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GMP Updated Training Modules

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Good Manufacturing Practice Heating, Ventilation and Air- Conditioning (HVAC) Part 1 (b): Introduction and overview WHO Technical Report Series, No. 937, 2006. – PowerPoint PPT presentation

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Title: 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
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