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How to keep quality control (QC) independent from production in the move to real-time testing

How to keep quality control (QC) independent from production in the move to real-time testing

This paper has been written to address the compliance challenges of RTRT and the continued compliance with GMP standards.  To evaluate these challenges, we have reviewed the current quality guidelines that apply to RTRT and considered the areas and activities that will be impacted by an RTRT process.

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BioPhorum environmental sustainability roadmap 2022

BioPhorum environmental sustainability roadmap 2022

Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health. The healthcare sector is responsible for 4–5% of global emissions, more than 70% of which are driven by supply chains.

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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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