GUIDELINES ON HVAC SYSTEMS FOR NON-STERILE PHARMACEUTICAL PRODUCTS (Lastest Version) – Free PDF download

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DESIGN OF HVAC SYSTEMS AND COMPONENTS

HVAC systems should be appropriately designed and managed throughout their life cycle.
Documentation such as schematic drawings should be maintained to reflect the current  situation, including but not limited to, air supply and extraction, air handling units, room
pressure cascades, air flow direction, personnel and material movement, and waste removal.

5.1. Risk management principles should be applied during the design of an HVAC system.
This includes, but is not limited to, appropriate controls of the climatic conditions and the
prevention of contamination and cross-contamination.

5.2. The HVAC system capacity should be sufficient to ensure that the required
performance is maintained during normal use.

5.3. Materials of construction for components of an HVAC system should not become a
source of contamination.

5.4. Where possible, ducting, piping, fittings, sensors and other components should be
clearly marked or labelled for ease of identification, location and direction of flow as
appropriate.

5.5. Air intake and exhaust air terminals should be positioned in a manner in relation to
one another that assist in preventing cross-contamination.

5.6. Air-handling units (AHUs) should be provided with adequate drains to remove
condensate that may form in the AHU.

 

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Continue at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/HVAC-QAS15-639Rev2-05072017.pdf

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