Equipment and Process Validation for an Industrial VH2O2 Sterilization Application: Poster Presented at PDA Week 2025 [0.03%]
用于工业VH2O2灭菌应用的设备和工艺验证：在PDA Week 2025上展示的海报
Mary Van Gaasbeck Carico
Mary Van Gaasbeck Carico
Sterilization of sensitive drug delivery devices such as pre-filled syringes can be significantly enable by implementing Vaporized Hydrogen Peroxide VH2O2 (VHP) Low Temperature Sterilization for the process application. Utilizing VH2O2 has ...
A Quality by Design (QbD) Approach to Microbial Retention Validation: Poster Presented at PDA Week 2025 [0.03%]
基于质量设计（QbD）的微生物截留验证方法学研究：于2025年PDA周会议上发表的墙报展示
Annie Leahy,Jennifer Juneau,Corinne Miller et al.
Annie Leahy et al.
Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to microbial retention testing supports a paradigm that would...
Regulatory Data Insights and Methods of Extraction and Analysis: Poster Presented at PDA Week 2025 [0.03%]
监管数据洞察及提取与分析方法：于2025年PDA周会议展出的海报内容
George Kwiecinski,Zephaniah Odidika
George Kwiecinski
This study investigates trends in FDA warning letter issuance between 2019 and 2023, focusing on the agency's efficiency and evolving priorities during this period. By analyzing both quantitative and qualitative data, the research highlight...
Effect of Lyophilization on the Concentration and Recovery of Potential Leachables in Different Matrices Simulating Biological Media: Poster Presented at PDA Week 2025 [0.03%]
冻干对不同基质中潜在浸出物浓度和回收率的影响：于PDA周2025会议上发表的墙报研究
Gisele Abreu Coelho
Gisele Abreu Coelho
Detecting migrant compounds from pharmaceutical packaging and medical devices is crucial for patient safety. Lyophilization, often used to enhance detection limits by removing water and concentrating analytes, may cause analyte losses. This...
A Novel Automated Approach to Surface Swab Sampling: Poster Presented at PDA Week 2025 [0.03%]
一种新颖的自动化表面擦拭取样方法：在PDA周2025会议上展示的海报
Keith Bader,Richard Mineo,Nicole Coller et al.
Keith Bader 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. Surface swab sampling is performed manually by ...
Ebeam Technology - Annex 1 Compliant Transfer of Ready To Use Objects: Poster Presented at PDA Week 2025 [0.03%]
电子束技术-附录1合规的即用型对象转移：在2025年PDA周上展示的海报
Merritt Postma
Merritt Postma
With increased demand on sealed packed, pre-sterilized ready-to-use (RTU) components like Syringes & Vials, the ebeam technology is used as Annex 1 compliant transfer technology with surface sterilization for transfer of the RTU to higher g...
Next GEN Pharma Machinery - Flexible Fill and Finish: Poster Presented at PDA Week 2025 [0.03%]
下一代制药机械柔性填充与 finishing：在PDA周2025上展示的海报
Juergen Metzger
Juergen Metzger
The pharmaceutical industry is constantly evolving, driven by technological innovations aimed at enhancing efficiency, quality, and adaptability in drug manufacturing processes. This presentation highlights the success story of flexible fil...
International Technology Transfers: A Playbook for Success: Poster Presented at PDA Week 2025 [0.03%]
国际技术转让：成功攻略：在PDA周2025上展示的海报
Priscilla Pingrey,Teresa Henry,Liza Lamb et al.
Priscilla Pingrey et al.
The BIOSECURE Act, along with the recent election, stands to influence the reshoring of biomanufacturing activities in the United States, significantly impacting the growth of international technology transfers. However, these technology tr...
Material and Packaging Selection and Compatibility with Chlorine Dioxide Gas Sterilization: Poster Presented at PDA Week 2025 [0.03%]
二氧化氯气体灭菌过程中的材料、包装选择及兼容性研究 poster presented at pda week 2025
Emily Lorcheim
Emily Lorcheim
Chlorine dioxide gas (CD) sterilization is an alternative modality to ethylene oxide as well as other sterilization modalities and is of high interest to the EPA and FDA due to both its sustainability as well as effectiveness. The dry metho...
High-Speed Radiographic Analysis of Subcutaneous Injection Depots: Dispersion, Morphology, and Diffusion in Autoinjector Delivery: Poster Presented at PDA Week 2025 [0.03%]
高速放射性分析皮下注射剂型：自动注射器递送中的分散、形态和扩散：2025年PDA周会议壁报
Rozhin Derakhshandeh,Jean-Christophe Veilleux,Galen H Shi et al.
Rozhin Derakhshandeh et al.
Autoinjectors facilitate self-administration of subcutaneous (SC) medications. Despite their benefits for patients and healthcare systems, experimental research on how they impact drug dispersion and absorption is limited. This study invest...