MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS

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MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS
Module 3

• Presented by
• Deryck Smith Consulting Engineers

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GMP Manufacturing Environments

• Air Handling Systems
• HVAC Systems
• Heating
• Ventilation
• Air Conditioning
• Module 3 Types Configurations of
• AC Systems

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GMP Manufacturing Environments

• Topics for this Module
• Putting system components together
• Airflow patterns
• Locations of air terminals
• Airflow problems
• Operator protection ?

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Putting the Components Together

• In the last module we looked at some of the
  different components that can be used in an air
  handling system.
• Now we will look at different ways of putting
  these together.
• The systems must be correctly assembled to serve
  the manufacturing facility in a safe and reliable
  manner. ?

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Component Assembly
Secondary Filter
Supply Air Fan
Cooling Coil
Primary Filter
HEPA Filter
Supply air to Production area
Is there anything wrong with this arrangement?
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Component Assembly
Secondary Filter
HEPA Filter
Primary Filter
Supply Air Fan
Cooling Coil
Supply air to Production area
This looks better!
Or is it better?
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Component Assembly
Secondary Filter
Supply Air Fan
Primary Filter
Cooling Coil
HEPA Filter
Supply air to
Production area
Thats much better!
HEPA filter must be the very last component !
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Full Fresh Air
Humidifier
Secondary Filter
HEPA Filter
Cooling Coil
Supply Air Fan
Primary Filter
Exhaust Air Fan
Secondary Filter
Primary Filter
HEPA Filter
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Re-circulation Air System
HEPA Filter
Secondary Filter
Primary Filter
SA Fan
Cooling Coil
HEPA filters must be installed!
ISPE Baseline Vol. 2 6.3.3 (d)
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Terminal Filtration
Sec. Filter
Primary Filter
SA Fan
Cool Coil
Horizontal and Vertical Uni-directional flow.
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Airflow Patterns
Uni-directional Airflow
Turbulent Airflow
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Low Level Extract Is Ideal
Low level extract grilles
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Uni-directional (Laminar) Airflow Protection
Systems (1)
Cabin/ Booth
Ceiling
Workbench (vertical)
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Uni-directional (Laminar) Airflow Protection
Systems (2)
Integrated Vertical Flow
Integrated Horizontal Flow
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Airflow Patterns Contamination

• Airflow patterns play an important role in
  preventing contamination and cross-contamination.
• Airflow direction is also important in providing
  operator protection from dust inhalation.
• Some examples follow. ?

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Weigh Booth Protection
Horizontal uni-directional airflow protects the
operator.
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Poor Design Weigh Booth
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Airflow Problems (1)
Vertical airflow out of bin!
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Airflow Problems (2)
Flow reversal off table!
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Airflow Problems (3)
Air deflected off scale!
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Air Showers
Air showers can be used to remove dust from
operators thus preventing cross-contamination
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Operator Protection
Questions Answers