Cleaning of Unit Dose and Large Volume Sampling Thieves

• 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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