Evaluating Pharmaceutical Container Closure Systems

The use of qualitative and quantitative methods can help packaging professionals determine the prese......

Single-Use (SU) Container Closure Integrity (CCI)

Regulatory & Industry Requirements
SSB Position Statement on SU-CCI
Quality Risk Management, Pro......

Role of packaging material on Pharmaceutical product stability

AgendaƒGeneral Overview ¾What is packaging? ¾Importance of packaging ¾Functions of packaging ¾Materi......

容器密闭完整性检测（CCIT）的“精度”与“精度”选择

导言
很多用户在选择设备的时候对设备的精度有比较高的要求，并且在验证的时候要求达到该要求，这对于具有度量衡资质的设备来说直接测量轻而易取；而对于某些密封性检测设备而言，如真空衰减法、压力衰减法等，这......

Understanding Container Closure Integrity Testing

Understanding container closure integrity systems, reviewing past observations, and following the re......

基于USP<1207>39中关于真空衰减法的描述与应用详解

真空衰减法原理简介：

“对放置样品的密闭测试腔抽取真空，达到稳定状态后观察真空度的变化，若真空度的变化值小于设定的阈值，或比对值小于设置的参数，则样品包装视为合格；若真空度的变化值大于设定的阈值......

Selection of Containers/Closures for Use in Lyophilization Applications: Possibilities and Limitations

Abstract
The unit operation of freeze-drying is commonly employed in the pharmaceutical industry t......

基于USP<1207>39中关于压力衰减法的描述与应用详解

压力衰减法原理简介：

“对放置样品的密闭测试腔体施加一定的气体压力，达到稳定状态后观察测试腔体内压力值的变化，若压力值的变化值小于设定的阈值，或比对值小于设置的参数，则样品包装视为合格；若压力值......