Volume 28, Number 6
by Xiaogang Pan, Xiangning Deng, Michael Lee, Thomas O, Edwin Torres, Adrian Distler, Narinder Singh
This article presents a science-based strategy to evaluate the suitability of Electron Beam (E-Beam) sterilization technology for the filling of protein-based products in Pre-Filled Syringes (PFS).
by Hisao Takahashi, Hiroshi Sakai, Daniel H. Gold
This case study will review the main items of a decontamination protocol for the renovation of a beta-lactam production facility into a non-beta-lactam production facility.
by Stan Newberger, Trish Melton
This White Paper presents the Briefly Exposed (Briefly Open) concept in the context of Intermediate and API processing based on adopting a risk-based approach as outlined in the API Baseline® Guide.
by Hari Floura, John Kremer
This article presents a performance verification study of a downflow booth via surrogate testing.
NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © ISPE. All rights reserved.)