SOP Title: Operation, Handling and Cleaning of Stability Chamber
- Objective:
To lay down the procedure for Operation, Handling and Cleaning of Stability Chamber.
- Scope:
This SOP is applicable for Operation, Handling and Cleaning of Stability Chamber used to incubate stability samples located in stability section.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Operation, Handling and Cleaning of Stability Chamber as per this SOP.
- Engineering Department: To carry out preventive maintenance as per schedule and procedure defined.
- Quality Assurance Department: To review and approve the SOP and Annexures.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department
- Procedure:
| 5.1.1 | Stability chamber has 2 sensor located inside the stability chamber
1) Temperature sensor 2)Relative Humidity sensor |
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| 5.2 | Operation Of Stability Chamber | |
| 5.2.1 | Before switching on the chamber check the Water level of Water tank, which is attached to the back side of the chamber. | |
| 5.2.2 | Put the main plug in to the socket provided behind the chamber and switched ‘ON’ the main switch. | |
| 5.2.3 | Now switch on the “Mains” from the front panel by rotating the knob at ‘ON’ position. | |
| 5.2.4 | Now Temperature and Relative Humidity controller will glow and will display the set parameter. Set the desire value of temperature and Relative Humidity from controller display, as per define in operation manual. | |
| 5.2.5 | Set the safety controller temperature value above 2° C of set temperature, as mentioned in operation manual. | |
| Incubation of Stability Samples: | ||
| 5.3.1 | For the incubation of stability sample open the chamber door by provided key, keep the stability sample inside the chamber on trays. | |
| 5.3.2 | make the entries in respective stability register as per SOP of Sampling, Handling and Analysis of Stability Study Samples | |
| 5.3.3 | Do not over crowd the tray with more samples. | |
| 5.3.4 | Keep chamber always in lock and key. Only authorised and trained persons shall be allowed to open the chamber. | |
| 5.4 | Temperature and Relative Humidity Monitoring: | |
| Frequency : Daily Temperature and Relative Humidity monitoring shall be done twice a day | ||
| 5.4.1 | Daily Temperature and Relative Humidity Monitoring shall be done twice a day i.e. morning session and evening session as per Annexure. | |
| 5.4.2 | If Temperature and Relative Humidity found out of limit for more than 24 hours then file a incidence and investigate the cause of failure along with Engineering Department | |
| 5.4.3 | If breakdown occurs to stability chamber then inform Engineering department for further action. If required, contact service Engineer. | |
| 5.4.4 | Incubation shall be maintained at ± 2° C of the Specified temperature and ± 5% of the Specified Relative Humidity. The daily monitoring data shall be reviewed fortnightly basis to check any excursion occurs.
Any deviation as mentioned below must be assessed for impact and reported to the Head of QA Department. Refer SOP Procedure for Stability Study of Drug Product. Deviation of > ±2° C to ± 5°C from the set point for 48Hours. Deviation of > ±5% RH to ± 10% from the set point for 48Hours. Deviation of > ±5° C from the set point for 24Hours. Deviation of > ± 10% RH from the set point for 24Hours. |
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| 5.5 | Calibration Procedure: | |
| Frequency: Yearly Periodic Calibration by external agency | ||
| 5.5.1 | Periodic Calibration shall be done once in a year by external agency or after carrying out any major maintenance work. | |
| 5.5.2 | Calibration is carried out for set Temperature and Relative Humidity RH for 24 Hours at the time interval of 10 minutes. | |
| 5.5.3 | Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria. | |
| 5.5.4 | Update the “Instrument/Equipment Usage Log Book”, as per SOP and Update the “Annual Calibration Schedule” as per SOP. | |
| 5.5.5 | Affix the Calibration status label as per Annexure | |
| 5.5.6 | If Calibration activity is outsourced, the values are to be transcribed as per SOP, and external party certificate to be attached. | |
| 5.6 | Preventive Maintenance | |
| 5.6.1 | Perform the preventive maintenance monthly basis as per Annexure. | |
| 5.6.2 | If any breakdown occurs, follow procedure as per SOP “Calibration of Instruments and Equipments”. | |
| 5.7 | Cleaning of Stability Chamber: | |
| 5.7.1 | Stability chamber should be cleaned once a month. | |
| 5.7.2 | Floor, internal walls and exterior shall be cleaned with dry lint free cloth. | |
| 5.7.3 | All empty shelves shall be wiped with dry lint free cloth. | |
- Definitions / Abbreviations:
- Definitions:
- Breakdown: Any activity leading to operation of instrument/equipment other than the set parameters or unusual sound or vibration observed in the instrument/equipment.
- Calibration: Tests performed to ensure that the instrument/equipment is functioning as per set parameters. These tests are performed as per predefined frequency and also after any major repair or replacement of parts.
- Preventive Maintenance: Maintenance activity performed to ensure that the instrument/equipment will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.
- Abbreviations:
| Abbreviation | Expansion |
| °C | Degree Centigrade |
| RH | Relative Humidity |
| % | percent |
| v/v | Volume by volume |
| LED | Light Emitting Diode |
*Note – Ready to use SOP available in “DOWNLOAD” Section.