SOP on Cleaning of Sampling Aids
To lay down a procedure for cleaning Sampling Aids.
Officer – Quality Quality Assurance to implement the procedure.
Head – Quality Quality Assurance to ensure compliance.
Preparation of Detergent solution (2% Extran MA 02 Neutral, solution).
To about 980 mL of potable water in a plastic beaker add about 20ml of Extran and mix thoroughly.
Preparation of 70% Isopropyl alcohol:
About 300 mL of purified water add about 700ml of Isopropyl alcohol and mix thoroughly.
Procedure for Spoons & Funnels:
Scrub the spoons/funnels with a nylon brush using a detergent solution, until the visible stains, if any is removed.
Thoroughly wash with potable water to remove any residues of detergent.
Finally, rinse with purified water.
Dry the spoons/funnels in a hot air oven for about 1 hour and cool to room temperature.
After completion of drying, wrap the spoons/funnels in polybags and label as cleaned
sampling aids, and keep them in their respective drawers.
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 lint-free 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 stuck at the corners of the partitions in the inner tube using a nylon brush.
Thoroughly wash the inner and outer tubes with an ample amount of potable water to remove the detergent residues.
Rinse the inner and outer tubes with about a liter of Purified water.
Wipe dry the tubes with a clean lint-free cloth.
Wipe the tubes with 70 % Isopropyl alcohol solution, and allow them to dry preferably in a hot air oven.
Inspect visually for any residues, if any residues are observed repeat the cleaning.
After drying label them as cleaned sampling aids and keep them in their respective place.
Procedure for liquid samplers :
Dip the glass apparatus into the cleaning solution. Soak for about 1 hour in the cleaning solution and remove from it.
Take potable water up to half of its capacity and rinse by inverting and shaking several times and discard the solution. Rinse with potable water four more times.
Finally, rinse them with purified water two times and keep them in a tray allowing them to dry.
Procedure for Sampling bottles :
The sampling bottles and caps shall be soaked in potable water. take them out.
Shake several times by capping the bottles.
Rinse the bottles and caps twice with purified water.
Dry the cleaned bottles in a hot air oven at 105°C for about 1 hour.
Mop the caps with 70% IPA solution and allow them to dry keeping them separately in a tray.
Once cleaning is complete, cap the bottles and place them near the sampling station in the respective container labeled for the purpose.
Only unused bottles shall be used for sampling. Once used, the sampling bottles shall not be reused for sampling activity.
Only sterilized bottles shall be used for microbiology samples.
Microsampling shall be done prior to any other sampling.
Forms and Records (Annexures)
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control. engineering
For More Pharma Updates Visit –https://pharmaguidances.com