STANDARD OPERATING PROCEDURE Operation and Calibration of Antibiotic Zone Reader

	STANDARD OPERATING PROCEDURE
	Department: Quality Control	SOP No.: QC/MB/xxxx
Operation and Calibration of Antibiotic Zone Reader		Effective Date:
		Review Date:
		Page No.: xxxx

1.0            OBJECTIVE:

1.1                   To lay down a procedure for Operation and Calibration of Antibiotic zone reader.

2.0            SCOPE:

2.1                   This Standard operating procedure is applicable for operation of antibiotic zone reader              located in microbiology laboratory at  Pharma Private Limited.

               I.D No.: xxx

               Make: In Lab Equipments.

3.0            RESPONSIBILITY:

3.1                 Microbiologist – Responsible for operation of the instrument.

3.2                 Section In-charge – Responsible for review of the procedure.

3.3                 QC Head – Responsible for implementing the procedure.

3.4                 QA Head – Overall compliance

4.0            PROCEDURE:

4.1                 Operating Procedure:

4.1.1             Switch on the Antibiotic zone reader.

4.1.2             Turn the right side drum anticlockwise to its maximum position, for the digital indicator to show zero reading or press the red button for zero indication.

4.1.3             Place the Petri dish on the rotating plate, rotate the petri dish manually, so that one end of the zone image just touches the mark line on the prism.

4.1.4             Now turn the right side drum slowly, in clockwise position till the other end of the zone image touches the mark line on the prism.

4.1.5             Note the readings shown on digital indicator. The digital indication is available from 0 to 35 mm.

4.1.6             Switch off the instrument when not in use.

4.1.7             Enter the usage details in Annexure – I (Antibiotic Zone Reader usage log sheet).

4.2                 Calibration Procedure:

4.2.1             Turn the right side drum anticlockwise to its maximum position, for the digital indicator to show zero reading or press the red button for zero indication.

4.2.2             Place the calibrated stainless steel /acrylic discs of known diameter (18mm) in petri dish on the rotating plate, rotate the petri dish manually, so that one end of stain less steel disc image just touches the mark line on the prism.

4.2.3             Now turn the right side drum slowly, in clockwise position till the other end of the stainless steel disc image touches the mark line on the prism.

4.2.4             Note the readings shown on digital indicator in Annexure II.

4.2.5             Now reset the digital display reading to zero by pressing reset button.

4.2.6             Likewise measure the other three disc of each of different diameter (20mm, 25mm and 27mm) and record the results in Annexure II “Calibration Report of Antibiotic Zone Reader”.

4.2.7             Acceptance Criteria:

4.2.7.1       The measured diameter shall be within the ± 0.2mm of calibrated diameter.

4.2.8             If antibiotic zone reader is failed to meet an acceptance criteria of calibration, then out of calibration shall be investigated as per current version of SOP QA/GN/xxx.

4.2.9             Calibration frequency: Quarterly ± 7 days or after any major maintenance work.

5.0            ABBREVIATIONS:

QC: Quality Control	QA: Quality Assurance
SOP: Standard Operating Procedure	mm: Milli Meter