Risk Reduction in Single-Use Assemblies by Implementing Helium Integrity Test and a New Point-of-Use Leak Test Using Palltronic® Flowstar LGR Instrument for Critical Formulation and Filling Applications
October 18-21, 2015
This presentation will focus on challenges with implementation of single use, including robustness concerns, ensuring closures, integrity of multi-polymer systems both during manufacturing as well as at point of use. Despite numerous challenges, rapid adoption of single-use technologies still continues due its application in both more critical applications and expansion to commercial scale. More particularly, single use bioprocessing assemblies (Biocontainers and multi component single use systems) are being utilized in increasingly critical and demanding applications such as for holding and transporting sterile bulk drug substance and formulation and final filling. Therefore, potential of product loss and operator safety risk, have highlighted the necessity of single use system integrity testing in addition to robust quality by design approach.
The presentation will discuss the landscape and how a two-step approach of integrity testing for single use systems used in critical formulation and filling can be implemented both at the manufacturer site and then at end user site as a post installation and / or after use test. Data will be presented from case studies demonstrating detection of down to 5 micron defects in the case of helium integrity testing at manufacturer site and 30 micron detection using flow measurement method at end user site. We will demonstrate with the latter technology how the same test instrument can then be applied for both testing the integrity of the system and the filter, therefore reducing significantly test time for enhanced convenience.
The presentation will cover testing three different types of single use systems using flow measurement: (a) a tubing manifold assembly with no biocontainer, (b) assembly with 2D biocontainer as part of the system, and (c) assembly with 200L 3D biocontainer. The data will also be presented to demonstrate the sensitivity of flow measurement approach by introducing a calibrated leak to an integral system (Figure 1), impact of testing same system more than once, ease of use, and test duration.
For helium integrity testing, the test procedure and data on sensitivity of test in detecting defects for different size biocontainers will be presented.
Anil Kumar, Vishwas Pethe, Ralf Kuriyel, and Helene Pora, "Risk Reduction in Single-Use Assemblies by Implementing Helium Integrity Test and a New Point-of-Use Leak Test Using Palltronic® Flowstar LGR Instrument for Critical Formulation and Filling Applications" in "Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications", Ekta Mahajan, Genentech, Inc., USA Gary Lye, University College London, UK Eds, ECI Symposium Series, (2015). http://dc.engconfintl.org/biopoly/51