5 visit a gmp facility

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5 visit a gmp facility

  1. 1. Visit a GMP Facility
  2. 2. Sampling and weighing Powder Floor ScaleContainer
  3. 3. Weighing
  4. 4. Granulation
  5. 5. Blending
  6. 6. Blister line
  7. 7. AHU
  8. 8. Bioreactor
  9. 9. Sanitary fitting
  10. 10. Sanitary Diaphram Valve
  11. 11. Sanitary Connection any problems?
  12. 12. Sanitary fittings?
  13. 13. Walk in fume hood
  14. 14. CIP vs. SIP
  15. 15. Sample storage
  16. 16. WFI storage tank
  17. 17. Water pre treatment skid
  18. 18. Reverse Osmosis (RO)
  19. 19. Water for Injection (WFI) still
  20. 20. Downstream Processing
  21. 21. QC lab (what is wrong?)
  22. 22. QC lab (what is wrong?)
  23. 23. Quarantined and Rejected
  24. 24. lab
  25. 25. Lab, any problems?
  26. 26. Old skid
  27. 27. Inside old skid
  28. 28. Protective equipment?
  29. 29. Protective equipment?
  30. 30. What is wrong??
  31. 31. What is wrong??
  32. 32. Large Scale
  33. 33. Fermentation Suite
  34. 34. Filtration
  35. 35. Sterile Fills
  36. 36. Sterile Fills
  37. 37. US Class for Clean Rooms maximum particles/ft³ ISOClass equivalent ≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm1 35 7 3 1 ISO 310 350 75 30 10 ISO 4100 750 300 100 ISO 51,000 1,000 7 ISO 610,000 10,000 70 ISO 7100,000 100,000 700 ISO 8
  38. 38. maximum particles/m³ FED STDClass ≥0.1 ≥0.2 ≥0.3 ≥0.5 209E ≥1 µm ≥5 µm equival µm µm µm µm entISO 1 10 2ISO 2 100 24 10 4ISO 3 1,000 237 102 35 8 Class 1ISO 4 10,000 2,370 1,020 352 83 Class 10 ClassISO 5 100,000 23,700 10,200 3,520 832 29 100 1,000,0 ClassISO 6 237,000 102,000 35,200 8,320 293 00 1000 ClassISO 7 352,000 83,200 2,930 10,000 3,520,0 ClassISO 8 832,000 29,300 00 100,000 35,200, 8,320,0 RoomISO 9 293,000 000 00 air
  39. 39. • http://link.brightcove.com/services/link/bcpid 1541043091/bctid1541121027• The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies• http://www.phrma.org/
  40. 40. Questions???

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