Biological Bottle Pack Validation

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Hi All

Do somebody maybe have a expirience with Bottle Pack BI Validation?
My question is how to fix and what kind of BI Indicators i can use in pipes and nozzles?

Thank you all!
Regards

2

These days you are getting BIOBAL - a small ball which contains exact number of spores. I think this is produced in France. You can put that ball into a small tube or pipe or nozzle.

3

Thanks,
Do you maybe have an web site of customer, do somebody have expirience in this?
Thanks

4

http://www.btfbio.com/index.php

You can mail them and ask your possible applications.

5

Thank you for info but these balls are water soluble, can it be putted in the steam sterilization?
How you can fix it in pipes?

[quote=DURGA PRASAD]
http://www.btfbio.com/index.php

You can mail them and ask your possible applications.[/quote]

6

It can be properly used in valves, dead spaces, Pipes etc.One need to design such a protocol and prove with evidence. It must have a strong scientific data so that regulators get convinced.
These days regulatory authorities accepting new protocols and validation methods.

Strong science is what all we need with a bit of commonsence.

Regards

7

Very nice comment, Now-a-days hard to see such comments :

“Strong science is what all we need with a bit of commonsence”