The principle objectives of this paper are (a), to develop the rationale for conducting an
inspection qualification (IQ) and operational qualification (OQ) of a vacuum freeze-dryer;(b) …

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 …

Design Qualification Design Qualification is the process by which it is assured that an item of
equipment, a system, or a procedure has been designed so that it will perform the tasks …

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 …

The objective of this investigation was to evaluate two methods for measuring the maximum
sublimation rate that a freeze-dryer will support—the minimum controllable pressure method …

This paper discusses the effect of pressure on the lyophilization, or vacuum freeze-drying.
process, and the various types of vacuum gauges typically used for such pressure …

Materials and methods The following equipment and materials were used: freeze dryers
(LMX33, IMA Life), hydrophobic sterilizing grade filter (Sartofluor 0.2 [micro] m, 10 in …

Best practices for performing freeze dryer equipment qualification are recommended,
focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf …

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 …

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 …