Single-Use Systems Qualification Checklist

Component Selection and Design

Assess suitability of single-use materials.

• Are single-use components selected based on documented compatibility with the process fluid and contact conditions? *
• Are material compositions, additives, and gamma-irradiation effects documented from the supplier? *
• Is the wetted-surface-area to fluid-volume ratio considered in the risk assessment?

Chemical Compatibility and Extractables

• Are extractables and leachables studies performed or leveraged from the supplier for the specific process conditions? *
• Is a chemical compatibility assessment documented for solvents, pH extremes, and temperatures used? *
• Is the risk classification of the component (based on contact and dosage form) assigned per USP <665>? *

Physical Integrity and Particulates

• Is pre-use or post-use integrity testing defined for single-use assemblies where sterility is required? *
• Are particulate and endotoxin controls established for the single-use flow path? *
• Is bag and tubing burst or leak testing evaluated under maximum operating pressure?

Supplier Assurance and Change Control

• Is the single-use supplier qualified with an audit and a quality or supply agreement? *
• Are supplier change notifications received and assessed for impact on the qualified state? *
• Are lot-to-lot consistency and certificate of conformance requirements defined? *