Comparison of Excipients in Approved Parenteral Products and Their Maximum Daily Exposure Values [0.03%]
已批准注射产品中的辅料及最大日暴露量的比较
Miha Homar,Špela Kalčič,Gorazd Gorup
Miha Homar
The following article analyses the excipients used in the parenteral formulations registered by the U.S. Food and Drug Administration (FDA) in the years 2011 and 2021. It adds real-word data for parenteral excipients in approved products fr...
Steven Walfish,John Duguid,Karen McCullough
Steven Walfish
The LAL test has been the "gold standard" for endotoxin testing ever since it was first published as USP Chapter in 1980. Since then, a number of innovative methods have been proposed to augment or replace the LAL test. However novel an al...
Case Study: Compatibility Testing of Pre-Filled Syringe Stopper Technology with Vaporized Hydrogen Peroxide Terminal Sterilization Process [0.03%]
案例研究：预填注射器塞与过氧化氢蒸汽终端灭菌工艺的兼容性测试
Juha Mattila,Michael Kienzle,Arja Ruley
Juha Mattila
STERIS and W.L. GORE collaborated on a case study testing the compatibility of a new prefilled syringe plunger design with VHP terminal sterilization. VHP chamber conditions require deep vacuum pulsing, which may represent challenges to pre...
Using Digital Instructions to Address on-Market Product Complaints and Improve User Experiences [0.03%]
利用数字指示解决市场产品投诉并改善用户体验
Thomas Grant
Thomas Grant
Manufacturers of medical devices are legally required to carry out post-market surveillance and respond to any on-market complaints they receive about their device. When it comes to addressing use issues experienced on market, manufacturers...
Prefilled Ophthalmic syringes - New Possibilities in Terminal Sterilization [0.03%]
预填充眼用注射器-终端灭菌的新可能性
Bernd Zeiss,Eric Offermann,Annick Gillet et al.
Bernd Zeiss et al.
In a joint study carried out by Gerresheimer, Sterigenics and Früh, it could be shown that also NO2 is well suited to terminally sterilize prefilled ophthalmic syringes. In detail 5 topics were addressed: (1) Compare EtO vs. NO2 penetratio...
Rethinking Human Factors in Obesity: Development of Simulation and Physical Test Models of Human Soft Tissue to Study Autoinjector Activation Performance [0.03%]
肥胖中的人体工学问题反思——开发人体软组织仿真模型和物理测试模型以研究自动注射器的激活性能
Eric Linvill,Chung Tsai,Paolo Ravaynia et al.
Eric Linvill et al.
Activation against a hard surface according to ISO 11608-1 is not always representative of device use on a soft injection site. A softer injection site - which is an anthropometric property found in obese patients - presents a distinct visc...
Reusable vs Single Use: what Are the Device Trade-Offs in Improving Sustainability [0.03%]
可重复使用设备与一次性设备：改善可持续性的权衡取舍
Alastair Willoughby
Alastair Willoughby
As autoinjector requirements become increasingly diverse and pharma companies look for quicker routes to market, with lower costs and improved sustainability, there is an increasing trend towards devices with a reusable element. The flexibi...
A Novel Combined Approach to Better Predict Sealing Performance of Luer Lock Connectivity [0.03%]
一种预测鲁尔锁连接密封性能的新方法
Julien Singer,Lucile Gontard,Yetirajendra Daroji et al.
Julien Singer et al.
Luer systems, for example Luer-needle hub with syringe's Luer cone tip and its Luer lock Adapter, are common interface on medical devices. One of the key questions in this application is about the safety guaranty and dose accuracy. It is th...
Laura Berardi
Laura Berardi
Cobalt (Co) alloys are used extensively in a wide range of medical devices due to their biocompatibility, durability, and properties. In 2017 the European Chemical Agency (ECHA) proposed to classify Co metal as a category 1B carcinogen (i.e...
Evaluating Unmet Needs in Large-Volume Subcutaneous Drug Delivery: US Payer Perspectives on a Novel, Large-Volume On-Body Delivery System [0.03%]
评估大容量皮下药物输送的未满足需求：美国支付方对新型大容量体外给药系统的新看法
Mehul Desai,James Kenney,Edmund Pezalla
Mehul Desai
This research sought to evaluate payer perspectives around OBDS's through semi-structured interviews with 17 US payers representing approximately 227 million covered lives. When asked about the perceived advantages of the novel on-body deli...