Standard Operating Procedure (SOP)

 This SOP ensures the cubicle remains clean, compliant with GMP standards, and ready for subsequent production batches.

1. Objective:

To lay down the procedure for the proper cleaning of the capsule filling cubicle to prevent cross-contamination and maintain hygiene and GMP compliance.

2. Scope:

This SOP applies to all capsule filling cubicles used in the production department of [Company Name].

3. Responsibility:

• Production Operator/Assistant: Perform cleaning.

• Production Officer/Executive: Verify and record cleaning.

• QA Officer: Audit and approve cleaning before the next batch starts.

4. Materials Required:

• Clean lint-free cloths

• Approved disinfectant solution (e.g., IPA 70%)

• Vacuum cleaner (GMP compliant)

• Detergent solution (if applicable)

• Cleaning checklist logbook

• Personal Protective Equipment (PPE)

5. Procedure:

5.1 Pre-Cleaning Checks:

1. Ensure the machine is switched off and power supply disconnected.

2. Display “Cleaning in Progress” signage.

3. Wear appropriate PPE (gloves, mask, cap, shoe covers, etc.).

4. Remove all previous batch records, raw materials, and tools from the cubicle.

5.2 Cleaning Procedure:

1. Dry Cleaning (if applicable):

   • Use a vacuum cleaner to remove dust from all surfaces including walls, floor, and ceiling.

   • Vacuum machine parts and surrounding work surfaces.

2. Wet Cleaning:

   • Prepare an approved cleaning solution (detergent and/or disinfectant).

   • Wipe down all interior surfaces including walls, windows, doors, lights, and machine exteriors using lint-free cloths.

   • Pay special attention to corners and joints where dust can accumulate.

   • Clean the floor using a mop and disinfectant solution.

3. Cleaning Equipment:

   • Clean capsule filling equipment parts as per equipment-specific SOP.

   • Ensure all dismantled parts are cleaned and dried before reassembly.

4. Waste Disposal:

   • Dispose of used cloths, gloves, and waste material in designated bins.

   • Record disposal as per waste handling SOP.

5.3 Post-Cleaning Activities:

1. Inspect all surfaces for cleanliness.

2. Replace “Cleaning in Progress” signage with “Cleaned & Ready for Use” after QA verification.

3. Record cleaning details in the cleaning logbook (date, time, person, signature).

4. Allow QA to inspect and sign off before starting the next operation.

6. Documentation:

• Cleaning Logbook

• QA Inspection Report

• Cleaning Checklist

7. Frequency:

• After every batch

• At the end of the day

• Whenever a product changeover occurs

8. Precautions:

• Do not use unapproved cleaning agents.

• Ensure no cleaning residue is left behind.

• Use only GMP-grade equipment and materials.

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