Cleaning of Unit Dose and Large Volume Sampling Thieves

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  • OBJECTIVE :
  • To lay down the procedure for cleaning of unit dose and large volume sampling thieves.
  • RESPONSIBILITY :
  • Executive -Quality Assurance to implement the procedure.
  • Head – Quality Assurance to ensure compliance.
  • PROCEDURE :
  • Preparation of Detergent solution (2% Extran MA 02 Neutral, solution):
  • To about 980 mL of potable water in plastic beaker add about 20 mL of Extran and mix thoroughly.
  • Preparation of 70% Iso propyl alcohol:
  • To about 300mL of purified water add about 700mL of Isopropyl alcohol and mix thoroughly.
  • Procedure for Large Volume Sampling Thieves:
  • Separate the inner and outer tubes of the sampler.
  • Dry wipe any powder sticking to the tubes with a clean cloth.
  • Wash the inner and outer tubes with potable water to remove any residues.
  • Scrub the outer and inner tubes with about 0.5 ltr. of Detergent solution, using a long handled nylon brush.
  • Remove any residues of powder sticking to the corners of the partitions in the inner tube  using a  nylon brush.
  • Thoroughly wash the inner tube and outer tubes with ample amount of potable water to remove detergent residue.
  • Rinse the inner and outer tubes  with about a litre of Purified water.
  • Wipe dry the tubes with a clean cloth.
  • Rinse the tubes with 70% Isopropyl alcohol solution and allow to dry preferably in a hot air oven maintained at 80°C, for about 30 minutes.
  • Inspect visually for any residues, if any residues observed repeat the cleaning .
  • After cleaning is complete, keep the sampler in its respective case or wrap it in a clean polybag.
  • Procedure for Unit dose  Sampling Thief and dies:
  • Separate the inner and outer tubes of the sampler and take out the dies from the sampling ports.  Remove the conical head at the tip of the outer tube.
  • Dry wipe any powder sticking to the tubes and dies with a clean cloth.
  • Wash the inner and outer tubes with potable water to remove any residues.
  • Wash the dies with potable water to remove any residues.
  • Soak the dies and conical end in about 0.5 ltr. of detergent solution for about 30 minutes.
  • Scrub the outer and inner tubes with about 0.5 ltr. of Detergent solution, using a long handled nylon brush.
  • Remove any residues of powder sticking to the corners of the dies, using a nylon brush.
  • Thoroughly wash the inner tube, outer tube, dies and end cone  with ample amount  of potable water to remove detergent residue.
  • Rinse the inner and outer tubes  with about a litre of Purified water.
  • Wipe dry the tubes, dies and end cone with a clean cloth.
  • Rinse the tubes, dies and end cone with 70 % Iso propyl alcohol solution,  and allow to dry  preferably in a hot air oven maintained at 80°C, for about 30 minutes.
  • Inspect visually for any residues, if any residues observed repeat the cleaning.
  • Fix the end cone to the outer tube, and store the dies and samplers separately.
  • After cleaning is complete, keep the sampler in its respective case or wrap it in a clean polybag.
  • The dies shall be maintained  separately as per the size.
  • The cleaning activity of the sampling thieves shall be performed in the respective module (washing area) where the sampling thieves are used.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    Date Revision Number Reason for Revision
    – 00 New SOP

     

 

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