There are many requirements (quality, regulatory, technical) that have to be met when designing new single-use systems. Following industry standards, such as ASTM E3051, BioPhorum and BPSA have created templates to walk end-users and suppliers through the SU design process. Templates for download as part of the Toolkit cover Single-Use User Requirements (SUUR), Technical Diligence and Supply Chain.
Introduction
- Purpose: The Single-Use User Requirement (SUUR) Toolkit is for the design and qualification of single-use systems (SUS).
- Components:
- User Requirements Template: Facilitates clear communication of process/application needs and supplier capabilities.
- Supply Chain Template: Enhances transparency and risk management of the SUS supply chain.
- Technical Diligence Template: Provides detailed, pre-populated forms for assessing supplier responses.
Benefits
The SUUR Toolkit offers benefits in terms of quality, cost, and delivery:
- Reduction in Full-Time Equivalent (FTE) hours.
- Decrease in churn and waiting times.
- Reduction in rework and time to production.
- Error reduction and risk mitigation.
- Standardized workflow and faster decision-making.
- Integration of industry standards.
Industry Feedback
Feedback from industry professionals emphasizes:
- Reduced compliance risks and project timelines.
- Accelerated delivery and cost savings.
- Standardized and structured communication between users and suppliers.
The SUUR Toolkit offers a transformative approach to the design and implementation of single-use systems, enabling improved communication, risk mitigation, and efficiency. By standardizing workflows and aligning user requirements with supplier capabilities, it reduces compliance risks, saves time, and minimizes resource use. The collaboration between industry experts ensures the toolkit’s credibility and adaptability, making it a vital resource for streamlining processes and achieving better outcomes in single-use system projects.