2. 1 MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS Presented by : Deryck Smith Consulting Engineers Module 3

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

4. 3 GMP Manufacturing Environments Topics for this Module: 1. Putting system components together 2. Airflow patterns 3. Locations of air terminals 4. Airflow problems 5. Operator protection 

5. 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. 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. 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.  The systems must be correctly assembled to serve the manufacturing facility in a safe and reliable manner. 

6. 5 Component Assembly Is there anything wrong with this arrangement? Supply air to Production area Cooling Coil Supply Air Fan HEPA Filter Secondary Filter Primary Filter

7. 6 Component Assembly This looks better! Or is it better? Supply air to Production area Cooling Coil Supply Air Fan HEPA Filter Secondary Filter Primary Filter

8. 7 Component Assembly That’s much better! Cooling Coil Production area Supply Air Fan HEPA Filter Primary Filter HEPA filter must be the very last component ! Secondary Filter Supply air to

9. 8 Full Fresh Air Primary Filter Cooling Coil Humidifier Supply Air Fan Secondary Filter HEPA Filter Primary Filter Secondary Filter HEPA Filter Exhaust Air Fan

10. 9 Re-circulation Air System ISPE Baseline Vol. 2 #6.3.3 (d) SA Fan Primary Filter Cooling Coil HEPA Filter Secondary Filter HEPA filters must be installed!

11. 10 Terminal Filtration Horizontal and Vertical Uni-directional flow. Primary Filter SA Fan Cool Coil Sec. Filter

12. 11 Airflow Patterns Uni- directional Airflow Turbulent Airflow

13. 12 Low Level Extract Is Ideal Low level extract grilles

14. 13 Uni-directional (Laminar) Airflow Protection Systems (1) Cabin/ BoothCeilingWorkbench (vertical )

15. 14 Uni-directional (Laminar) Airflow Protection Systems (2) Integrated Horizontal Flow Integrated Vertical Flow

16. 15 Airflow Patterns & Contamination Airflow patterns play an important role in preventing contamination and cross- 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. Airflow direction is also important in providing operator protection from dust inhalation. Some examples follow.  Some examples follow. 

17. 16 Weigh Booth Protection Horizontal uni-directional airflow protects the operator.

18. 17 Poor Design Weigh Booth

19. 18 Airflow Problems (1) Vertical airflow out of bin!

20. 19 Airflow Problems (2) Flow reversal off table!

21. 20 Airflow Problems (3) Air deflected off scale!

22. 21 Air Showers Air showers can be used to remove dust from operators thus preventing cross-contamination

23. 22 Operator Protection Questions & Answers