OBJECTIVE:
To lay down the procedure for operation of Water bath (Make: Cintex; Model: GMP model-CIC-2BM).
SCOPE:
This SOP is applicable for the procedure for operation of Water bath (Make: Cintex; Model: GMP model-CIC-2BM) at {Company Name} {Location}.
RESPONSIBILITY:
In charge- Microbiology- is responsible to ensure compliance as per SOP.
Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
ABOUT WATERBATH:
In a microbiology lab , water baths are indispensable for maintaining precise temperatures. They are crucial for incubating cultures, conducting enzymatic assays, and warming reagents. The consistent temperature control ensures optimal conditions for microbial growth and biochemical reactions, which is vital for drug development and quality control. Water baths are favored for their ability to provide uniform heating, preventing localized hot spots that could harm sensitive samples. Their applications range from culturing microorganisms to performing various temperature-sensitive tests in pharmaceutical research and quality assurance. In the pharmaceutical industry, water baths also play a vital role in various processes like drug dissolution testing, which determines how quickly a drug releases its active ingredient, and stability testing, where drug products are kept at specific temperatures to assess their shelf life and efficacy.
PROCEDURE:
Operation:
Daily clean and replace the water with purified water until the water level touches the sensor.
Switch on the mains in the control panel.
Red indicator light glows.
Temperature controller displayed with process value (PV) in red and set value (SV) in yellow.
To set the required temperature press “▲”, “▼” and “◄” keys on the control panel.
Press ▲to increase the temperature, ▼ to decrease the temperature and ◄ key to move the digit expected to modify.
Switch on the booster switch.
Green light glows until the set value reaches.
Operate the water bath between 0 to 99°C.
Keep the sample on the tray provided.
After use switch off the mains.Keep the loc in 0-1 which allows modifying the set temperature.
Enter the usage of the instrument in the format – I.
REFERENCE:
Not applicable
ANNEXURES:
| ANNEXURE NO. | TITLE OF ANNEXURE |
| Annexure-I | Water Bath usage log book |
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Master Copy : Quality Assurance Department
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Quality Control (Micro.)
ABBREVIATIONS:
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| QC | : | Quality Control |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Annexure-I
Water Bath usage logbook
