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PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER

1.0       OBJECTIVE

To lay down the procedure for operation and cleaning of unit dose sampler.

2.0     SCOPE

This SOP shall be applicable for IPQA area in Quality Assurance.

            3.0       RESPONSIBILITY

In process Quality Assurance Executive /Officer

4.0       ACCOUNTABILITY

Head Quality Assurance

5.0       PROCEDURE FOR OPERATING

5.1       Check the Status label of the sampler.

5.2       Remove the polythene film covered to the sampler.

5.3       Check the conical end piece attachment to the outer tube.

5.4       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

5.5       Insert the solid blank dies in the remaining cavities.

5.6       Turn the inner shaft at slot 2 in closed position.

5.7       Insert the sampler in to the material to be sampled.

5.8       Turn the inner shaft at slot 2 to open position and let the material filling to the first set of dies.

5.9       Turn the outer tube to close the dies

5.10     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.

 

  • PROCEDURE FOR CLEANING 
  • 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’.

 

 

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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