RT Journal Article
SR Electronic
T1 Detection of Silicone Oil Leakages in Freeze Dryers
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 481
OP 485
DO 10.5731/pdajpst.2011.00748
VO 65
IS 5
A1 U. Meissner
A1 Harald Stahl
A1 D. Steinkellner
YR 2011
UL http://journal.pda.org/content/65/5/481.abstract
AB As a small leakage from the silicone oil tubes in pharmaceutical freeze dryers may go undetected for several cycles, it provides a major threat to both product safety and the economic performance of such installations. A properly mounted mass spectrometer offers a non-invasive method of detecting the smallest amounts of silicone oil down to 1 ppm. Additionally the system will improve leak testing procedures and can also be used as a process analytical technology tool to improve process control. LAY ABSTRACT: Drugs, and in particular parenterals, need to have a very high level of purity. A production process such as freeze drying carries the inherent risk of contamination by process fluids. This should not happen during routine production, but in the event of a malfunction small amounts of these fluids may contaminate the drug product. The purpose of this paper is to introduce a method which is able to detect such malfunctions before they can develop into a risk for drug purity and ultimately patient safety.