Design of HVAC systems and components
Proper design and management of HVAC systems is crucial throughout their entire life cycle. It is important to maintain documentation, such as schematic drawings, to accurately reflect the current state of the system.
To ensure the safety and effectiveness of HVAC systems, risk management principles should be applied. This includes appropriate design, operation, and monitoring, as well as controlling climatic conditions and preventing contamination and cross-contamination.
The capacity of the HVAC system should be sufficient to maintain the required performance under normal usage. Factors such as room leakage, duct leakage, and filter conditions should be taken into consideration.
Materials for constructing the components of an HVAC system should not become a source of contamination.
Whenever possible, ducting, piping, fittings, sensors, and other components should be clearly marked or labeled for easy identification. This should include indicating their location and the direction of flow, as appropriate.
Air intake and exhaust air terminals should be positioned in a way that minimizes the risk of cross-contamination.
Also read – High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE
Air-handling units (AHUs) should be equipped with properly designed drains to effectively remove any condensate that may accumulate.
Conditions and limits for parameters such as temperature, relative humidity and air cleanliness should be specified and achieved, as needed, for the materials and products handled, as well as for process risk.
Specific conditions and limits for parameters such as temperature, relative humidity, and air cleanliness should be specified and achieved as necessary. This applies to the materials, products, and process risks involved.
The analysis of critical components should include an examination of failure modes and their effects. This analysis should specifically consider the potential changes in room pressure caused by fan failure and the impact of a partial system shutdown on the ability to open doors for escape purposes.
To ensure proper air distribution and airflow patterns, it is important to locate air supply and extract grilles in appropriate positions. This will help to effectively flush the room and prevent the formation of stagnant air zones.
Air supply and extract grilles should be appropriately located to provide effective room flushing and to prevent zones of stagnant air.
The performance of HVAC systems should be closely controlled and monitored to ensure continuous compliance with defined parameters. Records should be maintained to track system performance, and the limits defined should be justified based on industry standards and requirements.
When automated monitoring systems are utilized, they should be capable of indicating any out-of-limit conditions through an alarm or similar system. If these systems are identified as GXP systems, they should undergo appropriate validation to ensure their reliability and accuracy.
To alert personnel in the event of a critical component failure, such as a fan, appropriate alarm systems should be in place. It is also important to assess the potential effects of fan failure on the building and HVAC components. In cases where it is necessary, a fan interlock failure matrix should be implemented to mitigate any potential risks.
It is advisable to avoid periodic switching off of Air Handling Units (AHUs), such as overnight or during non-production hours, or reducing supply air volumes. This is to prevent any compromise in material or product quality. If AHUs need to be switched off, there should be a valid justification and measures in place to ensure no risk to materials or products. The procedure for startup and shutdown of AHUs should be established ,in place and records documented, and followed consistently.
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