Validation of Steam Sterilization

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Hello all,

I’m very new to the world of autoclave validation and after viewing some of the responses to other autoclave-related questions, I’m confident that this is “the place to be.” I’ve read “Practical Guide to Autoclave Validation”, “Top 10 considerations when validating an autoclave”, and even a little of the PDA technical manual but I’m still not certain about F0. I know what it is but how do I establish F0? Is it the time the autoclave takes from start to set temp time?

2

Hi!
Its a little bit hard to explain F0 in few sentences but I ll recomend you to read “Validation of farmaceutical prosesses” from Frederick Carleton and James Agalloco and PDA Technical monograph No1 draft 16 2005 revision.
But, F0 is calculate for the whole process not only for a sterilize phase.
Fo is accumlative value and its starts from the begining of heating, but than the values are the smallest ang grow with temperature.

3

Hi!
Its a little bit hard to explain F0 in few sentences but I ll recomend you to read “Validation of farmaceutical prosesses” from Frederick Carleton and James Agalloco and PDA Technical monograph No1 draft 16 2005 revision.
But, F0 is calculate for the whole process not only for a sterilize phase.
Fo is accumlative value and its starts from the begining of heating, but than the values are the smallest ang grow with temperature.

4

Under current regulation and guidance:
Do you have to perform an autoclave minimum load validation run (3 times), with biological indicators (BI) if you;

  1. Established a temperature mapping with an empty chamber run. (with or without BI)
  2. Have performed a maximum load validation run (3 times) with BI.

I question this by looking at the big picture.

  1. What would a minimum run provide for (in data) that the maximum run has already established as a worst case scenario?
  2. If we do consider a minimum load validation run to be a separate validation then a max… are we saying that if an autoclave fails at a minimum load configuration and passes at a max load configuration that the autoclave is only valid to use in maximum run scenarios? However, that seems not logical, if it fails at any configuration determines there is a problem with the autoclave. To get this a worst case approach should be used, not best/easiest configuration.
  3. When other processes are validated take example an aseptic media run, you would not run one container through a production line to show a minimum, it is always maximums.
  4. If X Car Company produced a car it would not test it by driving it only slow and straight and then claim it was valid for high speeds and corning.

Please advice, it does not make sense to me.
Thanks for your guidance on this.

Sincerely,
Dawn