Dear all
The door of lyophilization is included within the class 100 clean booth. Maybe the particle will enter the chamber when we transport the partially stoppered containers to the lyophilizer.
Is it necessary to take the test?
thanks!
no not necessary, particle count study is not required for the inside area of the equipments. If any equipment having filters, needs filter integrity check and velocity check.
Ex: r u doing particle counts in autoclave which opens into sterile area…!
Hope it is helpful