation | Expansion |
| SCDA | Soyabean Casein Digest Agar |
| v/v | Volume by volume |
| % | Percentage |
| °C | Degree centigrade |
| ± | Plus or minus |
| IPA | Isopropyl Alcohol |
*Note – Ready to use SOP available in “DOWNLOAD” Section.