Performance Qualification

AS5369:2023 Compliant Performance Qualification & Re-Qualification Services

At Proline Medical, we specialise in ensuring that your reprocessing and sterilising equipment operates at its highest standards of performance and compliance. Our comprehensive performance qualification and re-qualification services adhere to the latest AS5369:2023 and associated ISO & EN Standards, covering a wide range of equipment used across Central Sterilising Supply Departments, Endoscopy Departments, Operating Theatres, Hospital Wards, and Oral Health facilities.

Our Expertise

  • Performance Qualification & Re-Qualification Services

    We provide thorough performance qualification (PQ) and re-qualification (RQ) for the following types of equipment:

    • Steam Sterilisers: Ensuring effective sterilisation cycles through precise validation and verification.
    • Low-Temperature Sterilisers: Validating the performance of equipment using alternative sterilisation methods.
    • Washer Disinfectors: Testing to confirm efficient cleaning and disinfection of re-usable medical devices.
    • Ultrasonic Cleaners: Ensuring optimal ultrasonic cleaning performance for thorough contamination removal.
    • Heat Sealers: Validating seals to ensure the integrity and sterility of packaging materials.
    • Drying Cabinets / Endoscope Drying Cabinets: Ensuring effective drying processes to prevent contamination and maintain instrument integrity.
    • Automated Endoscope Reprocessors: Confirming the performance of endoscope cleaning and reprocessing systems.
    • Flusher Sanitisers: Testing for effective sanitation and flushing of equipment to ensure hygiene.
    • Hydrogen Peroxide & UV Disinfection Systems: Validating the efficacy of disinfection systems to meet stringent hygiene standards.

 

Why AS5369:2023 Compliance Matters

  • AS5369:2023 sets the benchmark for the performance qualification and re-qualification of medical equipment. Compliance with this standard ensures that:

    • Regulatory Adherence: Your equipment meets all regulatory and safety requirements.
    • Operational Efficiency: Equipment operates optimally, reducing the risk of malfunctions and ensuring reliable performance.
    • Patient Safety: Effective sterilisation and disinfection processes are maintained, safeguarding patient health.

Our Service Process

  1. Initial Assessment: We conduct a detailed assessment of your equipment and operational procedures.
  2. Qualification Testing: Comprehensive testing is performed to validate the performance of your equipment according to AS5369:2023 standards.
  3. Documentation & Reporting: Detailed reports are provided, including compliance certificates and recommendations for any required adjustments.
  4. Re-Qualification: Regular re-qualification services ensure ongoing compliance and performance consistency.
 

Why Choose Proline Medical

  • Certified Expertise: Our team of specialists is trained and certified in AS5369:2023 and associated ISO and EN Standards.
  • Comprehensive Coverage: We offer testing for a wide range of reprocessing and sterilisation equipment.
  • Quality Assurance: We provide detailed documentation and reporting to support regulatory compliance.
  • Customer-Centric Approach: Tailored solutions to meet the specific needs of your facility, ensuring minimal disruption to your operations.
 

Contact Us

Ensure your equipment meets the highest standards of performance and compliance. Contact Proline Medical today to learn more about our AS5369:2023 compliant services and schedule an assessment.

Proline Medical – Your partner in maintaining the highest standards of disinfection and sterilisation performance