Autoclave gravity cycle

GOOD VALIDATION PRACTICE (cGVP)
1

My enquiry is that can we take Non-Porous load validation without heat distribution three cycle if we have already taken for Porous cycle?
Is it nessary to take Minimum & maximum load for both the cases Porous & Non-Porous load. If we want to validate our Non-Porous load with on general std. qty.(suppose that 1000 ml) of suspension with only three loads, can we take cycle for 200, 300, 500, etc in between 1000 ml?

2

[quote=Aman Katoch]My enquiry is that can we take Non-Porous load validation without heat distribution three cycle if we have already taken for Porous cycle?
Is it nessary to take Minimum & maximum load for both the cases Porous & Non-Porous load. If we want to validate our Non-Porous load with on general std. qty.(suppose that 1000 ml) of suspension with only three loads, can we take cycle for 200, 300, 500, etc in between 1000 ml?[/quote]

Dear Aman,

You can take max mass configuration of porous and non-porous load instead of minimum load, because heat penetration is depend of load quantity(by weight).

Thanks

3

For every load (porous, non porous) we use three cycle:

  1. empty chamber heat distribution

  2. full load chamber heat distributon

  3. heat penetration

  4. and 3) we take with that load we want to validate, and thats the load that simulate real situation.
    Greets

4

Dear Aman,

I would like to comment this way:
The loading pattern for porous and non-porous loads will definitely be different. So, the heat distribution pattern also may be affected.
Further, for example, consider garments as porous load and a stainless steel item (which may big in size and mass) as non-porous load. In case of porous load air removal is difficult, but if the air removed steam penetration is easier. While in case of non porous load air removal is easier but the solid mass required more energy / heat to achieve the sterilization temperature. Both the phenomenons are different and may affect the heat distribution.

While talking about Validation of maximum and minimum loads, let me interpret in this way: it is obvious that the maximum load occupies more space in the Autoclave in comparison of the minimum load. Incase of maximum load the quantity of air to be removed from the chamber is lesser than minimum load. So, as far as minimum load is concern, is a challenge or is a worst case with respect to air removal from the chamber. And the maximum load is a challenge or is a worst case with respect to attaining of sterilization temperature in the loaded articles.

So, considering above logic, I suggest, consider both Maximum and Minimum loading patterns for Validation.

Regards,
Jasbindersingh
(kamal.consultants@hotmail.com) [/font]