Headspace Moisture Mapping and the Information That Can Be Gained about Freeze-Dried Materials and Processes [0.03%]
关于冷冻干燥材料和工艺的 Headspace 水分分布及可获取的信息
Isobel A Cook,Kevin R Ward
Isobel A Cook
Regulatory authorities require proof that lyophilization (freeze drying) cycles have been developed logically and demonstrate uniformity. One measure of uniformity can be consistency of residual water content throughout a batch. In primary ...
Root Cause Investigation of Rubber Seal Cracking in Pre-filled Cartridges: Ozone and Packaging Effects [0.03%]
预填充注射器中橡胶密封圈开裂的原因研究：臭氧和包装的影响
Edwin K Chan,Aaron Hubbard,Chung C Hsu et al.
Edwin K Chan et al.
Pre-filled syringes/cartridges as primary packaging for parenterally delivered biopharmaceutical liquids consist of multiple components, including containers made of glass or plastic, and stoppers/plungers and disk seals (septa) made of rub...
Iontophoretic delivery of acyclovir: intradermal drug monitoring using microdialysis and quantification by skin extraction [0.03%]
离子导入递送阿昔洛韦：使用微透析进行药物皮下监测及通过皮肤萃取法进行量化分析
Srujana Siddoju,Vishal Sachdeva,Phillip M Friden et al.
Srujana Siddoju et al.
The objective of this study was to investigate the effect of iontophoresis on the intradermal and transdermal delivery of acyclovir using hairless rat skin on a vertical Franz diffusion cell. In this study, cathodal iontophoretic delivery o...
Welcome to the iPDA! [0.03%]
欢迎使用iPDA！
Govind Rao
Govind Rao
An improved method for visualizing the morphology of lyophilized product cakes [0.03%]
一种改善冷冻干燥产品饼形貌可视化方法的新方法
Philippe Lam,Thomas W Patapoff
Philippe Lam
Due to low optical contrast, the morphology of lyophilized product cakes is difficult to observe and photograph. Furthermore, internal structures are normally not visible unless the cake is fractured. Because most lyophilized substances are...
Comparison of deterministic and stochastic simulation for capacity extension of high-purity water delivery systems [0.03%]
高纯度输水系统容量扩展的确定性与随机仿真比较研究
Frank Riedewald,Edmond Byrne,Kevin Cronin
Frank Riedewald
This work presents a deterministic and a stochastic model for the simulation of industrial-size deionized water and water for injection (DI/WFI) systems. The objective of the simulations is to determine if additional DI/WFI demand from futu...
Tim Sandle
Tim Sandle
Cleanroom microflora are of importance for microbiologists and quality control personnel in order to assess changes in trends. Shifts in the types of microflora may indicate deviations from the "norm" such as resistant strains or problems w...
A method to quantitatively define and assess the risk of cosmetic glass defects on tubing glass vials [0.03%]
一种量化定义和评估化妆品玻璃瓶缺陷风险的方法
April W Loui
April W Loui
The pharmaceutical and biotechnology industries have long been challenged with setting appropriate cosmetic defect size acceptance criteria on glass vials. Limits are rarely data-driven and scarce information is available on defect survivab...
Carrier tests to assess the effective sporicidal concentration of a liquid chemical disinfectant for a sanitization program [0.03%]
用于消毒计划的液态化学消毒剂有效孢子杀菌浓度的载体检测方法
Stefano Ceccanti,Simona Giampieri,Susi Burgalassi
Stefano Ceccanti
The aim of the present investigation was to evaluate the microbial efficacy against highly resistant bacterial spores on different substrates using the lowest effective concentration of a market liquid sporicide based on peracetic acid. The...
Investigating Liquid Leak from Pre-Filled Syringes upon Needle Shield Removal: Effect of Air Bubble Pressure [0.03%]
预填充注射器针头护帽取出时液体泄漏的调查：气泡压力的影响
Edwin Chan,Yuh-Fun Maa,David Overcashier et al.
Edwin Chan et al.
This study is to investigate the effect of headspace air pressure in pre-filled syringes on liquid leak (dripping) from the syringe needle upon needle shield removal. Drip tests to measure drip quantity were performed on syringes manually f...