F0 product Flashcards
what SAL do compendial cycles require?
min of 10-6
what is the typical cycle/
15 minutes at 121 degrees
what is a problem of compenidal cycle/
product degradation - some process we may over process and this would lead to degradation
economically wasteful and expensive
what is compendial lethality?
bacteria don’t wait until temperature to start dying, most die around 60 degrees, some spores will be killed around 100 degrees. During heating up process some bacteria will be dying.
Therefore we need to be able to measure total lethality!
what is the F0 value?
The lethality expressed in terms of the equivalent time in minutes at a temperature of 121oC delivered by the process to the product in its final container with reference to microorganisms possessing a z-value of 10.
- allows you to compare lethaties
how do you calculate F0?
1.) Biological Data
• Relationship between F0 and D values
F = D (logN0 - Log N)
• D is the D-value at the given temp.
• N0 is the initial number of microorganisms present (bioburden)
• N is the number of microorganisms surviving the process (actual or expected)
2.) Thermal date (more accurate, not using living organisms)
when would you use f0?
- The values allow you to find alternatives to compendial cycle.
- Allows lethality’s to be compared against standard set of conditions
- Can be used for heat labile products
- Offers greater flexibility for heat sterilization
- Accepted by regulatory bodies
what is the equation for F0 thermal data?
f0=10(T-121/Z) x dt
z is ALWAYS 10
dt = time taken to heat
T= temp
what is equation for Fh?
Fh= 10(T-170/z) x dt
z is 20
dt= time taken
t=temp
what is the relationship between F and D?
F= d(logn0 - logN)
d= the d value at a set temp
log n0= log of the number of m/o at the beginning
logN= log of the number of surviving m/o
