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SOP For Calibration of Disintegration Test Apparatus

This standard operating procedure outlines the calibration process for a disintegration test apparatus. The calibration is conducted monthly and involves measuring the temperature of individual beakers to ensure they are at 37°C. The number of up and down cycles per minute are also recorded. Readings are recorded in a form and the apparatus is checked against limits specified in an annex. The calibration process is the responsibility of a technical assistant and ensures the proper functioning of the equipment used for quality testing.

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Solomon Gamanuel
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1K views3 pages

SOP For Calibration of Disintegration Test Apparatus

This standard operating procedure outlines the calibration process for a disintegration test apparatus. The calibration is conducted monthly and involves measuring the temperature of individual beakers to ensure they are at 37°C. The number of up and down cycles per minute are also recorded. Readings are recorded in a form and the apparatus is checked against limits specified in an annex. The calibration process is the responsibility of a technical assistant and ensures the proper functioning of the equipment used for quality testing.

Uploaded by

Solomon Gamanuel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 3

Company Name:: Version No.

Humanwell Pharmaceutical Ethiopia PLC 1


Title:

Document No: Page No.


SOP/QC/009 Page 1 of 3
SOP for Calibration of Disintegration Test Apparatus

Effective Date Revision Date

SOP for Calibration of Disintegration Test Apparatus

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:

Document No: Page No.


SOP/QC/009 Page 2 of 3
SOP for Calibration of Disintegration Test Apparatus

Effective Date Revision Date

This procedure defines procedure to calibrate the disintegration test apparatus

2. Scope

This procedure is to to disintegration test apparatus, installed in quality control department.in


Validity

This SOP is valid only until next revision date and if it bears control seal.

3. Responsibility

It will be the responsibility of Technical Assistant to follow the procedure. Quality assurance
manager is responsible for SOP compliance.

4. Material and Equipment

Disintegration apparatus

6. Procedure:
Frequency: Once in a month
6.1. Operate the instrument as per standard operating procedure.
6.2. When indicator display 37°C, measure the temperature of individual beaker with
thermometer and record the results in Form SOP/QC/009/F/01
6.3. Also record the number of up down cycles per minute. Note down four reading for each
bath and record the results in Form SOP/QC/009/F/01.
6.4. Also measure the oscillation and record the results in Form SOP/QC/009/F/01
6.5. If the instrument is out of limit as in Annexure-I, follow the S.O.P. Note: Each
instrument is calibrated with the respective serial number bath. Do not interchange the bath.

7. Abbreviations
 O
C = Degree centigrade
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:

Document No: Page No.


SOP/QC/009 Page 3 of 3
SOP for Calibration of Disintegration Test Apparatus

Effective Date Revision Date

 No. = Number
8. Related Documents /Applicable document/

Related Title
Documents./
SOP/QC/009 /F01 Operational Check Report Form of Disintegration Test
Apparatus

9. Revision History

Version
Revision Description
No.

1 New

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