Vacuum leak test acceptance criteria

Dear all
In autoclave vacuum leak test,How come the acceptance limit 0.013 bar/ 10 minutes has fixed?..Is there any specific reason?..What is the basis for that limit and how that value has come?..Plz let me know…


Hi there

Basically there must be a tolerance on every paramenter you use in order that things can be made at an acceptable cost. Generally the tighter the parameter tolerances the higher the costs.

So the acceptable tolerance has to be developed and the rationale for that can; at times, be long and drawn out. If you go to: < Ensure your Autoclave Validation is cGMP Compliant.> the justifications for autoclave temperarue and pressure parameters are fully discussed.

Alex Kennedy

Dear nitin,

As per EN285 the limit is 1.3 bar/min as you are holding the vacuum for 10min it is 0.013 bar/10 min. There is no specific basis. please check EN285 caluse 8 and 20