Operation, Cleaning and Calibration of water bath
1.1 To lay down a procedure for Operation, Cleaning and Calibration of water bath.
2.1 This procedure is applicable for Cleaning ,Operation and Calibration of water bath in Quality Control Department
3.1 QC Officer or QC Executive
4.1 QC Manager
5.0 PROCEDURE (for operation and cleaning)
5.1 Check general cleanliness of the water bath and clean outer surface by lint free cloth .
5.2 Fill the purified water up to two third part of the water bath to properly dip the coil of heater.
5.3 Switch “ON” the main electric supply followed by switch “ON” the instrument, red indicator will glow on.
5.4 Adjust the temperature of the bath with temperature controller knob as per requirement.
5.5 When the required temperature of the bath reaches, the green light will be “OFF”
5.6 When a fix temperature is required for analysis then check the temperature with the help of calibrated
thermometer for verification.
5.7 Place the flask or beaker-containing sample on the bath as per the size & requirement for complete digestion .
5.8 When the operation completed switch “OFF” the instrument followed by switch “OFF” the main electric supply.
5.9 Remove the sample container from water bath carefully .
5.10 Maintained the record.
5.11.1 Operate the water bath according to procedure 5.1 to 5.6
5.11.2 Set temperature at 35°C and wait till temperature reaches, Take suitable calibrated thermometer and measure the temperature after, 1 hour , 2 hours and 3 hours.
5.11.3 Repeat the same procedure 5.11.2 for temperature 90°C.
5.11.4 Note down the observed temperature in Annex I.
5.12.1 Three months.
5.13 Acceptance Criteria
5.13.1 For temperature 35°C = ± 2°C.
5.13.2 For temperature 90°C = ± 2°C.
5.14.1 Ensure that there is sufficient water in water bath.
5.14.2 Instrument should be clean & free from dust.
Standard Operating Procedure
Calibration record of water Bath
Instrument ID: Date:
ID. No. of Thermometer :
Thermometer Calibrated On :
Thermometer Calibration Due :
Standard Operating Procedure
Calibration Status: The Instrument is calibrated as per Schedule/After Maintenance/Other (Specify) _________________ and
complies/does not comply with the predefined acceptance criteria and is suitable/not suitable for the routine usage.
Frequency: Quarterly (± 7 Days of Schedule date)
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sop for Retesting of packaging materials
sop for Retesting and resampling of raw materials
sop for Control of issuance of record of analysis green sheets
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sop for sampling of packaging materials PM
sop for sampling of sterile raw material
sop for sampling of intermediates and finished products
sop for operation and calibration of friability test apparatus
sop for approval and rejection of packaging materials
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sop for laboratory cleaning
sop for stability of volumetric solutions
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Entry and Exit in Quality Control Department