1. Risk Issues in the Design and Operation of Aseptic Processing Facilities Nancy Tomoney Associate Validation Manager Q Pharma Inc. Gowning Rooms and Procedures

5. Identifying Risks

6. EU Annex 1 No mention of gowning areas

7. US FDA Gowning is therefore a support area, a clean area that needs to be controlled.

8. USP Other support areas sample once to twice a week. Bad suggested practice often applied to gowning areas.

10. Layouts OK, But Not Ideal

11. Layouts Better

12. Layouts Best

24. Good HVAC (Critical Areas) Atypical Class 100, usually in hoods and for potent compounds Typical Class 100, for sterile nonpotent compounds Class 10,000 or 100,000 areas, controlled but not always critical Non drug

26. Air Disturbance

27. Contamination Control

30. Bad HVAC Design in Best Room

31. Better HVAC Design in Best Room

32. Gowning

33. Design Risks

60. Non Sterile Gowning

61. Non Sterile Gowning

62. Sterile Gowning