Home » Pharma SOPs » Production SOPs » SOP on Cleaning of Coating Solution Preparation Tank

SOP on Cleaning of Coating Solution Preparation Tank

1.0 OBJECTIVE: To lay down a procedure for cleaning of coating solution preparation tank.

2.0 SCOPE: This SOP is applicable to the cleaning of the coating solution preparation tank in the production department.

3.0 RESPONSIBILITY:
Operator responsible for cleaning Officer, and Executive – Production Department to ensure activity as per given procedure
Manager – Production Department for compliance with this procedure

4.0 PROCEDURE:
4.1 TYPE A: Change over from one batch to the next batch of the same product and same potency and of similar product with ascending potency.
4.1.1 Replace the ‘TO BE CLEANED’ status label with a duly filled and signed ‘UNDER CLEANING’ status label.
4.1.2 Ensure that the main power supply is turned ‘OFF’.
4.1.3 Wipe the equipment with a dry lint-free cloth.
4.1.4 Replace the ‘UNDER CLEANING’ status label with a duly filled and signed ‘CLEANED’ status label.
4.2 TYPE B: This is a cleaning procedure for Change over of product with different actives/color / descending potency or after the maintenance of contact parts.
4.2.1 Follow the procedure from step no. 4.1.1 to 4.1.3.
4.2.2 Dismantle the stirrer from the main shaft.
4.2.3 Take the stirrer and top lid into the coating wash area.
4.2.4 Rinse the stirrer and top lid with purified water.
4.2.5 Scrub the stirrer and top lid with a nylon brush till all the adhered residues of the previous product get softened. Use IPA 70 % v/v in case adhered material does not scrub out.
4.2.6 Flush enough purified water till all the visible residues of the previous product are washed away.
4.2.7 Cover the stirrer motor with a double polybag.
4.2.8 Clean the area as per SOP “Cleaning and sanitization in pharmaceuticals“.
4.2.9 Rinse the inner surface of the coating solution preparation tank with purified water.
4.2.10 Scrub the inner surface with a nylon brush till all the adhered residues of the previous product get softened. Use IPA 70 % v/v in case adhered material does not scrub out.
4.2.11 Flush enough purified water till all the visible residues of the previous product are washed away.
4.2.12 Wipe the outer surface of the coating solution preparation tank with a wet lint-free cloth.
4.2.13 Wipe the inner and outer surface of the coating solution preparation tank with a dry clean lint-free cloth.
4.2.14 Spray 70 % IPA v/v on the inner surface of the coating solution preparation tank.
4.2.15 Wipe the outer surface with 70 % IPA v/v with a clean lint-free cloth.
4.2.16 Bring the cleaned stirrer and top lid from the coating washing area and wipe with 70 % IPA v/v with a clean lint-free cloth.
4.2.17 Affix dully filled and signed the ‘CLEANED’ label on the equipment.
4.2.18 If the equipment is idle then replace the ‘CLEANED’ status label with the ‘TO BE CLEANED’ status label.
4.2.19 Re-clean by treating with 70 % v/v IPA solution before use by the following step no.
4.2.20 Replace the ‘TO BE CLEANED’ status label with the ‘CLEANED’ status label.
4.2.21 Record the cleaning observations in the Equipment usage log sheet as per the given SOP.
4.4 Frequency
4.4.1 Type ‘A’ cleaning is applicable after the completion of every batch of the same product.
4.4.2 Type ‘B’ cleaning is applicable in case of product change over or the same product.
4.5 Precaution
4.5.1 After completion of the operation, clean the equipment before use.

Read Also: SOP on the Operation of Auto Coater.

5.0 ABBREVIATION(S):
IPA: Iso Propyl Alcohol
SOP: Standard Operating Procedure
v/v: Volume by Volume

Leave a Comment

Share via
Copy link
Powered by Social Snap