A Road Map for the Implementation of Single-Use Technology

The growth of single-use technology (SUT) has revolutionized the bioprocess industry. The implementation of single-use technology (SUT) has typically been a trial and error exercise for the end users. A publication that provides a road map for implementation of single-use technology (SUT) into manufacturing processes was needed. The main objective of the ISPE Good Practice Guide: Single-Use Technology (GPG SUT) is to provide the ability to plan, anticipate, and respond to surprises that can arise when implementing this new technology.

ISPE’s Disposables Communities of Practice (CoP) took on this challenge that began with an initial collaboration with the sister Biotechnology Communities of Practice. The Disposables CoP assembled a group of subject matter experts (SME) in the field of single-use technology (SUT). These experts have been, and are, involved with single-use technology (SUT) in various roles and represented suppliers, engineering companies and end-users. Getting agreement from such a varied group of experts sometimes resulted in exciting discussions. These discussions led to negotiated compromises that represent a balanced approach to the implementation of single-use technology (SUT).

The ISPE Good Practice Guide: Single-Use Technology is structured with two major sections. The first major section targets the selection of components and the design of assemblies/systems. The activities that should be followed are described in this section and if completed in the order shown in the guide, they lead to an efficient and effective process. This includes:

1. The selection of components with the design of assemblies and systems
2. The quality requirements for single-use technology (SUT) equipment
3. How to assess supplier quality and define the criteria for audits
4. How to develop the user requirements specifications (URS)

The second major section deals with implementation and use. Complementary and aligned with the first section, the order of execution of these activities in this section is also critical to successful implementation. This includes:

1. The regulations typically applicable with processes using single-use technology (SUT)
2. Training programs and when to apply them during the implementation process
3. The criteria that leads to a robust and reliable supply chain

The guide includes several specific chapters and appendices that contain tools to support the two main sections. The reader will find detailed guidance on:

1. The evaluations of extractables
2. The criteria to evaluate and apply in a risk assessment
3. The overall implementation schedule and detailed schedules for specific activities

There are charts, matrices, and templates throughout the guide that can be used immediately in the implementation process. These tools help the user put into practice the guidance for what needs to be done today with a view on the end-state of the implementation program.

While the guide covers aspects across the entire implementation program to yield an efficient process, the individual sections can be used to improve a specific portion of the implementation to make it more effective. The guide targets to provide the user an implementation of single-use technology (SUT) program that is done right the first time, is on schedule and results in minimal surprises.

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