STANDARD OPERATING PROCEDURE (SOP)

1.0 OBJECTIVE

To establish a standard procedure for cleaning the capsule filling line to ensure product quality, prevent cross-contamination, and comply with regulatory requirements.

2.0 SCOPE

This SOP applies to all capsule filling machines and associated equipment (e.g., dust extractors, capsule polishers, conveyors) used in the production department.

3.0 RESPONSIBILITY

• Machine Operators: Responsible for cleaning the capsule filling line as per this SOP.

• Production Supervisor: To ensure proper execution and documentation of cleaning.

• Quality Assurance: To verify and approve the cleaning process.

4.0 MATERIALS AND EQUIPMENT REQUIRED

• Lint-free cloths

• Nylon brushes

• Vacuum cleaner (if applicable)

• Purified water

• Approved detergent solution

• 70% Isopropyl Alcohol (IPA)

• Cleaning tags/labels

• Personal Protective Equipment (PPE)

5.0 PROCEDURE

5.1 Precautions

• Ensure the machine is turned OFF and de-energized before cleaning.

• Wear appropriate PPE before starting the cleaning activity.

• Cover nearby equipment or materials that should not be exposed during cleaning.

5.2 Type of Cleaning

• Product Changeover Cleaning (Major Cleaning)

• Batch-to-Batch Cleaning (Minor Cleaning)

• Periodic Cleaning (As per schedule or after maintenance)

5.3 Disassembly

1. Dismantle the following machine parts:

   • Hopper

   • Dosing disk

   • Tamping pins

   • Capsule feeding unit

   • Output chute

   • Dust extraction and polishing units

2. Transfer parts to the designated washing area.

5.4 Cleaning Process

5.4.1 For Removable Parts:

1. Dry brush to remove powder residue.

2. Wash with warm purified water and detergent solution.

3. Rinse thoroughly with purified water.

4. Wipe with a lint-free cloth or air dry in a clean area.

5. Sanitize with 70% IPA if required.

5.4.2 For Fixed Parts (Machine Body):

1. Wipe all accessible surfaces with lint-free cloth soaked in purified water.

2. Use 70% IPA to sanitize contact surfaces.

3. Avoid direct application of water on electrical components.

5.5 Reassembly and Post-Cleaning

1. Ensure all parts are completely dry before reassembly.

2. Reassemble all components correctly.

3. Inspect visually for cleanliness.

4. Affix a “Cleaned” status label with date and initials.

5. Record the activity in the Equipment Cleaning Logbook.

6.0 CLEANING FREQUENCY

• After each batch (as per product type)

• During product changeover

• After maintenance or any contamination event

• As per approved cleaning validation protocols

7.0 RECORDS AND DOCUMENTATION

• Equipment Cleaning Logbook

• Cleaning Checklist

• QA Cleaning Verification Record

• Line Clearance Record (if applicable)

8.0 ABBREVIATIONS

• SOP: Standard Operating Procedure

• IPA: Isopropyl Alcohol

• PPE: Personal Protective Equipment

• GMP: Good Manufacturing Practice

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