RT Journal Article
SR Electronic
T1 A Model for the Effect of Real Leaks on the Transport of Microorganisms into a Vacuum Freeze-Dryer
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 22
OP 25
VO 44
IS 1
A1 Jennings, Thomas A.
YR 1990
UL http://journal.pda.org/content/44/1/22.abstract
AB 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 process. The model considers the entry of microorganisms to result from real leaks stemming from an environment containing a known bioburden. A means for determining the relationship between the rate of pressure rise of the system (ROR) and the density of microorganisms in a system, stemming from an environment of a known bioburden, is examined. The model also considers the change in the bioburden of the dryer with respect to variations in the primary and secondary drying processes.