Ryan Rennie www . refrigerationandaircon . co . za RACA Journal I November 2023 39
Contributor
THE STRATEGIC SEQUENCE OF HVAC VALIDATION TESTING IN CLEAN ROOM PROJECTS
By Ryan Rennie , from the Spada-Rennie Group
In the realm of clean room applications – which include semiconductor manufacturing , pharmaceutical production , biotech research and advanced electronics manufacturing – clean rooms play a paramount role .
These controlled environments ensure the integrity of critical processes . After overcoming the challenges of the construction process , it is crucial to understand that the success of the project still hinges on successful validation testing . In this article , we will delve deep into the critical significance of carefully sequencing HVAC ( Heating , Ventilation and Air Conditioning ) validation tests . We will focus on air balancing , AHU ( Air Handling Unit ) testing , the intricate pressure cascade setup , essential tests performed , and the importance of HEPA filter labelling and matching factory certificates . We will also scrutinise the adherence to design air flow thresholds and the necessity of providing comprehensive explanations when deviations occur , leading to re-testing scenarios . Additionally , we will explore the crucial elements of particle counts , air flow visualisation , recovery tests , micro tests and the importance of dated and signed reports and documentation .
UNDERSTANDING THE CLEAN ROOM VALIDATION PROCESS Before we dive into the intricacies of HVAC validation testing , let ' s establish a comprehensive understanding of the clean room validation process . Clean room validation is an exhaustive procedure designed to ensure that the clean room operates within pre-defined parameters encompassing temperature , humidity , particle count and more . This process holds immense significance , transcending industries , as it directly influences product quality , regulatory compliance and ultimately , the safety of end-users .
THE INTEGRAL ROLE OF AIR BALANCING In the systematic approach to clean room construction , prioritising air balancing as the initial step in the validation journey is essential . Air balancing takes precedence , commencing even before the deep cleaning process and often running concurrently with snagging activities . This carefully orchestrated sequence empowers the validation process to focus on the precise calibration of AHUs and the establishment of the essential pressure cascade , which plays a pivotal role in subsequent testing phases .
ESSENTIAL TESTS IN HVAC VALIDATION While these tests can be grouped under IQ ( Installation Qualification ), OQ ( Operational Qualification ) and PQ ( Performance Qualification ), it is important to highlight their significance briefly :
• Pre-filter testing : The validation process begins with evaluating the pre-filters . These filters capture larger particles , preventing them from reaching the HEPA filters . Pre-filter testing should be conducted after deep cleaning but before HEPA filter installation . Correct sequencing ensures that pre-filters are functioning optimally , reducing the risk of contaminating HEPA filters during installation .
• HEPA filter testing : Following pre-filter validation , HEPA filter installation can proceed . After installation , immediate HEPA filter testing is essential . This test verifies that the filters operate at the required efficiency , removing sub-micron particles from the air . Proper sequencing here ensures that HEPA filters are functioning optimally from the start .
By Ryan Rennie , from the Spada- Rennie Group
• Airflow testing : After HEPA filter validation , airflow testing is performed . This test examines the uniformity and direction of airflow within the clean room . Correct sequencing is crucial , as any disruption to airflow during HEPA filter installation can impact the results of this test .
Ryan Rennie www . refrigerationandaircon . co . za RACA Journal I November 2023 39