Reg: Autoclave Risk assessment

Dear Sir,

Can i get autoclave risk assessmentprotocol for its qualification.

Suman,

This is not possible as there are many different types of autoclaves
so a generic protocol would not be sufficient.

Regards

Dear Sir,

We are using autoclave which is having HPHV(High pressure and High vaccum- for accessories)and satandard with out pulsing for media load.Which is dedicated for microbiologyb lab activities.So for the above autoclave what kind of risk assessment we can approach.

Suman,

This is a complex question, I would need to be onsite to examine the

autoclave and your validation approach. Sorry for the short answer.

This forum is more suited to more precise questions. If you have any

more specific questions feel free and I will do my best to respond.

Regards

[quote=suman]Dear Sir,

We are using autoclave which is having HPHV(High pressure and High vaccum- for accessories)and satandard with out pulsing for media load.Which is dedicated for microbiologyb lab activities.So for the above autoclave what kind of risk assessment we can approach.[/quote]

Dear Suman,

Generally, risk assessment will be done in the following stages:
DQ, IQ, OQ a& PQ.

If you want more guidance on HPHV Autoclave, better you go through PDA Techincal report number: 1

With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com

[quote=suman]Dear Sir,

Can i get autoclave risk assessmentprotocol for its qualification.[/quote]
Dear sumen,

i would like to say that risk assessment for autoclave is to be started from design of the equipment.

think that why you are using each componet in the system,if using what is the pirpose , if not what will not be in control , then you will find answer for all type of risk.

and one more think you have to risk analysis for articles sterilized loading and unloading patterns, storage conditions also…

you gan get valuable information form PDA TECH REPORT -01

HTM 2010

EN 285 GUDANCE DOCUMENTS …

Dear suman,

The autoclave validation starts right from the design stage. But that can be done retrospectively if not done earlier.
Another thing as you said you have cycle with HPHV for media load.
For the new load pattern you will have to conduct the 3 distribution cycle with the load specific load pattern distribution and 3 cycles for the heat penetration with the biological indicators i think it consists of only the porous load i.e the hard goods.

Deepak Kabbur

[COLOR=“blue”]This is very well discussed in
PDA Technical Report No.44
Quality Risk Management for Aseptic Process.
Released : 2008
Supplement Volume: 62
A whole table deals with Risk Assessment for Autoclave Failures.[/color]

Regards

1 Like

Hi Durga, can u provide me the document

[VINOD_PADMAKAR_KULKARNI]
If your company has asscess to die PDA you should be able to get it there. If you are a student it is maybe possible as you seem to be in the science area that your universcyt libary mayhave acess as well.
good luck finding it.

for some basic strting
please have a look here
PDA New Orientation Guide Second Line of Information