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Operating Procedure for Disintegration Test Apparatus

  • Objective:To lay down the Operating Procedure for Disintegration Time Apparatus.
  • Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location.

Make: Electro lab.

  • 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

TEMP – Temperature

OPTN- Option

LED – Light Emitting Device

  • Procedure
    • Operating Procedure:
      • Properly clean the equipment. Fill the water bath with potable water up to the marked level.
      • Put both the beaker in the water bath and fill with purified water, so that at the highest point of the upward stroke, the wire mesh remains at least 15 mm below the surface of the water and descends to not less than 25 mm from the bottom of the beaker on downward stroke.
      • Put the temperature probe in beaker slightly tilted of holding on the edge.
      • Attach the two baskets with magnet lock.
      • Switch ‘on’ the apparatus.
      • Idle screen shall display.
      • Select the desired mode and monograph.
    • Setting of Test time for individual monograph for dual time mode:
      • Press the ‘OPTN’ key from the front panel.
      • With this option light, date/time, print, configuration and protocol shall be changed.
      • Select the data with the help of F1 scroll key and for register press ‘Enter’ button, date and time can be changed by selecting scroll and arrow keys.
      • in time option set timer and view timing option can be changed by selecting scroll keys.
    • Setting of Temperature:
      • Press ‘Temp’
      • By using up and down scroll key  set the required temperature.
      • Press F1 key for heater ‘On’.
      • Temperature ‘LED’ on front panel shall glow and temperature screen shall be display on front panel.
      • Press enter’ key to register the value.
      • Press F2 key for heater ‘OFF’.
    • Illumination set up:
      • Press ‘optn’ Select ‘Light’.
      • Use Up and down scroll key to select ‘On / Off ’.
      • Press ‘enter’ key to register.
    • Print Set Up:
      • Press the ‘optn’ key from the front panel.
      • Select ‘Print’ using F1 key.
      • Press ‘enter’ printer shall start.
      • If there shall be an error, press again F1 key. It shall try again to print and by pressing F2 key print shall abort.
    • Halting Aborting Test:
      • Press Run / Halt key from the front panel, respective test to be halted of each basket.
      • The display shall show the elapse cumulative halt time of test being halted and respective basket perk out of the beaker.
      • To continue / aborting a test press Run / Halt key again a screen shall be displayed to continuing aborting the test.
      • Press F1 key for continuing / and by pressing F2 key, abort the test.
      • If F1 key is pressed it shall calculate cumulative time internally and start the test.
      • If F2 key is pressed than basket shall be aborted.
    • Error
      • Water Level:
        • When temperature is not achieved and heater cannot be ON. By pressing F1 key error indication is displayed that water level is not up to the mark.

Corrective action:  Come out by pressing enter key from the error screen and fill the water bath up to the marked level.

  • When the temperature of water bath is ± 0.5ºC from the set value test is stop. Wait for attain the required temperature.
  • When temperature controller is ‘OFF’ apparatus equipment also stop, than press enter key come out from error screen and ‘on’ temperature controller, wait till the wait temperature reach to the set value.
  • Registration Mode:
    • In this mode disintegration time for individual basket tube can be registered.
    • During the test as the individual disintegration of tablet takes place in a particular tube time Disintegration can be noted by pressing particular key for particular basket from the front panel.
    • In this mode if 6 keys of basket A/B pressed the basket shall perk out of beaker automatically.
    • User name can be entered with the help of keyboard after selecting the Time / Temperature as in dual m
    • Details of monograph can be prepared with the help of keyboard.
  • Forms and Records
    • Not Applicable
  • Distributions
    • Master Copy – Documentation Cell (QA)
    • Controlled Copies – Production  and Quality Assurance  
  • History

 

Date Revision

Number

Reason for revision
00 New SOP

 

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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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