HVAC System Validation

December 31, 2021 By Kewaunee International Group Comments are Off , , , ,

HVAC System Validation Guidelines

Heating, Ventilation, and Air Conditioning (HVAC) is a much-required equipment in any laboratory. It controls how the temperature, humidity, and air flow works within the room. It’s critical to the functioning of any laboratory, especially those that make use of hazardous materials.

In this infographic, we will look at how a HVAC system is validated before installation, and what aspects need to be considered for the same. If you’re looking to commission such devices for your laboratory, you can have a look at our range of products here: https://www.kewaunee.in/ventilated-devices.php

Tests Acceptance Criteria
Air Flow Pattern
  • Air flow should be from the higher pressure zone to the lower pressure zone in the room
  • The air flow must be unidirectional only
  • It must be recorded using video
Air Flow Velocity & Change Per Hour
  • It should be ensured that the measured air quantity must be more than the designed air quantity & calculated air changes
  • Average air velocity of laminar flow = 90 +/- 20%
Filter Leak Test
  • Penetration of 0.03% of particles is unacceptable (0.3 nm & larger than reference calibration curve of 99.97% efficient filters)
  • Penetration of 0.01% of particles s unacceptable (0.3 nm & larger than reference calibration curve of 99.99% efficient filters)
Particles Count
  • Particle concentration should not exceed 3500 for 0.5 mm size and 0 for 5.0 mm size (at rest or in operation)
Viable Monitoring
  • Grade A/5 – <1 CFU/plate limit
  • Grade B/6 – <5 CFU/ plate limit
  • Grade C/7 – <50 CFU/ plate limit
  • Grade D/8 – <100 CFU/ plate limit
Filter Integrity Test
  • Leakage rate must be less that 0.01% NMT and zero leakage at joints
Pressure Difference
  • Recorded once every 72 hours but the acceptance criteria depends on the specifications on the instrument
Recovery (Temperature & Humidity)
  • For any parameter, recovery time should not be over 15 minutes excluding viable count
Temperature & Humidity Uniformity Test
  • For either parameter, the temperature and humidity must be agreed upon between the lab supervisor and commissioning company
Fresh Air Determination
  • The intake of fresh air must be calculated for each HVAC cycle and acceptance criteria depends on the specifications of the instrument

Source: Pharma Guidelines, n.d.

Kewaunee, the global leader in total laboratory solutions, empowers organisations to achieve competitive advantage through safe, efficient, and contemporary laboratories. In existence since 1906, Kewaunee powers the laboratories for over 5,000 customers in more than 100 countries.

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