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.

DESIGN, CONTROL, AND MONITORINGOFSINGLE-USE SYSTEMS FOR INTEGRITY ASSURANCE

DESIGN, CONTROL, AND MONITORINGOFSINGLE-USE SYSTEMS FOR INTEGRITY ASSURANCE
The risk management plan contains four key elements – Business, Product, Operator & Environment, and Integrity. The latter involves a Quality by Design (QbD) approach including a road map of the product life cycle to identify the quality attributes that are important for the achievement of system integrity. The guide highlights the importance of a shared responsibility by the supplier and end(user in the evaluation and implementation of the plan, and gives detailed recommendations on issues relevant to system integrity such as process validation, packaging, QC testing, installation, training, etc.

Impact of Container Closure System on Freeze Drying Process.

Impact of Container Closure System on Freeze Drying Process.
Parenterally delivered drugs have gained popularity over the last decade because of their ability to act immediately, flexibility to be administered in a controlled manner and superior compliance as compared to oral medications.1 In addition, freeze dried parenterals also offer significantly improved storage stability for liquid formulations that otherwise do not offer an acceptable storage stability.