Standard Operating Procedure (SOP)

1.0 OBJECTIVE

To establish a standardized procedure for the cleaning of metal detectors to ensure proper operation, prevent contamination, and maintain compliance with GMP requirements.

2.0 SCOPE

This SOP applies to all metal detectors used in the production and packaging areas for inspecting products to detect metal contaminants.

3.0 RESPONSIBILITY

• Production Operators: Responsible for cleaning the metal detector as per the SOP.

• Production Supervisor: To ensure cleaning is done correctly and documentation is maintained.

• Quality Assurance (QA): To verify that the metal detector is clean and operational after cleaning.

4.0 MATERIALS AND EQUIPMENT REQUIRED

• Lint-free cloths

• Soft brushes (non-abrasive)

• Purified water

• 70% Isopropyl Alcohol (IPA) or approved sanitizer

• Vacuum cleaner (optional, depending on the setup)

• Soft sponge or microfiber cloth

• PPE (Personal Protective Equipment): gloves, mask, gown, goggles

• Cleaning logbook/form

• “Cleaned” status tags

5.0 PROCEDURE

5.1 Pre-Cleaning Preparation

1. Power Off: Ensure the metal detector is turned off and disconnected from the power supply (if necessary).

2. Safety First: Wear appropriate PPE (gloves, mask, gown, and goggles).

3. Status Labeling: Tag the metal detector with a “To Be Cleaned” label.

4. Remove Product: Ensure no product is running through the machine during cleaning.

5.2 Dry Cleaning

1. Initial Inspection: Visually inspect the metal detector for any visible dirt, debris, or product buildup.

2. Remove Debris: Use a soft brush to remove dust and debris from the detector, conveyor, and surrounding areas. If needed, use a vacuum cleaner to remove any excess material.

3. Check for Metal Residue: If metal particles are present, use a lint-free cloth to wipe surfaces.

5.3 Wet Cleaning

1. Prepare Cleaning Solution: Dampen a lint-free cloth or sponge with purified water or 70% IPA. Ensure the cloth is not overly wet to avoid water ingress into electrical components.

2. Wipe Surfaces: Carefully wipe the external surfaces of the metal detector, including the conveyor belt, casing, and metal detector probe. Do not apply water or cleaning solution directly to the probe.

3. Sanitization (Optional): If necessary, use 70% IPA or another approved sanitizer to sanitize the surfaces.

5.4 Probe Area Cleaning

1. Dry Wipe Only: Clean the probe area gently with a dry, soft cloth to avoid introducing moisture into the probe system.

2. Use a Brush: If there is any buildup on the probe, use a soft brush to clean it. Ensure no foreign material enters the probe during cleaning.

3. Do Not Disassemble: Do not attempt to disassemble the probe or metal detector unit unless specified by the manufacturer’s guidelines.

5.5 Post-Cleaning Steps

1. Drying: Allow all cleaned surfaces to dry fully before operating the metal detector. If needed, use a dry, lint-free cloth to absorb any excess moisture.

2. Reassembly: If any parts were removed (e.g., conveyor belt), reassemble them according to manufacturer specifications.

3. Inspection: Perform a visual inspection to ensure all components are free from cleaning residues and debris.

4. Check Functionality: Ensure that the metal detector’s sensitivity is not impacted by the cleaning process. It may require a test run with a metal sample to verify its functionality.

5.6 Documentation and Labeling

1. Cleaned Label: Attach a “Cleaned” status label with the operator’s initials, cleaning date, and time.

2. Cleaning Log: Record all cleaning activities, including details of the cleaning process and any issues encountered, in the Cleaning Logbook.

6.0 CLEANING FREQUENCY

• After every product batch or shift change

• During or after any product changeover

• When switching between different product types

• Periodically, as defined by the equipment’s cleaning validation schedule

7.0 RECORDS TO BE MAINTAINED

• Cleaning Logbook

• Metal Detector Maintenance Records

• Equipment Cleaning and Inspection Checklist

8.0 ABBREVIATIONS

• SOP: Standard Operating Procedure

• IPA: Isopropyl Alcohol

• PPE: Personal Protective Equipment

• QA: Quality Assurance

• GMP: Good Manufacturing Practice

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