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BioPhorum strengthens supply chain resilience through digitization of the supply chain and alternatives to gamma sterilization

Since 2016, BioPhorum Supply Partner has made great progress in bringing together manufacturers and supply partners to build modern and effective inbound supply chains and develop a program of work that addresses some key areas: risk; planning; and education, qualification and control. Its industry expertise and ‘horizon scanning’ mean its transformative program reduces risk and adds value for members. This can be seen in the creation of two...

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Isolator best practices: Benchmark and analysis

This benchmark details the current industry operating practices on gloves testing, surface disinfection and interventions in isolators. It includes the practices from 26 biopharma drug product sites from 14 member organizations. The survey has been used to share practices and consider the opportunities for joint improvement in the industry.

in more detail the survey compares glove inspection both visual and automatic integrity testing, disinfection and cleaning methods as we as the use of H2O2.  Interventions, their categorization, tracking and approval, operator qualification and the handling of door seal failures.

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Isolator glove management evaluation of regulatory guidance and framework of recommendations

The loss or delay of a batch for glove failure and uncertainties of glove management are perennial concerns for aseptic filling operations. Written by a team of industry practitioners who create, justify and manage glove programs, this guide defines current best practice and the actions we can all take to reduce risk. Specifically it enables users to understand glove-related risks, facilitating deviation investigations and building confidence when presenting to inspectors. Helps users understand the rationale for supplier recommendations about glove lifecycle management. Reduces the need for users to develop their own glove lifecycle management strategies and standardizes the language for collecting data in and across companies, that will support future benchmarking and improvement.

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URS for small flexible filler technology

As the product in company pipelines increase in number and reduce in expected patient numbers there is a need to move from large batch, high-speed lines, to agile units that can rapidly switch between products. These changes are leading to innovation and creativity from equipment suppliers, but in addition customers need more standardization and fewer proprietary systems to aid with interchangeability, reliability and unit cost reduction. To make this happen in good order users need to ask for similar capabilities, using the same language to create necessary pull to influence equipment suppliers. This URS establishes an industry benchmark of flexible filling needs and serves to streamline the acquisition and approval of new equipment by pharma company leadership. It will enable the industry to bring products to patients faster and reduced costs through use of standard components and processes. Ultimately, enabling organizations to develop small-batch capabilities in preparation for the future of personalized medicines.

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