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CRB subject matter experts author Biophorum Process Closure Playbook

Dec 28, 2023

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Process Closure Playbook

The integration of closed systems in biologic facility design presents a promising avenue for innovation by minimizing the need for stringent environmental control. Despite the longstanding availability of closed systems technology, the evolution of facility design has not kept pace. Designs centered on closed systems within controlled but not classified spaces offer expeditious and cost-effective construction, fostering heightened patient protection and superior product quality.

Addressing this need for cohesive guidance, the BioPhorum closure playbook has been crafted to facilitate informed decision-making during the design, construction, or modification of biomanufacturing facilities or processes. This playbook aligns with globally recognized terminology and emphasizes adherence to current US FDA guidance, particularly focusing on baseline definitions related to system closure.

At its core, the playbook advocates for a risk-based approach to identify critical facility and process attributes and controls.

These include room classification, viral segregation, gowning, cleaning, environmental monitoring, and sampling. By adopting a risk-based methodology, the playbook acknowledges that the environment surrounding a process is just one layer in a series of protective measures contributing to overall product quality and, consequently, patient health. This approach enables companies to incorporate recent strides in process closure technologies—such as single-use bags, connectors, filters, and assemblies—within an industry-recognized framework, fostering the evolution of biomanufacturing practices.

Below you can download the first two chapters of the Closure Playbook.  

Introduction

Chapter 2: Closure Playbook – regulatory considerations – authored by David Estape

Subsequent chapters will be published throughout 2024 and will include the general philosophy of closed systems, standard terminology, and how to apply the risk assessment model.