SOP for Cleaning of Paste Kettle 100 liter (Bectochem)

In this post Standard Operating Procedure of SOP for Cleaning of Paste Kettle 100 liter (Bectochem) in Pharmaceuticals is describe.

1.0 OBJECTIVE:

To lay down a procedure for cleaning of Paste Kettle 100 litre (Bectochem).

2.0 SCOPE:

This SOP is applicable to the cleaning of Paste Kettle 100 litre (Bectochem) located in granulation area.

3.0 RESPONSIBILITY:

Production: Technical Associate/Officer /Executive/Assistant Manager

Head Production: To ensure execution & compliance.

Head QA: To ensure the compliance.

4.0 PROCEDURE:

4.1 This is a cleaning procedure for Change over of one batch to next batch / product with ascending potency, product with different actives / color / descending potency or after maintenance of contact parts.

4.1.1 Replace the ‘TO BE CLEANED’ status label with ‘UNDER CLEANING’ status label on paste preparation kettle with date and signature of the Production Officer.

4.1.2 Remove the detachable portion of the lid.

4.1.3 Charge approx. 40 to 50 kg of purified water into the kettle and warm the water by opening the steam inlet valve and soak for 15 minutes.

4.1.4 Tilt the kettle by rotating the wheel provided at the right side of the kettle and drain the purified water.

4.1.5 Scrub the inside, outside of kettle and lid of kettle with nylon scrubber to remove the adhered material.

4.1.6 Place the kettle to the original position by rotating Wheel.

4.1.7 Clean the inside, outside of kettle, lid of kettle and stirrer with approx. 40.0 to 50.0 kg purified water.

4.1.8 Dry the kettle with the help of clean dry lint free cloth.

4.1.9 Wipe all the parts of kettle with clean dry lint free cloth soaked in 70% v/v IPA solution.

4.1.10 Fix the stirrer and set the lid over the kettle.

4.1.11 Replace ‘UNDER CLEANING’ status label with “CLEANED” with date and signature of the Production Officer.

4.1.12 Record the cleaning time in equipment sequential log book as per SOP.

5.0 ANNEXURE (S):