2011/09/01 by Uwe Meissner, Harald Stahl, D Steinkellner · 1 citation
Biochemistry, Genetics and Molecular Biology · Chemistry · Engineering · #Protein purification and stability #Analytical Chemistry and Chromatography #Analytical Methods in Pharmaceuticals #Silicone oil #Process engineering #Contamination #Computer science #Process (computing) #Biochemical engineering #Silicone #Production (economics) #Environmental science #Leakage (economics) #Risk analysis (engineering) #Pulp and paper industry #Materials science #Business #Engineering
paper · doi:10.5731/pdajpst.2011.00748
openalex publication_date 2011/09/01 · openalex created_date 2025/10/10 · openalex updated_date 2026/08/01
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.