Drugsformulations
SOP on cleaning, maintenance and calibration of stability chamber
Objective:
- To lay down a procedure for Cleaning, maintenance and calibration of stability Chamber.
Scope:
- This SOP is applicable for the cleaning, maintenance and calibration of stability chamber
Responsibility:
- QC Chemist or above
- Electrician or above
Accountability:
- Head – Quality Control
- Head – Engineering
Procedure:
Cleaning:
- Chamber shall be cleaned from outside daily.
- Boiler tank shall be cleaned weekly or after maintenance.
- Water reservoir tank shall be cleaned weekly or after maintenance.
- Boiler heater shall be cleaned weekly or after maintenance.
- PT-100 sensor tip shall be cleaned with the help of polish paper in 3 month.
- Condensor, condensor motor and radiator shall be cleaned in 3 month with the help of blowing air.
- Control panel shall be clean by blowing air in 3 month.
- Cleaning record of the stability chamber shall be maintained as per Annexure No. A01
Maintenance :
- Any problem in stability chamber shall be intimated to Engineering department and fill the maintenance work permit as per Annexure No. A02.
- Chamber fan and condensor fan shall be checked in three months. If found loose,tighten it.
- Working of safety cut off shall be checked in 3 month by giving external heat to the dry bulb sensor.
- Maintenance shall be done if any problem appears in the chamber.
- Preventive maintenance of stability chamber shall be done by the service engineer in 3 months and record shall be maintained as per Annexure No. A06.
- If any abnormality observed by service engineer then action for rectification shall be done immediately.
- Water level of the reservoir tank as well as of the main tank shall be checked at the start of shift and at end of shift.
- Maintenance record shall be maintain as per Annexure No A02
Calibration:
Calibration of the stability chamber shall be done by outside party once in a year.
Calibration shall be reported as per Annexure No. A02
For Other Pharma Related Post and Updates Click Here
List of Annexure / Format :
| Sr. No. | Format Title | Annexure Number |
| 1 | Stability Chamber Cleaning Record | A01 |
| 2 | Stability Chamber Maintenance Record | A02 |
| 3 | Stability Chamber calibration Record | A03 |
References :
- If any
Reason for Revision :
- Not applicable due to first version of SOP
Abbreviation :
- QC : Quality control
- SOP : Standard Operating Procedure
Annexure 1
Stability Chamber cleaning Record
Stability chamber Id. No.:
| Sr. No. | Date
| Chamber | Boiler tank | Boiler Heater | Reservoir tank | PT-sensor tip | Condensor | Condensor motor | Chamber fan | Condensor fan | Cleaning done by | Checked by
| Remarks
|
Annexure 2
Stability chamber maintenance record
Stability chamber Id. No. : Date :
| Stability Chamber Model No. | Capacity | ||
|
| |||
| Problem Identified : Action for rectification : Is calibration required after maintenance : Remark ( if any ) : | |||
| Service Engineer ( Sign / Date ) | Checked By ( Sign / Date ) | Approved By ( Sign / Date ) | |
Annexure 3
Calibration record of stability Chamber
Stability chamber Id. No.:
Calibration Done On : Next Calibration due On :
| Set Temperature | Actual Temperature | Calibrator Temperature |
| Set RH | Actual RH | Calibrator RH |
The above equipment has been found / not found within the permissible limits for temperature ±2°C and for relative humidity ±5% and hence acceptable.
Calibrator Details :
| Calibrator No. | Detail of Calibrator | Calibration Details | Calibration due date |
Remark if Any :
Instrument Calibration comply / does not comply.
| Reported By / Date | Checked By / Date | Approved By / Date |
