SOP on Procedure for operation and cleaning of unit dosage sampler

  • SOP on Procedure for operation and cleaning of unit dosage sampler
  • To lay down the procedure for operation and cleaning of unit dose sampler.
  • This SOP shall be applicable for IPQA area in Quality Assurance.
  • In process Quality Assurance Executive /Officer
  • Head Quality Assurance
  • Check the Status label of the sampler.
  • Remove the polythene film covered to the sampler.
  • Check the conical end piece attachment to the outer tube.
  • Take out the inner shaft from outer tube and insert three dies into the die receiving cavity as per sampling plan of the respective product
  • Insert the solid blank dies in the remaining cavities.
  • Turn the inner shaft at slot 2 in closed position.
  • Insert the sampler in to the material to be sampled.
  • Turn the inner shaft at slot 2 to open position and let the material filling to the first set of dies.
  • Turn the outer tube to close the dies
  • Pull the inner shaft up to slot 1 position.
  • Remove the individual dies by pushing them from the die receiving cavity on the inner shaft using the die retrieval tool provided with the sampler and empty the powder onto the butter paper and transfer the powder into  pre labeled  polybags and seal.
  • After completion of sampling, label it as ‘to be cleaned’ and keep in washing area.
  • Remove all the dies, slots and inner shafts from the outer shaft.
  • Clean the above parts with soft water at initial stage. Finally rinse with purified water.
  • Wipe off with lint free cloth before placing under hot air.
  • Visually inspect the above parts,if satisfactory reassemble them.
  • Finally place the sampler in fresh polythene film and label it as ‘ready for use’.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality
  • History
    Date Revision Number Reason for Revision
    00 New SOP

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