Qualification Procedure for Vial Washing Machine

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Qualification Procedure for Vial Washing Machine

🧪 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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