Standard Operating Procedure (SOP)

Here’s a detailed Standard Operating Procedure (SOP) for the Cleaning of Three-Piece Filling Machine Parts and Silicon Tubing, commonly used in sterile and non-sterile pharmaceutical production environments for liquids or suspensions.

1.0 Objective

To lay down a procedure for proper cleaning, drying, and storage of the three-piece filling machine parts and silicon tubing to prevent contamination and ensure product quality.

2.0 Scope

This SOP is applicable to all detachable parts and silicon tubing of the three-piece filling machine used for filling liquids or suspensions in [Company Name].

3.0 Responsibility

4.0 Definitions

• Three-Piece Filling Machine: A semi-automatic or automatic machine used for filling liquid formulations.

• Silicon Tubing: Flexible, pharmaceutical-grade tubing used to transfer product during filling.

5.0 Materials Required

• Purified Water (PW)

• Hot Water (if applicable)

• 2% non-ionic cleaning solution (e.g., Teepol or equivalent)

• Lint-free cloth or sterile wipes

• Cleaning brushes of appropriate size

• Stainless steel trays for parts

• Labeling tags (Cleaned/To Be Cleaned)

• PPE (gloves, mask, apron, goggles)

6.0 Procedure

6.1 Pre-Cleaning Steps

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

2. Dismantle all product-contact parts:

   • Filling nozzles

   • Pistons and cylinders

   • Valves and connectors

   • Silicon tubing

3. Visually inspect parts for product residues.

6.2 Cleaning of Machine Parts

1. Rinse all parts with lukewarm purified water to remove residues.

2. Soak parts in 2% cleaning solution for at least 15 minutes.

3. Scrub all internal and external surfaces using designated brushes.

4. Rinse thoroughly with purified water until no foam or residue remains.

5. Perform a final rinse with hot purified water (if applicable).

6. Allow parts to air-dry in a clean and controlled environment, or use compressed air filtered through 0.2-micron filter.

6.3 Cleaning of Silicon Tubing

1. Rinse internal surface of tubing with purified water.

2. Circulate 2% cleaning solution through tubing using a peristaltic pump (if available) for 10–15 minutes.

3. Flush tubing with purified water until free from foam and cleaner.

4. Perform final rinse with hot purified water.

5. Dry using filtered compressed air or hang in drying cabinet.

6. Inspect tubing for cracks, discoloration, or kinks. Reject if damaged.

6.4 Post-Cleaning Activities

1. Visually inspect all parts and tubing.

2. Wipe external surfaces with lint-free cloth.

3. Place cleaned items in labeled stainless steel trays.

4. Affix “Cleaned” tag with:

   • Date of cleaning

   • Name/signature of operator and verifier

5. Store in designated clean area until use.

7.0 Cleaning Frequency

• After each batch or product changeover

• After prolonged shutdown (as per cleaning validation)

• Before maintenance or replacement

8.0 Precautions

• Use PPE at all times during cleaning.

• Avoid bending or overstretching the silicon tubing.

• Never reuse cleaning solutions.

• Ensure all parts are completely dry before storage or reassembly.

9.0 Documentation

• Cleaning Logbook (with date, part name, cleaned by, checked by)

• Cleaning Checklist for each part

• Deviation Report (if any abnormality is observed)

10.0 Abbreviations

• SOP: Standard Operating Procedure

• PW: Purified Water

• QA: Quality Assurance

• PPE: Personal Protective Equipment

11.0 Annexures

• Annexure 1: Cleaning Checklist

• Annexure 2: Cleaning Log Format

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