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Calibration procedure for tap density apparatus [Make- electro Lab]. Quality assurance

  • OBJECTIVE
  • To lay down the procedure for Calibration of Tap density apparatus, Make – Electro lab.
  • SCOPE
  • This SOP shall provide the Calibration procedure of Tap density apparatus of quality control department.
  • RESPONSIBILITY
  • Officer/ Executive – Quality Control
  • ACCOUNTABILITY
  • Head QC/QA
  • PROCEDURE
  • Before starting the operation check for the area cleanliness and instrument cleanliness.
  • Connect the pin to power supply and switch on the power.
  • Operate the instrument as per sop no BA (II) QA210, operation of Tap density apparatus.
  • The instrument shall be calibrated for the following parameters.
  • (a) The drop height of the cylinder holder.
  • (b) The number of drops per Minute of cylinder holder.
  • Calibration of Drop height of cylinder holder for USP method 1:

    • Open the top cover by removing bottom screws.
    • Turn the cam attached to the motor shaft clock wise, so that the cylinder holder shaft is at the minimum position.
    • Make sure that the bottom plate of the cylinder holder is in perfect contact with the tapping platform.
    • Measure the distance between the platform and the clamp plate of cylinder holder; this reading is the base height (Hr).
    • Rotate the cam further by hand, clockwise till the cylinder holder shaft reaches maximum height.
    • At this position the shaft tip should be on the falling edge of the cam arm. Mark this arm no -1.
    • With a digital Vernier caliper measure the distance between the top plate of frame and clamp plate of cylinder holder.
      This is height H1.
    • Make a mark on the point of measurement on the top plate of frame and on the cylinder plate.
    • The difference between these two readings is drop height of the cylinder.
    • Mark arms 1, 2 and 3 and heights H1, H2, H3 and so on. Repeat the above procedure for all arms.
    • Make sure that the point of measurement on the platform and on the cylinder holder plate is maintained the same for all measurements.
    • Record the results in the given format (Annexure 1).
    • Calibration of Drop height of cylinder for USP 2 method.
    • Repeat the above all steps for all arms and record the results in the given format.
  • Calibration for Number of drops of cylinder holder per minute:

    • Set the instrument as per USP 1 method and operate the instrument.
    • Paste a small piece of Metal reflection paper on cam.
    • Focus the light of tachometer on metal reflection paper sharply at a distance about 20cm approximately.
    • Multiply the rotation per minute which is displaying in tachometer by three and record the values in calibration format.
    • Repeat the operation for 3 times and check the set number of tapings and record the values in calibration format.
    • The number of drops should be between 300 ± 6 drops.
    • Similarly set the instrument as per USP 2 method and operate the instrument.
    • Multiply the rotation per minute, which is displaying in tachometer by four and record the values in calibration format.
    • The number of drops should be 250 ± 5 drops.
    • Enter the details of calibration in log book.
  • Forms and Records (Annexures)
  • Instrument calibration Format Bulk Density Test Apparatus – Annexure-1
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    Date Revision Number Reason for Revision
    00 New SOP

             

   Annexure-1

   Instrument calibration Format Bulk Density Test Apparatus

Make : Instrument No. :
Model : Calibration Date :
SOP reference No. : Next due date :
DROP HEIGHT OF CYLINDER:                               Vernier caliper reference number:                              
USP – 1 USP – 2
Big holder Arm

1

H1

Arm

2

H2

Arm

3

H3

Tolerance limit Arm

1

H1

Arm

2

H2

Arm

3

H3

Arm

4

H4

Tolerance limit
HI
HR
Drop Ht

(HI – HR)

12 to 16mm 2.7 to 3.3mm
USP – 1 USP – 2
Small holder Arm

1

H1

Arm

2

H2

Arm

3

H3

Tolerance limit Arm

1

H1

Arm

2

H2

Arm

3

H3

Arm

4

H4

Tolerance limit
HI
HR
Drop Ht

(HI-HR)

12 to 16mm 2.7 to 3.3mm
NUMBER OF DROPS /MINUTE:
Method Observed drops /minute Tolerance Limit (± 2.0 %)
USP-1 294 to 306 drops
USP-2 245 to 255 drops
CALIBRATION STATUS: COMPLIES / DOES NOT COMPLIES.

Calibrated by:                                                     Checked by:                                                        Approved by  :

Date      :                                                               Date       :                                                              Date              :

 

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