title: Detection of silicone oil leakages in freeze dryers.
abstract: 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.
  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.
authors.affiliation: MKS, Munich, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Meissner
authors.forename: Harald
authors.initials: H
authors.lastname: Stahl
authors.forename: D
authors.initials: D
authors.lastname: Steinkellner
mesh_terms: D002626:Chemistry, Pharmaceutical; D004340:Drug Contamination; D005612:Freeze Drying; D006801:Humans; D004364:Pharmaceutical Preparations; D012827:Silicone Oils; D013678:Technology, Pharmaceutical
chemical_list: D004364:Pharmaceutical Preparations; D012827:Silicone Oils