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SOP for Cleaning of Strip Pack Machine

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Strip Pack Machine is used to pack tablets or capsules in a pharmaceutical company

1.0 Objective: To establish a process for cleaning the Strip Pack Machine.

2.0 Scope: This procedure applies to the cleaning of the strip pack machine within the production department.

3.0 Responsibility: Operators, Officers, and Executives in the Production Department are responsible for this procedure.
The Production Department Manager is responsible for overall compliance with this SOP.

4.0 Definitions: None applicable.

SOP for Cleaning of Strip Pack Machine

5.0 Procedure:
5.1 Type A

  • Transitioning from one batch to the next batch of the same product and potency or a similar product with increasing potency.
  • Ensure the removal of all materials from the previous batch within the Strip Pack Cubicle.
  • Document the cleaning activity in the equipment usage log sheet.
  • Replace the ‘TO BE CLEANED’ label with the ‘UNDER CLEANING’ label, indicating the date and the signature of the production officer.
  • Employ a clean, dry, lint-free duster and a vacuum cleaner for machine cleaning.
  • Thoroughly clean the chute, hopper, vibration plate, and brush using a dry, lint-free duster.
  • Employ a brass brush to meticulously clean the pressure sealing rollers, eliminating any adhered material.
  • Utilize a cleaning agent, such as thinner, for cleaning.
  • Employ a duster soaked in thinner to wipe the Batch Coding Unit, removing spread ink.
  • Ensure the conveyor belt is cleaned using a dry, lint-free duster.
  • Replace the ‘UNDER CLEANING’ label with the ‘CLEANED’ label, including the date and the signature of the production officer.
  • Document the cleaning activity in the equipment usage log sheet.

5.2 Type B

  • This procedure involves cleaning when switching to a product with different properties, colors, decreasing potency, or after maintenance of contact parts.
  • Replace the ‘TO BE CLEANED’ label with the ‘UNDER CLEANING’ label, indicating the date and the signature of the production officer.
  • Ensure the power supply is turned off.
  • Utilize a vacuum cleaner to clean both the machine and its surroundings.
  • Disassemble the feed hoppers, vibration plate, brush, and chute. Place these components in a plastic bag and move them to the washing area.
  • Scrub the disassembled parts using purified water and a nylon scrubber.
  • Rinse the disassembled parts with purified water.
  • Dry the cleaned parts using a dry, lint-free cloth.
  • Wipe the cleaned disassembled parts with a 70% v/v IPA solution.
  • Clean the pressure sealing rollers using a brass brush to eliminate all traces of powder, followed by cleaning with a cleaning aid.
  • Clean the Batch-Coding Unit by wiping it with a duster dipped in thinner to remove spread ink, then use a dry, lint-free cloth.
  • Store the cleaned parts in the change parts storage cabinet for the strip pack machine in the spare parts room.
  • Clean the machine’s surrounding area following SOP No. PRD/048.
  • Select the required change parts according to the product and transfer them to the strip pack machine area.
  • Assemble the pressure sealing rollers, feeding hopper, chute, brush, and printing gears.
  • Wipe the machine’s inner and outer surfaces, control panel, limit switches, exhaust fan, and utility lines with a dry, lint-free cloth.
  • Clean the machine with a 70% v/v IPA solution.
  • Clean the conveyor belt and pass box using a dry, lint-free duster.
  • Follow SOP to “clean the area”.
  • Replace the ‘UNDER CLEANING’ label with the ‘CLEANED’ label, indicating the date and the signature of the production officer.
  • If the machine remains unused for over 72 hours after cleaning, replace the ‘CLEANED’ label with the ‘TO BE CLEANED BEFORE USE’ label, including the date and the signature of the Production Officer.
  • Clean the machine using a dry, lint-free duster followed by wiping with a 70% v/v IPA solution before using it.
  • Document the cleaning activity in the equipment usage log sheet, referencing SOP.

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

7.0 References:
SOP: Cleaning of production area.
SOP: Making entries in equipment usage and cleaning log sheet.

Related SOP: SOP on Procedure for the Blister Pack Machine

8.0 Annexures:
None available.

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