This paper considers the nature and source of real and virtual leaks and the effects that such
leaks can have on the drying process or the product. The presence of such leaks is detected …

Freeze drying of parenteral products is becoming more prevalent in the pharmaceutical
industry. An integral part of the freeze-drying process is the vacuum system. Proper …

A scientific rationale is proposed for the establishment of acceptance criteria for leak rates in
pharmaceutical freeze dryers. A methodology has been developed to determine the …

A scientific rationale is proposed for the establishment of acceptance criteria for leak rates in
pharmaceutical freeze dryers. A method was developed to determine the quantity of air that …

This paper is a study of the composition of gases present during vacuum freeze drying. The
residual gas analyzer and its associated high vacuum system are described. Cracking …

The principal aim of this study is to extend to a pilot freeze-dryer equipped with a non-
instantaneous isolation valve the previously presented pressure rise analysis (PRA) model …

This paper proposes a model for determining the effect that real leaks, whose flow is viscous
in nature, could have on the microorganism density in a vacuum freeze-dryer during a drying …

The end point of sublimation drying, or primary drying, is an important control point in the
freeze drying process. Traditionally, the end of sublimation drying is determined by product …

The principal aim of this study was to evaluate the Pressure Rise Analysis (PRA) method as
a nonintrusive method for monitoring the product temperature during primary drying of the …

This paper demonstrates the importance of the inspection qualification (IQ). It was shown
that the facilities were adequate to house the dryer and its associated instrumentation, and …