The BioPhorum response to the Annex XV Report on the proposal for universal PFAS restrictions. It is considered by the BioPhorum collaboration that unless ECHA provide the biopharmaceutical manufacturing industry with appropriate exemptions or derogations to find, test and validate alternatives and execute a transition out of these materials (where alternatives are available), there will be a real threat to the global availability of critical vaccines and biotherapeutics.
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How to keep quality control (QC) independent from production in the move to real-time testing
Jan 2023 | Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, POI - Regulatory, Publication, Quality Control
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Jan 2023 | Alternative and Rapid Micro Methods, Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, Publication
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Jan 2023 | Deliverable, Fill Finish, POI - Fill Finish, Publication, Visual Inspection
The intent of this paper is to illustrate that the probabilistic nature of detection is well understood and it aims to dispel the misunderstandings associated with VI through illustrated examples and by highlighting that the probabilistic nature of inspection is recognized in multiple
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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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Oct 2022 | Deliverable, Deliverables Report, Fill Finish, Publication, Visual Inspection
This member only paper explains how 100% inspection is not the same as 100% detection of defects, how VI is probabilistic in nature, how the probabilistic nature is noted is all major regulatory guidance, and explaining how probability of detection varies with a range of product and defect categories
100% misunderstanding
Oct 2022 | Deliverable, Deliverables Report, Fill Finish, Publication, Visual Inspection
This member only paper explains how 100% inspection is not the same as 100% detection of defects, how VI is probabilistic in nature, how the probabilistic nature is noted is all major regulatory guidance, and explaining how probability of detection varies with a range of product and defect categories
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Oct 2022 | Deliverable, Deliverables Report, Fill Finish, Isolator Good Operating Practice, Publication
A series of member only downloads which look at industry experiences of the BioPhorum Isolator Good Operator Practice Team
Challenges encountered in the implementation of bio-fluorescent particle counting systems as a routine microbial monitoring tool
Jul 2022 | Alternative and Rapid Micro Methods, Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, Publication
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.
ACC Technical Application
Jul 2022 | Fill Finish, POI - Fill Finish
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...