SOP for Microbiological Qualification of Area
1.0 OBJECTIVE :
- To describe the procedure for the qualification of new or renovated / modified Manufacturing Area.
2.0 SCOPE :
- This SOP is applicable for evaluation of viable count in the environment.
3.0 RESPONSIBILITY :
- Microbiologist
4.0 ACCOUNTABILITY:
- Head of Department and Quality Assurance Head
5.0 PROCEDURE :
5.1 When the manufacturing area is ready with respect to construction, air supplies, equipment installation, clean the floors, equipments, walls ceiling, and other textures as per SOP for Production Department.
5.2 Prepare SCDA agar, autoclave at 121°C for 15 lbs for 15 min and after completion of autoclave pour the agar into sterile Petri plate and keep for pre incubation for 18-24 hour.
5.3 Refer table for sampling points: working on number of settle plate in different area.
| Area of cleanroom (m2) less than or equal to | Minimum number of sample locations to be tested |
| 2 | 1 |
| 4 | 2 |
| 6 | 3 |
| 8 | 4 |
| 10 | 5 |
| 24 | 6 |
| 28 | 7 |
| 32 | 8 |
| 36 | 9 |
| 52 | 10 |
| 56 | 11 |
| 64 | 12 |
| 68 | 13 |
| 72 | 14 |
| 76 | 15 |
| 104 | 16 |
| 108 | 17 |
| 116 | 18 |
| 148 | 19 |
| 156 | 20 |
| 192 | 21 |
| 232 | 22 |
| 276 | 23 |
| 352 | 24 |
| 436 | 25 |
| 500 | 26 |
| 1000 | 27 |
| >1000 | Equation A |
Equation A — N = 27 (area) / 1000
5.4 The larger the room the more sampling locations that must be taken.
5.5 Select the number of sampling locations as per GMP Guideline.
5.6 Evenly distribute the sample locations within the area under test and at a position related to the working activity. Expose the plate for 4 hours using settle plate technique method.
5.7 Incubate all these plates at 20°C to 25°C for 3 days for fungal count and 30°C to 35°C for 2 days for bacterial count.
5.8 Give Virosil disinfectant treatment, if count is exceeding the limit then again clean the area as per standard procedure & repeat the exercise for 3 successive days.
5.9 Allow the area for production for regular process if the count are within limit.
5.10 LIMITS :
- Action limit for viable count in air
- In unmanned condition (at rest) : 100 cfu/plate
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| SCDA | Soya bean Casein Digest Agar |
| cfu | Colony Forming Unit |
| Min | Minutes |
| °C | Degree Celsius |
7.0 ANNEXURES:
| Annex. No | Title |
| 01 | Working on Number of Settle Plate in Different Areas. |
8.0 SOP REFERENCES
- GMP Guideline
END OF THE SOP
ANNEXURES :
Annex. No. 01 Working on Number of Settle Plate in Different Areas
