Volume 28, Number 6
Evaluation of Electron Beam (E-Beam) Sterilization Technology for Filling of Drug Products in Pre-Filled Syringes (PFS)
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).
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Case Study: Beta-Lactam Decontamination and Cleaning Validation of a Pharmaceutical Manufacturing Facility
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.
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A Risk-Based Approach to Defining Levels of Protection within API Facility Design: The Concept of Briefly Exposed (Briefly Open)
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.
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Performance Verification of a Downflow Booth via Surrogate Testing
by Hari Floura, John Kremer
This article presents a performance verification study of a downflow booth via surrogate testing.
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Online Exclusive Articles
A Regulator's Perspective of His GAMP Experience
by Anthony Trill
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Global Regulatory News
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