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SOP on Cleaning of Strip Pack Machine

1.0 OBJECTIVE: To lay down a procedure for cleaning of Strip Pack Machine.
2.0 SCOPE: This procedure is applicable to the cleaning of strip pack machine in the
3.0 RESPONSIBILITY: Operator, Officer, and Executive – Production Department
Manager – Production Department

4.0 PROCEDURE :
4.1 TYPE A Cleaning of Strip Pack Machine
Change over from one batch to the next batch of the same product and the same potency and of a similar product with ascending potency.
4.1.1 Ensure that all the materials of the previous batch are removed from the Strip pack cubicle.
4.1.2 Record the cleaning activity in the equipment usage log sheet.
4.1.3 Replace the ‘TO BE CLEANED’ status label with the ‘UNDER CLEANING’ status label with the date and sign of the production officer.
4.1.4 Clean the machine with a clean dry lint free duster and vacuum cleaner.
4.1.5 Clean the chute, hopper, and vibration plate and brush with a dry lint-free duster.
4.1.6 Clean the pressure sealing rollers with a brass brush to remove all the adhered material
4.1.7 Clean with the help of thinner.
4.1.8 Wipe the Batch coding unit with the duster dipped into thinner and remove the spread ink.
4.1.9 Clean the conveyor belt with a dry lint-free duster.
4.1.10 Replace the ‘UNDER CLEANING’ status label with the ‘CLEANED’ status label with the date and sign of the production officer.
4.1.11 Record the cleaning activity in the equipment usage log sheet.

Related: Operation of Strip Packing Machine

4.2 TYPE B Cleaning of Strip Pack Machine
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 Replace the ‘TO BE CLEANED’ status label with the ‘UNDER CLEANING’ status label with the date and a sign of the production officer.
4.2.2 Ensure that the power supply is put off.
4.2.3 Clean the machine and area with a vacuum cleaner.
4.2.4 Dismantle the feed hoppers, vibration plate, brush, and chute. Place them in a plastic bag and transfer them to the washing area.
4.2.5 Scrub the dismantled parts with a nylon scrubber using purified water.
4.2.6 Clean the dismantled parts with purified water.
4.2.7 Dry the cleaned parts with a dry lint-free cloth.
4.2.8 Wipe the cleaned dismantled parts with 70% v/v IPA solution.
4.2.9 Clean the pressure sealing rollers with a brass brush to remove all the powder and then clean with the help of a cleaning aid.
4.2.10 Wipe the batch-coding unit with a duster dipped in thinner to remove the spread ink and then clean with a dry lint-free cloth.
4.2.11 Keep all these cleaned parts in the storage cabinet of change parts for a strip
Pack machine in packing spare parts room.
4.2.12 Clean the surrounding area of the machine.
4.2.13 Take the changed parts as per product requirement and transfer them to the
strips pack machine area.
4.2.14 Assemble the pressure sealing rollers, feeding hopper, chute, brush, and Printing gears.
4.2.15 Clean the inner and outer surface of the machine, control panel, limit switches, exhaust fan, and utility lines with a dry lint-free cloth.
4.2.16 Wipe the machine with 70% v/v IPA solution.
4.2.17 Clean the conveyor belt and pass box with a dry lint-free duster.
4.2.18 Replace the ‘UNDER CLEANING’ status label with the ‘CLEANED’ status label with the date and signature of the production officer.
4.2.19 If the machine remains idle for more than 72 hours after cleaning, then replace a “CLEANED’ status label with the ‘TO BE CLEANED BEFORE USE” status label with the date and signature of the Production Officer.
4.2.20 Clean the machine with a dry lint-free duster followed by wiping it with 70% v/v IPA solution before using the machine.
4.2.21 Record the cleaning activity in the equipment usage log sheet as per “Making entries in equipment Logbook” SOP.

5.0 ABBREVIATION:
IPA: Iso Propyl Alcohol
Q.A.: Quality Assurance
SOP: Standard Operating Procedure
SS: Stainless Steel

    by
  • Naresh Bhakar
    (Author)

    Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has exprience in Pharma manufactring and worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don't hesitate to reach out via email at [email protected].

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