Implementation of Barrier Systems - Where is the A Team? Poster Presented at PDA Week 2025 [0.03%]
屏障系统实施-哪里有精英团队？海报在2025年PDA周上发表
Marsha L Steed
Marsha L Steed
Companies are implementing barrier systems, RABS and isolators, to align with Annex 1 requirements. The implementation of a new filling line requires a cross-functional team of highly skilled staff to ensure success. Even more critical is t...
Advancing Parenteral Package Integrity Testing: Case Studies on IV Bags and Pre-Filled Syringes: Poster Presented at PDA Week 2025 [0.03%]
parenteral包装完整性测试的进展：IV袋和预装注射器案例研究：PDA周2025会议壁报展示
Rob Zecchin
Rob Zecchin
Ensuring the integrity of parenteral drug packaging is critical for maintaining product sterility and patient safety. This poster presents case study data on two applications of non-destructive, deterministic Container Closure Integrity Tes...
Bacterial Endotoxins Testing Using Non-Animal Derived Reagents and Innovative Microfluidic Technology on Real World Samples: Poster Presented at PDA Week 2025 [0.03%]
使用非动物源试剂和创新微流控技术进行细菌内毒素检测：在PDA周2025上展示的海报研究
Hayden Skalski
Hayden Skalski
Annex 1 encourages pharmaceutical companies to adopt new and innovative technologies in order to streamline their manufacturing processes. As well, companies are continually looking to create more sustainable laboratories. Using microfluidi...
NeoFlexTM Plunger Platform: A Focus on Large Volume Plungers for Autoinjector and Wearable Devices: Poster Presented at PDA Week 2025 [0.03%]
NeoFlexTM 活塞平台：大型体积活塞在自动注射器和可穿戴设备中的应用：PDA Week 2025 展会海报内容
Yitian Xiao
Yitian Xiao
Large-volume auto-injectors and wearable devices exceeding 2.25 mL play a crucial role in the transition from hospital-based intravenous (IV) treatments to self-administrated drug delivery via subcutaneous (SC) injection. These devices are ...
The Next Step in the Journey to a Full Electronic Quality Management System (EQMS) in the Irish Blood Transfusion Service: Poster Presented at PDA Week 2025 [0.03%]
爱尔兰血液输血服务全面电子质量管理系统的下一步：2025年PDA周会议墙报展示
Rebecca Walden
Rebecca Walden
In 2024 we completed a case study outlining the development of a bespoke User Requirement Specification (URS) for a full Electronic Quality Management System (EQMS) in the Irish Blood Transfusion Service (IBTS) as part of our 2021-2025 Stra...
Defining a Generic Technology Transfer Process for use Across the Biopharmaceutical Manufacturing Industry [0.03%]
生物制药制造行业中定义通用技术转让流程
Jonathan Moore,Diana Chinchilla-Olszar,Mary Switzer et al.
Jonathan Moore et al.
The technology transfer process varies widely between organizations across the biopharmaceutical industry. This variation amplifies the complexity of transfers and negatively impacts the communication of critical information. Organizations ...
Automated Surface Swab Sampling: A Statistical Comparison of a Novel Approach to Existing Methods [0.03%]
自动化表面拭擦采样：新方法与现有方法的统计比较
Nicole Collier,Michael Lund,Keith Bader et al.
Nicole Collier et al.
Analytical testing and an appropriate sampling method are instrumental in confirming that equipment surfaces have been adequately cleaned during cleaning validation or verification activities. The sampling method is critical to generating a...
Biological Indicators, Process Lethality and Vapor Phase Hydrogen Peroxide Processes [0.03%]
生物指示剂、工艺致死量和过氧化氢蒸汽灭菌过程
James Agalloco
James Agalloco
This manuscript reviews the similarities between death curves associated with 'rogue' biological indicator results in vapor phase hydrogen peroxide decontamination / sterilization processes and those expected from varying process conditions...
Ensuring Robust Drug Delivery: A Comprehensive Study on the Mechanical and Chemical Performance of 3 ml RTU Cartridges [0.03%]
确保药物稳定输送：3毫升RTU药筒机械及化学性能全面研究
Robert Lindner,Daniele Zuccato,Volker Rupertus
Robert Lindner
Driven by more patient-centric at-home treatments, the pharmaceutical industry is shifting toward subcutaneous drug formulations, particularly for biologics. This aids in simplifying patient self-administration, improving adherence, and red...