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Challenges encountered in the implementation of bio-fluorescent particle counting systems as a routine microbial monitoring tool

This article published in the PDA Journal of Pharmaceutical Science and Technology discusses challenges encountered when implementing bio-fluorescent particle counting systems as a routine microbial monitoring tool , and the perspective from a consortium of four industry working groups on navigating these challenges.

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ACC Technical Application

ACC Technical Application

Following A framework for the evaluation, validation and implementation of alternative and rapid microbiological testing methods, BioPhorum will publish case studies on the application of this framework. The first article of this series explores automated colony counting systems and discusses how these systems can reduce or eliminate sources of human error, provide faster and more precise detection of microbial colonies, and allow greater...

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Lyophilizer leak rate testing – An industry survey and best practice recommendation

The vacuum integrity of freeze dryers is critical for attaining adequate process control and maintaining confidence in sterility assurance which is key for the manufacture of sterile pharmaceutical products. Although discussions on the topic have been published, there is no industry standard established that is based on empirical data or that has a justifiable scientific rationale. This paper published in the Journal of Pharmaceutical Sciences provides a perspective from 14 Pharmaceutical companies on the leak rate specifications commonly used in industry. Using this information the BioPhorum team recommend a best practice for the lyophilizer leak rate test.

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Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation

Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation

This paper addresses the need for a systematic and best practice approach to the evaluation, validation and implementation of these methods related to adventitious agents testing to support the adoption of alternative adventitious agent testing (AAT) methods. A nine-step framework and common language are described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs and alternative AATs.

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Operational vision: Adoption of in-line monitoring and real-time release

Operational vision: Adoption of in-line monitoring and real-time release

Historically, the biopharmaceutical industry has relied on traditional pharmaceutical manufacturing practices to make and release products. This publication examines the future of biopharmaceutical manufacturing by presenting the vision of fully implemented in-line monitoring (ILM) and real-time release. This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.

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Line clearance risk assessment in secondary packaging areas

Line clearance risk assessment in secondary packaging areas

This document describes the basis for performing a risk assessment for line clearance (LC) activities and failures. It contains a general description about the process and a template. This template is meant to support the documentation of the assessment of risks related to the LC process in secondary packaging lines handling pharmaceutical products and combination devices.

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Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products

Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products

This paper provides a framework to support investigations related to atypical or frequently occurring particles observed during VI or related to field complaints – which require detailed and systematic assessment of risk to the quality of the batch. The proposal for a standardized risk investigation methodology outlined in this paper may support such risk assessments, where the total risk related to foreign particles is assessed by considering a variety of risk factors (type, frequency, etc.) and applying a failure mode and effects analysis (FMEA) tool to calculate a total risk-based score.

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