IMA Life North America Inc., Tonawanda, NY, USA.
Pharmaceutical R&D, Pfizer Inc., Andover, MA, USA.
Eur J Pharm Biopharm. 2018 Jun;127:298-308. doi: 10.1016/j.ejpb.2018.02.036. Epub 2018 Mar 1.
Mass Spectrometry has commonly been used in the semi-conductor industry where maintaining a clean environment with minimum contaminants under high vacuum is crucial for successful manufacturing. Since the technology's early usage for pharmaceutical manufacturing in the 1980 s, particularly in the freeze-drying environment, much has changed. The focus of the current work is aimed at asking some key questions regarding the maturity of the technology, its challenges and importance of having an application-specific instrument for quantitative process analyses applied to freeze-drying. Furthermore, we compare the use of mass spectrometers in early installations from the '80s with recent experiences of the technology in the production and laboratory environments comparing data from different MS technologies. In addition, the manuscript covers broad application of the technology towards detection of and sensitivity for analytes including silicone oil and Helium. It also explores the option of using MS in detecting water vapor and nitrogen concentration not just in primary drying, but also in secondary drying. The technology, when purpose built, has the potential for use as a robust, multi-purpose PAT tool in the freeze-drying laboratory and production environments.
质谱分析技术在半导体行业中得到了广泛应用，在高真空环境下保持清洁、最小限度的污染物是成功制造的关键。自 20 世纪 80 年代该技术首次应用于制药生产以来，特别是在冷冻干燥环境中，情况发生了很大变化。目前工作的重点是提出一些关于技术成熟度、挑战以及为冷冻干燥定量过程分析应用专门设计仪器的重要性的关键问题。此外，我们将 80 年代早期安装的质谱仪与目前生产和实验室环境中的技术经验进行了比较，比较了不同 MS 技术的数据。此外，本文还广泛探讨了该技术在检测和分析物（包括硅油和氦气）灵敏度方面的应用。它还探讨了在主干燥和次干燥过程中使用 MS 检测水蒸气和氮气浓度的选择。如果专门设计，该技术有可能成为冷冻干燥实验室和生产环境中强大的、多用途的 PAT 工具。
