1.0 Purpose

To describe the procedure for proper cleaning, maintenance, and storage of sampling equipment used for raw materials, intermediates, and finished products to avoid contamination, cross-contamination, and ensure equipment integrity.

2.0 Scope

This SOP applies to all types of sampling equipment (e.g., stainless steel sampling thieves, scoops, spatulas, dippers, sampling bottles) used in the warehouse and QC laboratories of [Company Name].

3.0 Responsibility

• Warehouse/QC Personnel: To clean and handle sampling equipment as per this SOP.

• Engineering Department: To provide preventive maintenance and repair as required.

• QA Department: To verify and ensure compliance with GMP during usage and cleaning.

4.0 Definitions

• Sampling Equipment: Tools used for drawing representative samples from raw materials, intermediates, or products.

• Cleaning Validation: Documented evidence that cleaning procedure consistently removes residues to a pre-defined acceptable level.

5.0 Materials and Equipment

• Approved cleaning agent/disinfectant (as per cleaning matrix)

• Purified water/Water for Injection (WFI) as applicable

• Clean lint-free cloths/swabs

• Detergent solution (validated for pharmaceutical use)

• Cleaning brushes (dedicated and clean)

• Protective gloves, gown, mask

6.0 Procedure

6.1 General Precautions

1. Use only cleaned and labeled sampling equipment for each sampling operation.

2. Sampling equipment must be dedicated for each product category (e.g., API vs. excipients) or cleaned/validated between uses.

3. Damaged, corroded, or rusted equipment must not be used.

6.2 Cleaning Procedure (After Each Use)

1. Transfer used equipment to the designated cleaning area.

2. Rinse equipment with purified water to remove adhering powder/material.

3. Wash thoroughly with approved detergent solution using a clean brush.

4. Rinse with purified water until no visible residue remains.

5. Perform a final rinse with purified water/WFI (depending on criticality).

6. Dry equipment with a clean lint-free cloth or in a controlled drying area (drying oven or laminar airflow if applicable).

7. Inspect visually for cleanliness.

8. Label as “Cleaned” with date, time, and operator’s initials.

6.3 Maintenance Procedure

1. Inspect equipment routinely for physical condition (e.g., bends, dents, rust, cracks).

2. Ensure all joints and screws are intact and smooth (no sharp edges that may shed particles).

3. Lubricate movable parts with pharmaceutical-grade lubricant if required.

4. Replace damaged or worn-out equipment immediately and record in the Equipment History Log.

5. Calibrate volumetric sampling devices (if any) as per calibration SOP.

6. Maintain preventive maintenance schedule in coordination with Engineering.

6.4 Storage

1. Store cleaned equipment in designated cabinets or racks labeled “Clean Sampling Equipment.”

2. Use closed covers/bags to prevent contamination.

3. Keep segregated by type and usage (API/excipient/finished product).

6.5 Cleaning Verification (If Applicable)

1. Periodically verify cleaning effectiveness by swab/rinse testing (as per cleaning validation protocol).

2. Record results in the cleaning validation report.

7.0 Documentation

• Sampling Equipment Cleaning Log (date, time, material, cleaned by, checked by).

• Sampling Equipment Maintenance Log.

• Equipment History Card/File.

8.0 References

• WHO TRS Guidelines

• EU GMP Annex 8 (Sampling of starting and packaging materials)

• ICH Q7 (GMP for APIs)

• USFDA 21 CFR Part 211

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