SOP for Calibration of Doses Uniformity Sampling Apparatus

1.0 OBJECTIVE : To set up a procedure for the calibration of Dose Uniformity Sampling Apparatus.

2.0 SCOPE : This procedure is applicable for the calibration of Dose Uniformity Sampling Apparatus in Quality Control Department of (Company Name).

3.1 QC Officer/Analyst shall be responsible to carry out the activity as per procedure.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his or her nominee.

4.1 Head of Quality

5.1 Ensure that the instrument is clean and dry before use.
5.2 Ensure that all the equipment viz. stop clock, pressure gauge are calibrated.
5.3 Ensure that the system is airtight.

6.1 Install a system according to following sequence.
Vacuum Pump Shut-off valve pressure gauge DUSA.

6.2 Close the DUSA at the input side by means of a locking cap.
6.3 Switch on vacuum pump and pressure gauge.
6.4 Adjust a vacuum of P0 (20 to 30 KPa) by means of the regulation knob at the vacuum regulator.
6.5 Close the shut-off valve.
6.6 Take a reading of the pressure display at the pressure gauge PA.
6.7 Switch off the vacuum pump.
6.8 Observe the display of the pressure gauge approximately 60 seconds. The display should be stable within the stated range.
6.9 Take a reading of the pressure display at the vacuum gauge PE.
6.10 In case of pressure loss, check all the system connections and repeat the test.
6.11 Input all data in the calibration report form as per Annexure-I.
6.12 Frequency: Two years ± 15 days.
6.13 Acceptance Range: Maximum 10 KPa

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