Single-use technologies have become integral to modern biopharmaceutical manufacturing, supporting faster, more flexible production in an increasingly complex regulatory landscape. As adoption accelerates, the need for clear, consistent communication between end-users and suppliers has never been more critical. Yet effectively communicating single-use system (SUS) requirements remains a challenge across the industry, often revealing gaps in expectations between end-users and suppliers.
We wanted to equip the industry with common tools to enable clear and consistent communication of user requirements and supplier capabilities in accordance with industry standards. BioPhorum, in collaboration with the BPSA, has therefore published an updated edition of the Single-Use User Requirements (SUUR) Toolkit – Implementation & Use. This update reflects both current regulatory expectations and the practical experience gained since its original release in 2019.
The Toolkit is a collection of standard templates to support SUS design and qualification, facilitating right-first-time implementation. It includes a user requirements template, supply chain memo template and a supporting ‘how to’ and implementation guide. It equips the industry with common tools to enable clear and consistent communication of user requirements and supplier capabilities when building SUS for an end-user application.
SUURs allow end-users to communicate process/application details and single-use requirements to suppliers, and allow suppliers to affirm or describe their capabilities to meet these requirements. The Toolkit uses consistent terminology in a logical structure of simple, categorized requirements.
The supply chain memo template is an additional, optional template that allows end-users to communicate requests for supply-chain-related information at the component level to suppliers, providing transparency of the supply chain for a SUS and enabling understanding and management of risk.
So what is new and why does it matter?
- The updated guidance is now aligned with ASTM E3051-25, EU GMP Annex 1 and BPSA Quality Test Matrices
- It contains practical, step-by-step recommendations for implementing SUURs across organizations and supply chains
- It has an expanded focus on cross-functional engagement between manufacturing, quality, engineering, sourcing and suppliers
- It contains clear guidance on how to use the SUUR template and optional supply chain memo to improve transparency, reduce rework and accelerate ‘right first time’ execution
- It includes real-world considerations for rollout, governance and change management.
The SUUR Toolkit adds significant value to the industry by establishing a common language and a structured approach for defining requirements and confirming supplier capabilities. This reduces misalignment, mitigates risk and supports faster, more robust implementations of SUS.
For end-users, the Toolkit minimizes non-conformances and regulatory risks caused by gaps in expectations with suppliers. It also reduces implementation timelines for new designs, minimizes supply disruptions, and facilitates second sourcing by comparing supplier responses like-for-like.
For suppliers, the Toolkit deepens the understanding of customer application and requirements up front, ensuring that designs are fit for use. It also provides consistency in the content and format of user requirements, reducing the time and resources required to respond by preparing standard responses in advance.
Developed collaboratively by end-users and suppliers, this update reinforces SUURs as a foundational best practice for designing, qualifying and implementing SUS in today’s regulatory and supply-constrained environment, and will help drive consistency, transparency and confidence across SUS design and supply.
Click here to download the new SingleUse User Requirements (SUUR) Toolkit – Implementation & Use
