Record of pressure in the microbiological laboratory in Pharma
Record of pressure in the microbiological laboratory in Pharma
To lay down the procedure of pressure record in the microbiological laboratory rooms.
It is for monitoring the pressure difference between rooms of the lab.
PROCEDURE:
The pressure difference between the rooms is determined by the laboratory using a manometer Magnehelic.
Before the account for the differential pressure make sure that the device attorneys of the state metrological service.
Make an inventory and registration of the pressure gauge closed doors of all laboratory rooms.
The procedure for registration or recording of the pressure difference between the lab twice a day, at the beginning and at the end of the working day.
| Acceptance Criteria | ||
| Sr.No. | Name of the room | Pressure, millimeters of water |
| 1. | Air-lock No.1- Corridor | > 1,0 |
| 2. | Air-lock No.2-Corridor of the laboratory | >1,0 |
| 3. | Media preparation room- Corridor of the laboratory | >1,0 |
| 4. | Corridor of testing rooms- Air-lock No.2 | >1,5 |
| 5. | Corridor of testing rooms -Media testing room | >2,0 |
| 6. | MLT room -Corridor of the testing rooms | >2,0 |
| 7. | Incubator room- Corridor of the laboratory | >1,0 |
REFERENCES:
Good manufacturing practice.
ABBREVIATIONS:
SOP: Standard operating procedure
QA: Quality Assurance department
MLT: microbial limit test.
