Sterilization tunnel and Dry Heat Sterilizator Validation

Hello all friends,

I need your help. I will make validation our ST (sterilization tunnel) and DHS (dry heat sterilizator) for vials. Which temparature / which minute i must make validation? And where write this conditions in Europan Pharmacopoeia, BP, USP, Eudralex or another literature? I need temprature and time table about that validation. I wait yours precious answer.

Best regards.

[quote=ireligil]Hello all friends,

I need your help. I will make validation our ST (sterilization tunnel) and DHS (dry heat sterilizator) for vials. Which temparature / which minute i must make validation? And where write this conditions in Europan Pharmacopoeia, BP, USP, Eudralex or another literature? I need temprature and time table about that validation. I wait yours precious answer.

Best regards.[/quote]
I thought you can get the imformation from PDA report dry heat, FDA guideline about sterilization. There are many good knowledge about dry heat validation.

PDA TR No.3 is very good book for this. You should know that if you validate depy process no need for validation of sterilization. If you need more infprmations send me private message.

Nice posts guys!