PT  - JOURNAL ARTICLE
AU  - U. Meissner
AU  - Harald Stahl
AU  - D. Steinkellner
TI  - Detection of Silicone Oil Leakages in Freeze Dryers
AID  - 10.5731/pdajpst.2011.00748
DP  - 2011 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 481--485
VI  - 65
IP  - 5
4099  - http://journal.pda.org/content/65/5/481.short
4100  - http://journal.pda.org/content/65/5/481.full
SO  - PDA J Pharm Sci Technol2011 Sep 01; 65
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.