SOP for Micrometer : Pharmaguideline

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SOP for Micrometer

Standard operating procedure of Micrometer used in Quality Control.

1.0 OBJECTIVE

To describe the procedure for operation of Micrometer.

2.0 SCOPE

This SOP is applicable for operation of Micrometer.

3.0 RESPONSIBILITY

Officer/ Executive - Quality Control

4.0 ACCOUNTABILITY

Manager – Quality Control

5.0 PROCEDURE

5.1 Operating procedure

5.1.1 Turn the thimble to gently bring the spindle in to contact with the anvil. Apply the rated measuring force using the ratchet stop/friction thimble.
5.1.2 Press the zero buttons to zero setting display 0.0000 on the screen.
5.1.3 To 0.0000 setting indicating the origin has been set.
5.1.4 To set the required measurement value. Press IN/MM changeover buttons.
5.1.5 Note the reading.

5.2 Cleaning procedure

5.2.1 Clean measuring jaws holding disks with a slightly wet cloth and then with a dry cotton cloth.
5.2.2 Clean measuring jaws holding disks with a dry cotton cloth whenever required during and after the test.

5.3 Calibration procedure

5.3.1 Calibration of micrometer following standard calibrate equipment are as follows
          Standard slip gauge       Standard metal gauge block
          Asset No.                     -------------------         --------------------
          Make                           Mitutoyo                        Mitutoyo
          Capacity                       0.05mm to 1.00 mm      Width 25.00mm, length 34.90mm hight 8.9mm
          Location                       QC Laboratory              QC Laboratory
          Calibrated by -             External party                 External party
          Calibration frequency-  Once in two years.         Once in two years

5.3.2 Calibration can be done in-house or by the external party.
5.3.3 For micrometer press on key with the jaw closed.
5.3.4 Ensure “zero”reading with the jaw closed.
5.3.5 Open the jaw.
5.3.6 Measure the thickness of standard slip gauge (0.05 mm to 1.00 mm) by putting individual gauge between the jaw.

5.3.7 Note the observations in Annexure I. Annexure I is not applicable if the calibration is done by outside party.
5.3.8 Measure the length, width and height standard metal gauge block (8.90 mm, 25 mm and 34.90 mm respectively) by putting the standard metal gauge block in between the jaws.
5.3.9 Note the reading in Annexure I. Annexure I is not applicable if the calibration is done by outside party.
5.3.10 Affix the calibration status label.
5.3.11 Frequency of Calibration: Once in two years by the external party.
5.3.12 If calibration is out of calibration then inform to head of the department for further action.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 No. - Number
6.3 QA - Quality Assurance
6.4 NA - Not Applicable
6.5 CCF - Change control format
6.6 QC - Quality Control


ANNEXURE-I
CALIBRATION OF MICROMETER
Asset ID  No.
:

Ref.  SOP No.
:

Make
:

Model No.
:

Date:
S.No
Nominal size in mm (slip gauge)
Tolerance in mm (±5% of nominal size in mm)
Observed value in mm
Calibrated by
Checked by
Remark
1
0.05
0.048-0.052




2
0.10
0.095-0.105




3
0.15
0.143-0.157




4
0.20
0.190-0.210




5
0.25
0.240-0.260




6
0.30
0.285-0.315




7
0.35
0.340-0.360




8
0.40
0.380-0.420




9
0.45
0.430-0.470




10
0.50
0.475-0.525




11
0.55
0.530-0.570




12
0.60
0.570-0.630




13
0.65
0.620-0.680




14
0.70
0.665-0.735




15
0.75
0.720-0.780




16
0.80
0.760-0.840




17
0.85
0.810-0.890




18
0.90
0.855-0.945




19
0.95
0.910-0.990




20
1.00
0.950-1.050




Date :
S.No.

Nominal size standard metal gauge block mm
Tolerance in mm
Observed value in mm
Calibrated by
Checked by
Remark
1
Width=25.00mm
23.75-26.25




2
Length=34.90mm
33.20-36.65




3
Height=8.90mm
8.50-9.35




Remark:  For micrometer least count 0.05mm use slip gauge measurement 0.20mm to 1.00mm and use metal gauge block.
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