Standard Operating Procedure (SOP)

1.0 OBJECTIVE

To lay down a procedure for cleaning the Deblistering Machine to ensure equipment cleanliness, avoid cross-contamination, and maintain GMP compliance.

2.0 SCOPE

This procedure applies to all personnel involved in the cleaning of the Deblistering Machine used in the [Packaging / Production] department.

3.0 RESPONSIBILITY

• Operators: Responsible for proper cleaning as per SOP.

• Production Supervisor: To ensure SOP compliance and maintain cleaning records.

• QA Department: To verify cleanliness and release the equipment for use.

4.0 MATERIALS AND EQUIPMENT

• Lint-free cloths

• Clean potable water

• 70% IPA (Isopropyl Alcohol)

• Nylon brush

• Vacuum cleaner (if applicable)

• Cleaning tags/labels

• PPE (gloves, mask, gown, goggles)

5.0 PROCEDURE

5.1 Pre-Cleaning

1. Switch OFF the machine and disconnect from the power supply.

2. Remove all product remnants, blister packs, and waste material.

3. Put on appropriate PPE.

5.2 Disassembly

1. Dismantle all removable parts: rollers, feed trays, product collection trays, etc.

2. Transfer parts to the designated cleaning area (if applicable).

5.3 Cleaning of Parts

1. Dry brush all parts to remove loose powder and debris.

2. Clean with potable water and mild detergent, using a nylon brush if needed.

3. Rinse thoroughly with clean water to remove detergent.

4. Wipe dry with a lint-free cloth or allow to air dry.

5. Sanitize using 70% IPA and allow to dry.

5.4 Cleaning of Main Machine Body

1. Wipe external and internal surfaces with a lint-free cloth dampened with potable water.

2. Use IPA to sanitize all contact surfaces.

3. Clean sensors and electrical parts with a dry lint-free cloth (do not use water or IPA directly).

5.5 Reassembly and Post-Cleaning

1. Reassemble the machine after all parts are completely dry.

2. Visually inspect for cleanliness.

3. Affix a “Cleaned” label with date and signature.

4. Enter cleaning details in the Equipment Cleaning Logbook.

6.0 FREQUENCY

• After every batch or product changeover

• After maintenance or repair

• As per validated cleaning frequency schedule

7.0 RECORDS

• Equipment Cleaning Logbook

• Cleaning Checklist/Form

• Line Clearance Record

8.0 ABBREVIATIONS

• SOP: Standard Operating Procedure

• IPA: Isopropyl Alcohol

• PPE: Personal Protective Equipment

• GMP: Good Manufacturing Practice

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