GMP Updated Training Modules

1
Supplementary Training Modules on Good
Manufacturing Practice
Heating, Ventilation and Air- Conditioning
(HVAC) Part 1 (b) Introduction and overview
WHO Technical Report Series, No. 937, 2006.
Annex 2
2
HVAC

• Objectives
• To continue from Part 1(a), now focus on
• Air filtration
• The role of HVAC in dust control
• HVAC system design and its components (part 2)
• Commissioning, qualification and maintenance
  (part 3)

3
HVAC

• Air Filtration
• Degree of filtration is important to prevent
  contamination
• Type of filters to be used dependent on the
  quality of ambient air, return air and air change
  rates
• Manufacturer to determine, select and prove
  appropriate filters for use considering level of
  ambient air contamination, national requirements,
  product specific requirements

4.2.1, 4.2.3
4
HVAC

• Levels of protection and recommended filtration
• Filter class should be referenced to the
  standard test method

Recommended filtration Level of protection
Primary filters, e.g. EN779 G4 Level 1
Production area with 100 outside air Primary plus secondary filter (e.g. EN779 G4 plus F8 filters) Level 2 and 3
Production area with recirculated plus ambient air with a risk of cross-contamination Primary plus secondary plus tertiary filter (e.g. EN779 G4 plus F8 plus EN1822 H13 filters) Level 2 and 3
4.2.1
5
HVAC

• Contamination should be prevented through
  appropriate
• Materials for components and construction
• Design and appropriate access to dampers, filters
  and other components
• Personnel operations
• Airflow direction
• Air distribution component design and
  installation and location
• Type of diffusers (non-induction type
  recommended)
• Air exhaust (normally from a low level)

4.2.4