Steam Sterilisation of Calcium Chloride

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Hi,

Recently we have begun some pre-validation trials on steam sterilisation on various products filled into vials.

The good thing is that 2 of the 3 products we are sterilising are passing the BI test. The problem I am having, and my question to you, is there a relationship between Calcium Chloride and Geobacillus stearothermophillus which will not allow for the BI to acheive optimal sterilisation?

My colleagues and I are very confused as to why this is happening. The supplier is also unsure as to why this occurs.

I was wondering if anyone else has had the same/similar problem with the sterilisation of Calcium Chloride before?

Any response is appreciated.

Thanks,

Dimitri

2

Yes they have different sporulation responses in different composition of media especially when you have calcium.