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Calibration Procedure for Disintegration Test Apparatus

  • Objective :To lay down procedure for Calibration of Disintegration Test Apparatus.
  • Scope :This standard operating procedure is applicable for formulation plant of pharmaceutical company name with Location.

Make: Electrolab.

  • Responsibility
    • Trained worker / Operator shall be responsible for operating of the equipment as per this SOP.
    • Production Supervisor / Officer shall be responsible for implementation of this SOP.
    • Head-Production / designee shall be responsible for compliance of this SOP.
  • Abbreviations and Definitions

SOP – Standard Operating Procedure

QA – Quality Assurance

  • Procedure
    • Calibration for number of oscillations per minute :
      • Take a pre-calibrated stopwatch. Operate the apparatus as per SOP. Start the apparatus and stopwatch simultaneously and count the number of oscillations per minute.
      • Repeat the same for five times and note down the number of oscillation per minute for each time.
      • The Oscillation per minute shall be within the limit of 29 to 32 through a distance of 53 to 57 mm throughout the period of operation. Record the observation in Annexure-1.
    • Calibration for temperature :
      • Switch on apparatus and press Key.
      • Turn on the heater by pressing ‘ON’ key.
      • Set the bath temperature by pressing scroll keys.
      • Wait till the temperature of Beaker A and Beaker B attain the set value.
      • Screen shall show the set temperature of bath and the temperature of Beaker A and Beaker B.
      • Take a pre calibrated thermometer and check the temperature of Beaker A and Beaker
      • Record the observation in Anexure-1.
    • Timer Calibration :
      • Set the timer for ‘30 minutes’ and start the equipment and stop watch simultaneously. Note down the stop watch reading immediately when the equipment stops and note the observation in Annexure-1. Observed time should not deviate by ‘± 1 min’ of set time.
    • Sieve Integrity Test :
      • Check the ‘Integrity’ of woven stainless steel cloth (sieve) attached to the base plate of each basket with a pre calibrated vernier caliper. The sieve has weaven squares of aperture of 1.8 – 2.2 mm and wire diameter of 0.57 to 0.66 mm. Note the observations in the Annexure-1.
      • Affix the ‘CALIBRATION STATUS’ tag duly filled and signed on the equipment after completion of calibration.
      • If the instrument is out of calibration then affix ‘UNDER MAINTENANCE’ tag and inform to maintenance department.
      • The frequency for calibration of Disintegration Test apparatus shall be after every one month or after every maintenance work.
  • Forms and Records
    • Disintegration Test Apparatus Calibration Record-Annexure-I
  • Distributions
    • Master Copy -Documentation Cell (QA)
    • Controlled Copies -Production and Quality Assurance
  • History
Date Revision

Number

Reason for revision
00 New SOP

                                                      Annexure-I

             DISINTEGRATION TEST APPARATUS CALIBRATION RECORD

Equipment ID :          

Frequency of Calibration:   Monthly  

Calibrated Stopwatch ID No. :                                  

Certificate No. :                                      Certificate Valid up to:

Calibrated Thermometer ID No.:                                  

Certificate No. :                                     Certificate Valid up to:

Calibrated Vernier Caliper ID No.:                                   

Certificate No.:                                      Certificate Valid up to:

PARAMETERS PARAMETERS SET   PARAMETERS OBSERVED ACCEPTANCE LIMITS
A B
Oscillations/ minute

( Basket )

—–     29 to 32 Oscillations/minute
   
   
   
   
Stroke Length

( Basket )

—–     53 mm to 57 mm
Temperature on Thermometer Bath 37.0°C   35°C to 39 °C
     Beaker  

 

 

 
Temperature Displayed on the screen Bath 37.0°C  
Beaker  

 

 

 
Timer 30 minutes      

± 1 Minute

 

Sieve Integrity:

 

SIEVE No.

 

                   BASKET A

 

                 BASKET B

 

Mesh Aperture

( 1.8 mm to 2.2 mm)

 

Wire Diameter

( 0.57 mm to 0.66 mm)

 

Mesh Aperture

( 1.8 mm to 2.2 mm)

 

Wire Diameter

( 0.57 mm to 0.66 mm)

1        
2        
3        
4        
5        
6        

 

CALIBRATION STATUS:  OK / NOT OK 

 

Calibration Date:                                                                  Calibration Due on:

 

Calibrated By:                                                                       Checked By:

Date:                                                                                       Date: 

 

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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