Global Marketing

American Pharmaceutical Review

Single-Use/Disposables Technologies and Equipment Roundtable

American Pharmaceutical Review March 2019 Single-Use Roundtable

Single-Use/Disposables Technologies and Equipment Roundtable

This American Pharmaceutical Review article discusses the best practices for implementing single-use (disposable) technologies, and the consequences of understanding that as an end-user, you are effectively outsourcing functions were serviced via in-house capacity with traditional systems. The easiest processes to transition to single-use systems are highlighted with a focus on implementing best practices for integrating single-use and stainless steel equipment (hybrid systems). Predictions for the future of single-use systems are discussed. The panel includes Max Blomberg, Director of Operations, and Christian Julien, Director of Pharma Process Solutions, as well as experts from Finesse, BioPlan Associates, Pall Life Sciences, Thermo Fisher Scientific and Ulteemit Bioconsulting.

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Continuous Quality Verification

Continuous Quality Verification as a Contronl Strategy for Biocontainers

Pharmaceutical Processing: Continuous Quality Verification as a Control Strategy for Biocontainers

Continuous Quality Verification as a Contronl Strategy for Biocontainers

This Pharmaceutical Processing article discusses a fresh approach to the industry’s discussion around the need to test the integrity of single-use systems, such as biocontainers and tubing assemblies, used in the processing of biopharmaceutical solutions. The reactive approach that attempts to test quality in at the end of biocontainer manufacturing, or post assembly operations, is unlikely to become the answer when it comes to ensuring robust single-use process solutions. With the advent of the ICH Q8 guidance and ASTM E2500 much has been written about its fundamental premise of building quality into a system, i.e. Quality by Design (QbD), versus testing or inspecting it in, commonly referred to as Quality by Inspection (QbI). QbD concepts are not new and have seen tangible implementations in other process industries that require a high level of product robustness. The QbD/QbI discussion can be expanded to the manufacture of single-use products and parallels can be drawn between the control strategies utilized by single-use manufacturers and those applied by drug manufacturers. This article delves further into this approach as a strategy for ensuring quality.

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