首页> Journal of pharmaceutical sciences> Changing the container closure system of lyophilized products: Real or perceived risk to process efficiency and product quality?

Changing the container closure system of lyophilized products: Real or perceived risk to process efficiency and product quality?

导出 OA

翻译打印收藏纠错

第一作者： Maxwell,Korang-Yeboah

第一单位： Division of Product Quality Research V, Office of Product Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA. Electronic address: Maxwell.Korang-Yeboah@fda.hhs.gov.

作者： Maxwell,Korang-Yeboah ^[1] ; Ann-Marie,Afrifa ^[2] ; Lisa,Ma ^[3] ; Yvonne,Berko ^[4] ; Shawn,Zhang ^[3] ; Thomas,O'Connor ^[5] ; Muhammad,Ashraf ^[5]

作者单位： Division of Product Quality Research V, Office of Product Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA. Electronic address: Maxwell.Korang-Yeboah@fda.hhs.gov. ^[1] Division of Pharmaceutical Manufacturing Assessment II, Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA. ^[2] DigiM Solution LLC, Woburn, MA, USA. ^[3] Division of Product Quality Assessment IV, Offices of Product Quality Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA. ^[4] Division of Product Quality Research V, Office of Product Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA. ^[5]

关键词 AI/ML image analysis Container closure system Heat flux analyzer High resolution micro-CT analysis Lyophilization PAT Process efficiency Risk assessment Vial heat transfer