This members only document serve as a reference document on the impact of Annex 1 on CCI for existing and new workstream members and is a collation of responses surveyed, narrative and notes made during discussions between SMEs and where applicable guest speakers.
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User vision for the filling line of the future
Aug 2023 | Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, Publication
This paper from the BioPhorum Commercial Lines of the Future team provides an overview of the future needs of the industry for aseptic manufacture and will inform and assist equipment providers in developing the appropriate technology. It is divided into general and detailed requirements. The general requirements are capability and capacity, and the detailed requirements are decontamination, filling, environmental monitoring, component handling, and connectivity.
Understanding the non-equivalency of bio-fluorescent particle counts versus the colony forming unit
Jul 2023 | Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, Publication, Rapid Methods for Adventitious Agents
In this paper, published in the PDA Journal, the M3 collaboration explore the challenges presented by the Bio-Fluorescent Particle Counting (BFPC) technology, when considering that the traditional Colony Forming Unit (CFU) is the gold standard which any change is measured against. We examine why attempts to correlate newer units of measure used by Bio-Fluorescent Particle Counters, namely the Auto-Fluorescent Units (AFUs), to the traditional CFUs are not necessarily appropriate. The paper explores in depth why there is no consistent correlation factor between the two units of measure, and why that should not be a barrier to fully leveraging, implementing, and using such modern technologies in routine monitoring.
BioPhorum comments on proposed national emission standards for hazardous air pollutants ethylene oxide emissions standards for sterilization facilities residual risk and technology review
Jul 2023 | Cell & Gene Therapy, Deliverable, Deliverables Report, Development Group, Drug Substance, Feedback to agency, Fill Finish, POI - Supply Partner, Publication, Regulatory, Supply Chain to Patient, Supply Partner, Sustainability
This group supports the Environmental Protection Agency’s (EPA) efforts to protect public health and the environment through the Residual Risk and Technology Review (RTR) process and recognizes the
need to develop stringent emissions standards to mitigate any potential hazards posed by Ethylene Oxide (EtO) emissions. However, they are also cautious of the impact these changes may have on the availability and timely delivery of biotherapeutics to patients who rely on them. Biotherapeutics, including vaccines, therapeutics, and other life-saving medications, play a crucial role in improving patient health outcomes and saving lives. For the biopharmaceutical industry, EtO sterilization is a critical process used to ensure product safety and efficacy. The EtO Response team raised several concerns regarding the potential impact of the proposed rule changes on the biotherapeutics market. This document discusses the concerns.
BioPhorum response to the Annex XV report on the proposal for universal PFAS restrictions
May 2023 | Deliverable, Deliverables Report, Drug Substance, Feedback to agency, Fill Finish, POI - Supply Partner, Supply Partner, Sustainability
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.
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
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.
Rapid sterility test systems in the pharmaceutical industry: applying a structured approach to their evaluation, validation and global implementation
Jan 2023 | Alternative and Rapid Micro Methods, Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, Publication
This paper describes a systematic nine-step approach to the evaluation, equipment qualification, validation, and deployment of alternative sterility tests which can be applied by pharmaceutical companies wanting to take advantage of the numerous benefits of alternative sterility tests. Two case studies are presented to illustrate the validation and implementation approach, including statistical methods.
100% inspection does not mean 100% defect detection
Jan 2023 | Annex 1, 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
regulatory guidance documents.
BioPhorum environmental sustainability roadmap 2022
Dec 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Development Group, Drug Substance, Fill Finish, Information Technology, MediPhorum, POI - Sustainability, Publication, Regulatory, Supply Chain to Patient, Supply Partner, Sustainability, Technology Strategy
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.
Test Download
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