Standard Operating Procedure (SOP)

1.0 OBJECTIVE

To establish a procedure for the proper cleaning and sanitation of bins and HDPE containers used in the production process to prevent contamination, ensure product quality, and maintain compliance with GMP standards.

2.0 SCOPE

This SOP applies to all bins and HDPE (High-Density Polyethylene) containers used in the production, packaging, or storage areas of [Company Name]. It covers the cleaning of both empty and filled containers before reuse in production.

3.0 RESPONSIBILITY

• Production Operators: Responsible for cleaning and sanitizing bins and HDPE containers following the SOP.

• Production Supervisor: Ensures cleaning procedures are followed and verifies cleanliness.

• Maintenance Personnel: Responsible for the repair and maintenance of cleaning equipment if required.

• Quality Assurance (QA): Verifies that all cleaned bins and containers meet hygiene and safety standards.

4.0 MATERIALS AND EQUIPMENT REQUIRED

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

• Soft brushes

• Lint-free cloths

• Detergent (approved, non-corrosive, suitable for HDPE)

• 70% Isopropyl Alcohol (IPA) or approved sanitizer

• Hot water

• Water supply (clean, potable)

• Rinsing station (or designated washing area)

• Drying rack or clean drying area

• Cleaning logbook/form

• “Cleaned” or “To Be Cleaned” tags

• Bucket or wash basin

• Pressure washer (optional)

5.0 PROCEDURE

5.1 Pre-Cleaning Preparation

1. Wear PPE: Ensure that operators wear appropriate PPE, including gloves, gown, mask, and goggles, before starting the cleaning process.

2. Disassemble Containers: If applicable, remove any lids, covers, or accessories attached to the bins or containers.

3. Inspection: Inspect the bins and HDPE containers for visible contamination, dirt, or residue. Record any significant damage in the logbook.

5.2 Dry Cleaning (Initial Cleaning)

1. Remove Residues: Use a soft brush to remove any dry residues, powders, or particles from the surface of the bins or containers.

2. Empty Bins: Ensure that any leftover material in the containers is removed before moving to the wet cleaning phase.

3. Use Compressed Air (Optional): If possible, use compressed air to blow out any trapped dust or residues, especially from hard-to-reach areas.

5.3 Wet Cleaning

1. Prepare Cleaning Solution: Prepare a solution of approved detergent and warm water. Use a concentration that is suitable for cleaning HDPE containers without causing damage.

2. Cleaning the Containers:

   • Immerse the bins and containers in the cleaning solution or apply the solution using a clean cloth or sponge.

   • Scrub the interior and exterior surfaces of the bins and containers to remove any residual product buildup, dirt, or grime.

   • For stubborn residues, use a soft brush to scrub and remove material.

3. Rinse Thoroughly: Rinse the bins and containers thoroughly with clean potable water to remove all detergent residues.

5.4 Sanitization (Optional but Recommended)

1. Sanitize the Containers: If required, apply a 70% IPA or another suitable sanitizer to sanitize the interior and exterior surfaces of the bins and containers.

2. Allow to Air Dry: Allow the sanitizer to remain on the surface for the required contact time (as per sanitizing protocol) and allow the bins and containers to air dry.

3. Rinse Off Excess Sanitizer (if required): If necessary, rinse off any excess sanitizer or allow it to evaporate.

5.5 Drying

1. Dry the Containers:

   • Place the cleaned bins and containers on a clean drying rack in a designated clean area.

   • Ensure that the containers are fully dry before reassembling or reusing them.

5.6 Post-Cleaning Inspection

1. Inspection:

   • Inspect each cleaned bin and HDPE container to ensure it is free from cleaning residues, dust, and moisture.

   • Check for any physical damage to the containers (e.g., cracks, wear).

2. Tagging: Attach a “Cleaned” tag to the bins and containers with the date, time, and initials of the operator who cleaned the container.

3. Record in Logbook: Document the cleaning activity in the cleaning logbook/form, noting any issues, observations, or repairs needed.

5.7 Reassembly and Storage

1. Reassemble Containers: If any parts (e.g., lids, covers) were removed, reassemble them after cleaning and drying.

2. Storage: Store the cleaned bins and HDPE containers in a designated clean area to avoid contamination before reuse.

6.0 CLEANING FREQUENCY

• After every product batch or shift change

• After product changeover

• Before and after any major maintenance activities

• As per the cleaning schedule defined by cleaning validation protocols

7.0 RECORDS AND DOCUMENTATION

• Cleaning Logbook

• Inspection Reports

• Cleaning Checklist

• Maintenance Records (if applicable)

8.0 ABBREVIATIONS

• SOP: Standard Operating Procedure

• IPA: Isopropyl Alcohol

• PPE: Personal Protective Equipment

• GMP: Good Manufacturing Practice

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