Ebeam Technology - Transfer Technology for Pre-Sterilized RTU Components [0.03%]
电子束技术-预消毒即用型组件的转移技术
Manfred Holzer
Manfred Holzer
With increased demand on sealed packed, pre-sterilized ready-to-use (RTU) components like Syringes & Vials, the ebeam technology is used as transfer technology with surface decontamination for transfer of the RTU in a GRADE A environment li...
A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management [0.03%]
人工智能与机器学习在产品生命周期管理中的应用综述
Maria Ana Martins da Cruz Borges Batalha,Daniel Alexandre Marques Pais,Rui Alexandre Estrela de Almeida et al.
Maria Ana Martins da Cruz Borges Batalha et al.
The pursuit of harnessing data for knowledge creation has been an enduring quest, with the advent of machine learning (ML) and artificial intelligence (AI) marking significant milestones in this journey. ML, a subset of AI, emerged as the p...
Impact of Dimensional Variability of Primary Packaging Materials on the Break-Loose and Gliding Forces of Prefilled Syringes [0.03%]
预填充注射器的初级包装材料尺寸变化对其解脱力和滑动力的影响研究
Ramadan Alkeefo,Christian Hotz,Daniel Kolacyak
Ramadan Alkeefo
A prefilled syringe (PFS) should be able to be adequately and consistently extruded during injection for optimal safe drug delivery and accurate dosing. To facilitate appropriate break-loose and gliding forces (BLGFs) required during inject...
James Agalloco
James Agalloco
This publication reviews the background that shaped the execution of moist heat for terminal sterilization across the global healthcare industry. Despite the clear benefits to patient safety afforded by terminal treatments, narrow regulator...
A Strategic Guide to Improve and De-Risk Vaccine Development: CEPI's CMC Framework [0.03%]
提高和降低疫苗开发风险的策略指南：CEPI的CMC框架
Anna Särnefält,Ranna Eardley-Patel,Diletta Magini et al.
Anna Särnefält et al.
The Coalition for Epidemic Preparedness Innovations (CEPI) has developed a robust CMC (Chemistry, Manufacturing, and Controls) Framework to enhance the likelihood of successful vaccine development. This Framework serves as a comprehensive g...
Comparing Container Closure Integrity Test Methods-Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls [0.03%]
容器密封完整性测试方法的比较-使用阳性对照品考察顶空二氧化碳分析与氦检仪漏气检测的性能表现
Christian Proff,Ken Victor,Allison Alix Caudill et al.
Christian Proff et al.
As described in USP , the deterministic leak test methods using laser-based gas headspace analysis and helium leakage are those with the highest sensitivities. As stated in the chapter, "no single package leak test or package seal quality t...
Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results [0.03%]
巴西生物制药厂菌落概况定性定量分析：结果分类和管理标准
Josiane M V Mattoso,Luciana V Costa,Bruna A Vale et al.
Josiane M V Mattoso et al.
Microbiological contamination may cause microbial proliferation and consequently additional problems for pharmaceutical companies through production stoppage, product contamination, investigations of process deviations, out-of-specification...
A Holistic Approach for Fill volume Variability Evaluation and Control with Statistical Tool [0.03%]
基于统计方法的填液量变差评价及控制方法研究
Mingyang Hei,Qingqing She,Quanmin Chen et al.
Mingyang Hei et al.
Vial and syringe filling by peristaltic pump has been widely implemented by contract manufacturing organizations and biopharmaceutical companies. Fill volume is commonly considered as critical quality attribute related in aseptic filling pr...
Challenges and solutions to manufacturing of low viscosity, ultra-high concentration IgG1 drug products: From late downstream process to final fill finish processing [0.03%]
低粘度超浓IgG1型药物制剂的制造挑战及解决方案：从后期下游工艺到最终填充加工过程中的挑战与应对方案
Vaibhav D Deokar,Alok Sharma,Volety Mallikarjun Subrahmanyam
Vaibhav D Deokar
Challenges in manufacturing of high concentration antibody formulations have seldom been discussed. These are observed mainly form late downstream operations where antibody gets concentrated to its final strength, to final fill finish proce...
Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments [0.03%]
表征可提取物和浸出物的化学空间以支持计算毒理学危害评估
Candice Johnson,Arianna Bassan,Doug Kiehl et al.
Candice Johnson et al.
This article describes the development of a representative dataset of extractables and leachables (E&L) from the combined Extractables and Leachables Safety Information Exchange (ELSIE) Consortium and the Product Quality Research Institute ...