Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for the Cleaning of Automatic Coating System, used primarily for film/sugar coating of tablets in pharmaceutical manufacturing.

1. Objective

To lay down the procedure for cleaning the Automatic Coating System to maintain hygiene, prevent cross-contamination, and ensure GMP compliance.

2. Scope

Applicable to all Automatic Coating Systems used in the pharmaceutical manufacturing department for tablet coating.

3. Responsibility

• Machine Operator: To perform cleaning as per SOP.

• Production Supervisor: To verify and ensure cleaning is performed correctly.

• Quality Assurance (QA): To inspect and approve the cleaned equipment before reuse.

4. Materials Required

• Purified Water

• Approved Detergent or Cleaning Agent

• Lint-free cloths or wipes

• Soft nylon brush

• Disinfectant (if applicable)

• PPE (gloves, goggles, mask, apron)

• Cleaning logbook or checklist

5. Procedure

5.1 Pre-Cleaning

1. Ensure that the coating process is completed and the machine is switched off.

2. Disconnect the power supply.

3. Display a “Under Cleaning” status label.

4. Wear appropriate PPE before starting the cleaning.

5.2 Cleaning Procedure

A. Product Contact Parts:

1. Open the coating pan and remove any visible residues (e.g., coating solution, tablets).

2. Use a dry cloth or vacuum to remove loose powder.

3. Clean the pan interior, baffles, spray guns, solution pipes, and exhaust ducts with a detergent solution using a soft brush.

4. Rinse thoroughly with purified water to remove detergent residues.

5. For water-sensitive components, clean with 70% IPA if applicable.

B. Spray Guns and Peristaltic Pump:

1. Remove spray guns and solution delivery tubes.

2. Flush with purified water or suitable solvent to remove coating residues.

3. Disassemble, clean, rinse, and dry thoroughly before reassembling.

C. Air Handling & Exhaust Ducts:

1. Wipe external air filters and accessible internal duct areas.

2. Clean exhaust vents using a brush and vacuum if necessary.

D. Non-Product Contact Parts:

1. Wipe machine exterior, control panels, and non-contact areas with a damp cloth and approved disinfectant.

5.3 Post-Cleaning

1. Dry all components using lint-free cloth or compressed air.

2. Reassemble all parts carefully.

3. Affix a “Cleaned” status label with the date, time, and signature.

4. Record the cleaning in the logbook.

5. Submit the equipment for QA inspection.

6. Precautions

• Do not use abrasive tools that may scratch coated surfaces.

• Avoid direct contact of electrical parts with water.

• Ensure all parts are thoroughly dry before reassembly.

• Use only approved cleaning agents.

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