Standard Operating Procedure (SOP)

1. Purpose

This SOP describes the procedure for the proper cleaning of the dissolution tester to prevent cross-contamination, ensure equipment integrity, and maintain accuracy in dissolution testing.

2. Scope

This procedure applies to all dissolution testers used in [Laboratory/Department Name] for product testing.

3. Responsibilities

• Analysts: Clean the dissolution tester as per this SOP after each use.

• Supervisors/Managers: Verify cleaning completion and compliance with SOP.

• QA Personnel: Audit cleaning records and ensure adherence.

4. Materials and Equipment

• Purified Water (or Distilled Water)

• Mild Laboratory-Grade Detergent (non-abrasive, non-corrosive)

• Soft Lint-Free Cloths

• Cleaning Brushes (non-metallic)

• Disposable Gloves

• Labeled Waste Containers

• Clean Dry Towels

• Alcohol (optional for final wipe down)

5. Procedure

5.1 General Precautions

• Always disconnect the instrument from the power source before cleaning.

• Wear appropriate PPE (gloves, lab coat, goggles).

• Never use harsh chemicals, abrasives, or metal brushes on the equipment.

5.2 Cleaning After Each Use

1. Disassembly:

   • Remove and dismantle the paddles/baskets and shafts carefully.

   • Remove vessels from the tester.

2. Cleaning:

   • Rinse all removable parts (vessels, paddles, baskets) with purified water immediately after use.

   • Use a soft brush and mild detergent to clean surfaces if residues are present.

   • Rinse thoroughly with purified water to remove all detergent traces.

   • Wipe down the external surfaces of the tester with a soft, damp cloth.

3. Drying:

   • Allow all cleaned parts to air dry on a clean surface.

   • Alternatively, dry with clean, lint-free towels.

4. Reassembly and Storage:

   • Reassemble clean, dry parts or store them in a clean, covered area if not immediately reused.

   • Ensure vessels and paddles/baskets are stored upside down to prevent contamination.

5.3 Weekly or Deep Cleaning (or After Stubborn Contamination)

• Perform thorough cleaning of the entire tester, including:

  • Drive unit

  • Shaft holder and vessel holders

  • Vessel platform and water bath

• Empty and clean the water bath if applicable (especially if algae, mold, or deposits are observed).

• Inspect and clean sensors, if equipped.

5.4 Cleaning Validation (if required)

• If cleaning validation is part of your protocol (e.g., GMP environment), swab test critical parts post-cleaning to confirm absence of residues.

6. Documentation

• Record all cleaning activities in the Cleaning Logbook.

• Include:

  • Date and time

  • Name/ID of person cleaning

  • Equipment ID number

  • Notes on any observed abnormalities (e.g., damage, residue)

  • Supervisor’s verification signature (if required)

7. Acceptance Criteria

• No visible residue or contamination on any part of the dissolution tester.

• No water spots or detergent residues left after drying.

• Equipment ready for next use or storage.

8. Precautions

• Do not immerse motorized or electronic parts in water.

• Handle fragile parts (like vessels) with care to avoid breakage.

• Use only approved detergents and materials specified for laboratory use.

9. References

• USP <711> Dissolution

• Internal Laboratory Cleaning Guidelines

• Equipment Manufacturer’s Manual.

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