Standard Operating Procedure (SOP)

Here’s a comprehensive Standard Operating Procedure (SOP) for the Performance Check of a Low Temperature Water Bath. This SOP ensures the equipment operates within the required temperature limits for accurate laboratory use.

1. Purpose

To establish a standardized method for conducting a performance check of the low temperature water bath to ensure consistent and accurate temperature control.

2. Scope

This procedure applies to all low temperature water baths used in [Department/Laboratory Name] for analytical, stability, or sample storage purposes.

3. Responsibilities

• Lab Analyst/Technician: To perform and document the performance check.

• Quality Assurance (QA)/Lab Supervisor: To review and verify the results of the performance check.

4. Equipment & Materials

• Low Temperature Water Bath (Model: [Insert Model])

• Calibrated digital thermometer or temperature data logger (traceable to national standards)

• Stopwatch or timer

• Clean glass beakers or temperature probes

• Distilled water

• Logbook or performance check form

5. Safety Precautions

• Wear lab coat, gloves, and safety goggles.

• Avoid skin contact with cold surfaces to prevent cold burns.

• Ensure electrical safety—do not operate with wet hands or near water spillage.

6. Procedure

6.1 Pre-Check

1. Verify the water bath is clean, filled with appropriate liquid (distilled water or coolant as required), and powered on.

2. Allow the water bath to stabilize at the set point temperature for at least 30 minutes (or as per manufacturer’s instructions).

3. Ensure the temperature probe or sensor is calibrated and within the due date.

6.2 Performance Check Steps

1. Set the water bath to the desired temperature (e.g., 5°C, 0°C, or below depending on usage).

2. Allow the system to stabilize—monitor the display until the setpoint is reached and holds steady.

3. Place the calibrated thermometer or probe into the center of the bath (or as specified by manufacturer).

   • Ensure it is not in contact with the walls or base.

4. Record the temperature reading at time intervals:

   • At 0 min, 10 min, 20 min, and 30 min.

5. If applicable, repeat the test at multiple setpoints (e.g., -5°C, 0°C, +5°C) to verify performance across range.

6. Acceptable variation should be within ±0.5°C or as per specification.

7. Acceptance Criteria

• The temperature recorded should not deviate more than ±0.5°C (or as defined in user specifications) from the set temperature.

• No abnormal fluctuations should be observed during the monitoring period.

8. Documentation

Record the following in the performance check log:

• Date and time of test

• Operator name and initials

• Set temperature

• Observed temperature at defined intervals

• Calibration ID of thermometer used

• Observations/comments (if any)

• Signature of reviewer/QA

9. Frequency

• Monthly or quarterly (as per internal QA schedule)

• After servicing or repair

• After relocation of the unit

10. Troubleshooting

11. References

• Manufacturer’s Operation Manual

• ISO 17025 Guidelines

• Internal Quality System Manual

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