Cleanroom Validation and Testing – Theory & Practice


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All our courses continue to evolve as standards and best practice change, and when we get feedback from previous delegates.  A general guide to what is included over the 2 days is below:

Cleanroom Introduction

A practical Demonstration covering:

  • Room air flows through supply grilles (Balometer and Air Flow / Velocity Meter)
  • Room air change rate calculations
  • Room differential pressure testing & Magnehelic Gauge calibration (Micro Manometer)
  • HEPA filter Installation Leak testing (DOP)(Photometer and Aerosol Generator)
  • Comfort conditions, temperature humidity, noise and light level checks; reference checks
  • Air particle count testing (Particle Counter)
  • Room recovery type testing to establish clean up rates

This will be an in-depth training course with an “open book” style exam.  Greater than 90% must be achieved to be awarded a Pass Certificate.  Any delegate not sitting the exam or not meeting the required standard will be awarded a Certificate of Attendance.

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Maintaining a cleanroom to the relevant standards is often controlled by Quality assurance personnel, who may have limited  understanding of the standards applied to the design of the facility, and the practicality of building controls parameters such as HVAC, drains, pressure differentials people movement, particle monitoring etc. This course will not only give a fundamental background on the relevant standards in relation to cleanrooms and the expected contamination and microbial limits surrounding these, but will also provide an insight into the correct  Corrective and Preventive Actions (CAPA) needed to address issues as they arise. Participants will have the opportunity to raise concerns or questions regarding  their current working environment.

Instructor – Joe Hughes

Joe Hughes is a Validation Tester and Designer of Cleanrooms, qualifed to Ae(v) to HTM 03-01 in Health Technical Memorandum. He has been carrying out specialist ventilation for Healthcare premises and Validation Testing for Operating Theatres and Specialist Healthcare for a number of years, including at Porton Down. Through his consultancy, CAS Europe, he has carried out numerous training courses for the Society in Validation & Testing.

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