| Onderstepoort Biological Products © |22nd February 2013Page 58 √ OBP √ 2008.

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| Onderstepoort Biological Products © |22nd February 2013Page 58 √ OBP √ 2008

| Onderstepoort Biological Products © |22nd February 2013Page 59 Viral vaccine manufacturing – then and now…. Open production area – high contamination risk Options of modular clean room units

Vaccine Packaging Products Liquid vaccines Freeze-dried products Diluents (water, adjuvants) | Onderstepoort Biological Products © |22nd February 2013 Capping machines Filling machine Freeze Dryer Quarantined productCarton Packing Processes Bottling/freeze-drying Capping Labeling Packing Key Challenges Redundant equipment Old equipment Open lines, no HVAC Bottlenecks Predominantly hand-packing Unlinked, unconnected processes

| Onderstepoort Biological Products © |22nd February 2013Page 61 Example of an Interlinked filling line Seale off/encaged (isolated) capping machine Seale off/encaged (isolated filling machine cleaning sterilizing filling and closing tray loading capping

| Onderstepoort Biological Products © |22nd February 2013Page 62