SOP for Cleaning of Automatic Coating System : Pharmaguideline

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SOP for Cleaning of Automatic Coating System

Standard operating procedure to clean the Automatic Coating System.

1.0 OBJECTIVE:

To lay down the cleaning procedure for Automatic Coating System..

2.0 SCOPE:

This SCP shall be applicable for Automatic Coating System 36”, 48” & 60” in Coating area in Production department.

3.0 RESPONSIBILITY:

3.1 Execution :Operator
3.2 Checking :Pharmacist and Above

4.0 ACCOUNTABILITY:

HOD-Production

5.0 PROCEDURE:

5.1 Close the Outlet Drainage Valve.
5.2 Fit the cleaning bar with nozzles to the spray bar.
5.3 Start pan rotation.
5.4 Open the Potable water supply valve and switch “ON” the washing pump. Ensure that Potable water is coming through nozzles.
5.5 Continue pan rotation for about 15 minutes.
5.6 Stop the pan rotation and the washing pump.
5.7 In case of cleaning after enteric coating, Add approximate 15 lit of 20 %w/v NaOH solution in coating pan and rotate for 10 to 15 minutes. Drain out the alkaline solution from the pan and clean the pan with Potable water & then 2.5 % “Teepol” solution.
5.8 Close the Potable water supply valve.
5.9 If any coating patches remain in coating pan remove them with the help of the scrubber and finally rinse the pan with 100 liter purified water.
5.10 Detach the cleaning bar and Close the front door.
5.11 Start the exhaust blower and the hot air blower for 10 to 15 minutes & allow drying.

5.12 Wipe with 70% v/v solution of Isopropyl Alcohol (IPA).
5.13 Affix the ‘Cleaned’ label and fill the “Equipment Log Book”.
5.14 Re-cleaned if not used within 72 hours.

6.0 ABBREVIATIONS:

SCP :Standard Cleaning Procedure
IPA :Isopropyl Alcohol
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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  1. very nice ,may i ask the cleaning procedure of coating machine after coating with Eudragit-E 100 a synthetic polymer, because we are facing a lot of problem and time taking cleaning procedure. please guide us in this mattter thanks

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