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Poster Presentations
Day 1, June 22（Sun.）
Room P (Maesato East, Foyer, Ocean Wing)
- 1P-PM-01
Development of silicone oil detection method in pharmaceutical freeze dryer using EI-QMS with pulsed gas injection system
(1ATONARP INC., 2Osaka Univ.)
oKozue Asakura1, Hirofumi Nagao1,2
In pharmaceutical applications, silicone oil is often used as a heat transfer fluid in the shelves carrying the drug vials. Due to the high pressure and temperature excursions freeze-dryers are subject to during the manufacturing process, silicone oil leaks can develop. In such a scenario, large batches of contaminated products are scrapped, leading to financial losses. Therefore, pressing needs are for sensors capable of detecting traces of silicone oil in time.
Quadrupole mass spectrometers using electron ionization (EI-QMS) such as ASTON are known to detect traces of silicone oil down to low ppm levels. However, prolonged exposure to traces of silicone oil has a deleterious effect on the health and performance of the EI-QMS sensor. To use EI-QMS as an effective real-time continuous monitor of silicone oil, we have developed a pulsed gas injection device and method.
The pulsed gas injection system can be optimized to minimize the exposure to silicone oil vapors during a given freeze-drying process, and does not interfere with the parallel monitoring such as endpoint detection of drying.