This question follows from the last question The D value for a resistant strain of bacterial spores is 0.5 kGy when radi
Posted: Tue May 17, 2022 8:12 pm
This question follows from the last question The D value for a resistant strain of bacterial spores is 0.5 kGy when radiation sterilised. Usually, a 6ºCo source delivers a 25 kGy dose in 10 minutes and is used to sterilise syringes where the typical contamination level is 100 bacteria per syringe. What is the minimum time required to ensure a SAL of 10 is achieved?
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. ii) 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.
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. ii) 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.