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Quality, safety, and cost benefits with BioPhorum’s supply change notification template

Supply change notifications across the biomanufacturing industry have increased significantly since the start of the pandemic due to the increased requirements for raw materials used in the vaccine manufacturing process. One BioPhorum member has reported an increase from two notifications a week to 200 a month. Unfortunately, this surge has highlighted inefficiencies in the change management process for single-use systems (SUS) and its ability...

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Boosting training in single-use technologies through vendor and end-user collaboration

Collaboration in BioPhorum can bring many benefits to member companies. There are the usual cost and schedule improvements but also the quality aspects of manufacturing biopharmaceutical products, which are shared between biomanufacturers and their supplier partners they rely on for raw materials and single-use technologies (SUTs).   This can even be seen in the area of workforce training, especially for SUTs. Making the most of these...

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Why this SUS audit guide will reduce industry’s audit burden

In 2020, BioPhorum and Rx-360™ collaborated to develop a pilot program to assess that a Joint Audit Program® model was appropriate for use when auditing suppliers of single-use systems (SUS). The pilot was deemed a success and the model was found to be transferrable across companies with potential benefits around cost, audit burden, and resources for all stakeholders. The results were published in the Joint Audit Program ® – Pilot Program...

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Single-use system audit guide

The single-use audit guide has been designed to help the auditor and auditee understand the areas of focus in SUS audits, referencing relevant requirements and SUS manufacturing ‘elements’. It is also designed to assist the auditor in reporting their assessment of SUS manufacturers to the end-user. It includes sections on general quality management system areas and products and production processes to consider. It is designed to be applicable to audits of single-use system manufacturers.

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Getting a handle on bag leakage with BioPhorum’s new toolkit

Improper handling of bags is a significant contributor to leaks in single-use systems (SUS). It regularly causes significant, often unreported, failure modes (e.g. tearing and punctures) that cause product, supply, product variability and end-user operability problems. The cost per leak – including investigations, lost time and product losses – ranges from thousands to many millions of dollars. Unfortunately, formal training methods and...

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Disposables: Single-use systems bag assembly leakage and defect toolkit

This toolkit gives users a set of tools to respond to problems and materials to include in their communications and operator training.It will help reduce product losses, investigations, manufacturing disruptions and the number of leaks. It equips industry with tools to help standardize the vocabulary around SUS anatomy and processes and expand its understanding of SUS abnormalities.

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BioPhorum’s revised and improved guidance on single-use change notifications

Changes to critical, complex systems in our regulated environments must be 100% right. This was recognized by the single-use industry and key customers some five years ago and resulted in a number of papers and much better alignment to a standard language and ways of working around single-use system change controls. However, there is always room for improvement and greater alignment in the industry, and the collective learnings have now been...

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How to bring clarity to the testing, validation and release of single-use systems

In the rapidly evolving area of single-use systems (SUSs), the testing of components is critical for process and product quality. However, industry currently faces some critical questions, such as when is it appropriate to rely on vendor testing data? And when should the end-user carry out testing? With this uncertainty also comes the question of whether current regulatory guidance is sufficient? Unfortunately, the answer to this question is...

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