🧪 Qualification Procedure for Vial Washing Machine

A Vial Washing Machine is a critical equipment in sterile manufacturing, ensuring removal of particulate and microbial contamination before sterilization and filling. Its qualification ensures consistent performance in compliance with GMP.

1. Design Qualification (DQ)

• Verify design and vendor documentation.

• Check compliance with URS (User Requirement Specification).

• Ensure:

  • Contact parts are SS 316L, non-corrosive, smooth, non-shedding.

  • Proper water connections (WFI, Purified Water, Compressed Air).

  • Drainage system design avoids contamination.

  • Machine supports required vial sizes.

  • Control system is 21 CFR Part 11 compliant (if computerized).

2. Installation Qualification (IQ)

• Verify machine installation as per layout and P&ID.

• Check utilities: electrical, water, compressed air, drain.

• Calibration certificates for gauges, flow meters, timers, temperature sensors.

• Verify safety features: emergency stop, guards.

• Ensure piping & valves are passivated and properly labeled.

• Cross-check spare parts list and documentation (manuals, SOPs).

3. Operational Qualification (OQ)

• Dry run tests without vials.

• Verify washing cycles (pre-wash, detergent wash if applicable, WFI rinse, air blowing).

• Check sequence and timing of nozzles.

• Verify spray pressure and flow rate.

• Test water consumption per cycle.

• Alarms & interlocks:

  • Door not closed → cycle doesn’t start.

  • Utility failure → machine stops safely.

• Data logging & control system functionality.

4. Performance Qualification (PQ)

• Load machine with actual vial sizes (e.g., 2 mL, 10 mL, 20 mL).

• Run multiple cycles under normal operating conditions.

• Sampling & Testing:

  • Particulate contamination (visual & by particle counter, as per USP <788>).

  • Microbiological contamination – rinse water test, swab test inside vials.

  • Residue check – test rinse water for TOC/conductivity to ensure no detergent/WFI contamination.

• Verify drying efficiency (no residual water droplets).

• Demonstrate reproducibility with 3 consecutive successful runs.

5. Requalification

• Annually or as per SOP.

• After major maintenance/repair (pump replacement, nozzle change).

• After relocation or utility modification.

6. Documentation

• Qualification Protocol (DQ, IQ, OQ, PQ).

• Test records & calibration certificates.

• Final Qualification Report with deviations, CAPA, and approval.

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