Heating Ventilation and Air Conditioning (HVAC)

1
Heating Ventilation and Air Conditioning (HVAC)
Part 3 Workshop on GMP and Quality Assurance
of TB products Kuala Lumpur Malaysia, 21 25
February 2005 Maija Hietava M.Sci.Pharm Quality
Assurance and Safety Medicines, Medicines Policy
and Standards, Health Technology and
Pharmaceuticals Cluster Tel [phone] Fax
41.22.791.4730 World Health Organization E-mail
hietavam_at_who.int
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Characteristics of air handling systems

• In the following slides, we will study
  alternatives in air handling systems
• Turbulent or uni-directional airflows
• Filter position
• Air re-circulation vs fresh air
• Return air systems (positions)
• Overpressure requirements

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Air flow patterns (1)

• Uni-directional / laminar
• displacement of dirty air

• Turbulent
• dilution of dirty air

0,30 m/s
4
Air flow patterns (2)

• Filtered air entering a production room or
  covering a process can be
• turbulent
• uni-directional (laminar)
• GMP aspect
• economical aspect
• New technologies barrier technology/isolator
  technology.

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Question no 19 Turbulent and unidirectional
air are called what??
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Annex 1, 17.3
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Air flow patterns (4)
Workbench (vertical)
Cabin/ booth
Ceiling
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Positioning of filters (1)

AHU mounted final filter
Filter in terminal position
HEPA Filter
HEPA Filter
9
Positioning of filters (2)
Prefilter
AHU
Main filter
Ceiling exhausts
2
3
1
Low level exhausts
10
(No Transcript)
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Air re-circulation

• The filtered air entering a production room can
  be
• 100 exhausted or
• a proportion re-circulated
• GMP aspect
• economical reasons

12
Ventilation with 100 fresh air (no air
re-circulation)
Washer (optional)
Exhaust Unit
W
Central Air Handling Unit
Production Rooms
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Ventilation with re-circulated air make-up air
Exhaust Unit
Central Air Handling Unit
Return air
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Definition of Conditions
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• Question no 20
• Air is often recirculated in production area
  because of __________ reasons.

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Qualification / Validation issues

• A good design is essential, but it has to be
  complemented by
• Qualification of air handling systems
• Process validation
• Maintenance and periodic re-qualification
• Adequate documentation

17
Qualification (OQ, PQ) (1)
18
Qualification (OQ, PQ) (2)
IQ tests are not mentioned on this slide
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Microbiological validation

• Definition of alert / action limits as a function
  of
• cleanliness zone
• Identification and marking of sampling points
• Definition of transport, storage, and incubation
  conditions

Ask the question What are the alert and action
Limits and what procedures are followed if these
points are exceeded?
20

• Question no 21
• For microbiolgical environmental monitoring there
  have to be _______ and action limits in place.

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Cleanroom monitoring program (1)
Cleanrooms should be monitored for
micro-organisms and particles
air
Sampling point
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Cleanroom monitoring program (2)

• Routine monitoring program as part of quality
  assurance
• Additional monitoring and triggers
• Shutdown
• Replacement of filter elements
• Maintenance of air handling systems
• Exceeding of established limits

23
Cleanroom maintenance program (1)
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Cleanroom maintenance program (2)
25

• Question no 22
• When going over the limits in microbiological
  monitoring ____________ sampling has to be
  carried out.

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Documentation requirements

1. Description of installation and functions
2. Specification of the requirements
3. Operating procedures
4. Instructions for performance control
5. Maintenance instructions and records
6. Maintenance records
7. Training of personnel (program and records)

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Inspecting the air handling plant

• Verification of design documentation, including
• description of installation and functions
• specification of the requirements
• Operating procedures
• Maintenance instructions
• Maintenance records
• Training logs
• Environmental records
• Discussion on actions if OOS values
• Walking around the plant

28
Question no 23 What is the basic requirement
for all the equipment in pharma industry? It is
very critical especially for air conditioning
unit.
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Conclusion

• Air handling systems
• Play a major role in the quality of
  pharmaceuticals
• Must be designed properly, by professionals
• Must be treated as a critical system