5 visit a gmp facility
TRANSCRIPT
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Visit a GMP Facility
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Sampling and weighing
P ow derC ontainer
F loor S cale
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Weighing
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Granulation
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Blending
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Blister line
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AHU
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Bioreactor
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Sanitary fitting
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Sanitary Diaphram Valve
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Sanitary Connectionany problems?
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Sanitary fittings?
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Walk in fume hood
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CIP vs. SIP
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Sample storage
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WFI storage tank
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Water pre treatment skid
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Reverse Osmosis (RO)
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Water for Injection (WFI) still
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Downstream Processing
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QC lab (what is wrong?)
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QC lab (what is wrong?)
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Quarantined and Rejected
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lab
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Lab, any problems?
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Old skid
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Inside old skid
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Protective equipment?
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Protective equipment?
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What is wrong??
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What is wrong??
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Large Scale
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Fermentation Suite
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Filtration
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Sterile Fills
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Sterile Fills
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US Class for Clean Rooms
Class
maximum particles/ft³ISOequivalent≥0.1
µm≥0.2 µm
≥0.3 µm
≥0.5 µm ≥5 µm
1 35 7 3 1 ISO 3
10 350 75 30 10 ISO 4
100 750 300 100 ISO 5
1,000 1,000 7 ISO 6
10,000 10,000 70 ISO 7
100,000 100,000 700 ISO 8
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Class
maximum particles/m³FED STD 209Eequivalent
≥0.1 µm
≥0.2 µm
≥0.3 µm
≥0.5 µm ≥1 µm ≥5 µm
ISO 1 10 2
ISO 2 100 24 10 4
ISO 3 1,000 237 102 35 8 Class 1
ISO 4 10,000 2,370 1,020 352 83 Class 10
ISO 5 100,000 23,700 10,200 3,520 832 29 Class
100
ISO 6 1,000,000
237,000
102,000 35,200 8,320 293 Class
1000
ISO 7 352,000 83,200 2,930 Class
10,000
ISO 8 3,520,000
832,000 29,300
Class 100,00
0
ISO 9 35,200,000
8,320,000
293,000
Room air
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• http://link.brightcove.com/services/link/bcpid1541043091/bctid1541121027
• The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies
• http://www.phrma.org/
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Questions???