Introduction to CCI Testing for Freeze-Dried Products

Introduction to CCI Testing for Freeze-Dried Products
Ability of a container closure system (CCS) to maintain the sterility and product
quality of sterile final pharmaceutical, biological, and vaccine products
throughout their shelf-life.
CCI strategy includes different steps:

Qualification of CCS

QC sampling (Microbial Ingress Test, Blue Dye Test,…) as release
testing

QC stability testing (testing at expiry)

100% routine testing

How the adoption of Single Use systems (SUS) improves Safety, Efficiency and Flexibility of Final Filling Processes

How the adoption of Single Use systems (SUS) improves Safety, Efficiency and Flexibility of Final Filling Processes
Industry Challenges
Single Use Systems (SUS)for Final Filling operations
How SUS Improves Safety, Efficiency and Flexibility
SUS Supplier approachto enhanceprocesssafety

Standard Guide for Selection of a Leak Testing Method1

Standard Guide for Selection of a Leak Testing Method1
1.1 This guide2 is intended to assist in the selection of a leak testing method.3Fig. 1 is supplied as a simplified guide.
1.2 The type of item to be tested or the test system and the method considered for either leak measurement or location are mrelated in the order of increasing sensitivity.
1.3 This standard does not purport to address all of the msafety concerns, if any, associated with its use. It is the mresponsibility of the user of this standard to establish appropriate msafety and health practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2019 PDA Pharmaceutical Product Quality Testing Conference

2019 PDA Pharmaceutical Product Quality Testing Conference
A recent article in the PDA Letter (1) argued that the pharmaceutical industry should stop using the ubiquitous dye ingress test. The authors of this response would like to present an alternative view—that the industry should not limit its testing options if those extensively used and accepted methods are still useful and appropriate tools for ensuring patient safety

Liquid Immersion Microbial Challenge Tests: Microbial Testing for Container Closure Integrity

Liquid Immersion Microbial Challenge Tests: Microbial Testing for Container Closure Integrity
Introduction
The container closure system for pharmaceutical products intended to be sterile is critical and this criticality relates to the physical properties of the container closure system in that a poorly designed or manufactured system will result in microbiological penetration. Factors to take into account with, for example, rubber-stoppered glass vials include having the correct dimensional specifications for the internal diameter of the neck opening and its depth, the internal and external diameters of the flange. Other factors are the concentricity of the flange, the neck and the body of the vial. Any angularity of the flange versus the vertical center line of the vial must be specified; so must the physical finish of the surface of the flange and internal neck bore to ensure satisfactory mating with the closure. Closures must be specified in terms of diameters, depth, thickness and elasticity.