Analysis of a pharmaceutical solution filled in a class C room shows that there are 1000 viable bacteria per ml. After h

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Analysis Of A Pharmaceutical Solution Filled In A Class C Room Shows That There Are 1000 Viable Bacteria Per Ml After H 1 (33.7 KiB) Viewed 65 times

Analysis of a pharmaceutical solution filled in a class C room shows that there are 1000 viable bacteria per ml. After heat sterilising with moist heat for 6 minutes at 115°C/10 psi there were 8 viable bacteria per ml remaining. i) Calculate the time required to kill 90% of the bacteria. ii) Determine if 1 ml vials will be safe to use after a 10 minute sterilisation run. Fir iii) Calculate the sterilisation time required to reach a SAL (106,1 per million containers) for 1 mL vials. iv) Calculate the sterilisation time required to reach a SAL (10-6, 1 per million containers) for 25 mL vials.