WebThis study is the first to provide a systematic comparison of four commonly used physical CCIT (pCCIT) methods [Helium (He) leak, vacuum decay, laser-based headspace … WebThe industry approach to container closure integrity testing (CCIT) has indeed changed over the last 50 years, driven by concern for patient safety. A significant change, beyond just the development of CCIT methods, has been a more holistic approach toward prevention of container closure integrity (CCI) issues.

Dye Ingress Methods for Container–Closure Integrity

WebContainer Closure Integrity Testing Method requires the creation of positive and negative controls, taking into consideration the design, material, expected package leak features … WebThere is an active campaign to understand all the dynamics and implications of deploying a CCIT method. The transition to a deterministic test method for high risk CCI applications is a matter of common-sense patient safety. The August 2016 revision of the United States Pharmacopeia (USP) chapter 1207 “Package Integrity Evaluation—Sterile ... switch_rtp_request_port

Why Industry Cannot Just “Move Away" from the Dye Ingress …

WebFeb 25, 2024 · CCIT in support of container closure system (CCS) development, process validation activities or stability testing are also out of scope. This industry group considers that a holistic approach 3,4 is … WebThe team considers that the most important factor of any test method is not whether a CCIT method is ‘preferred’ but whether it is well developed, qualified and fit for its intended purpose. It says that although the method is not always product- or container-compatible, where appropriate, dye ingress continues to provide container assurance. WebCCIT, PTI’s European Headquarters is a full service, sales & support center for PTI Inspection technology solutions as well as a laboratory and demonstration facility. Our … switch rts游戏