Cleaning of Unit Dose and Large Volume Sampling Thieves
OBJECTIVE :
To lay down the procedure for cleaning 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 a plastic beaker add about 20 mL of Extran and mix thoroughly.
Preparation of 70% Isopropyl 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 the 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 an ample amount of potable water to remove detergent residue.
Rinse the inner and outer tubes with about a liter 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 are 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 the 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 an ample amount of potable water to remove detergent residue.
Rinse the inner and outer tubes with about a liter of Purified water.
Wipe dry the tubes, dies, and end cone with a clean cloth.
Rinse the tubes, dies and end cone 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 are 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
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