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MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS

MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS. Module 3. Presented by : Deryck Smith Consulting Engineers. GMP Manufacturing Environments. Air Handling Systems HVAC Systems H eating V entilation A ir C onditioning Module 3: Types & Configurations of

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MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS

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  1. MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS Module 3 Presented by : Deryck Smith Consulting Engineers

  2. GMP Manufacturing Environments Air Handling Systems HVAC Systems Heating Ventilation Air Conditioning Module 3: Types & Configurations of AC Systems

  3. GMP Manufacturing Environments Topics for this Module: Putting system components together Airflow patterns Locations of air terminals Airflow problems Operator protection 

  4. 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. 

  5. 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?

  6. 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?

  7. Component Assembly Secondary Filter Primary Filter Supply Air Fan HEPA Filter Cooling Coil Supply air to Production area That’s much better! HEPA filter must be the very last component !

  8. Full Fresh Air Humidifier Secondary Filter HEPA Filter Cooling Coil Supply Air Fan Primary Filter Exhaust Air Fan Secondary Filter Primary Filter HEPA Filter

  9. 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)

  10. Terminal Filtration Sec. Filter Primary Filter SA Fan Cool Coil Horizontal and Vertical Uni-directional flow.

  11. Airflow Patterns Uni-directional Airflow Turbulent Airflow

  12. Low Level Extract Is Ideal Low level extract grilles

  13. Uni-directional (Laminar) Airflow Protection Systems (1) Workbench (vertical) Cabin/ Booth Ceiling

  14. Uni-directional (Laminar) Airflow Protection Systems (2) Integrated Vertical Flow Integrated Horizontal Flow

  15. 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. 

  16. Weigh Booth Protection Horizontal uni-directional airflow protects the operator.

  17. Poor Design Weigh Booth

  18. Airflow Problems (1) Vertical airflow out of bin!

  19. Airflow Problems (2) Flow reversal off table!

  20. Airflow Problems (3) Air deflected off scale!

  21. Air Showers Air showers can be used to remove dust from operators thus preventing cross-contamination

  22. Operator Protection Questions & Answers

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