- 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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