<br />
BioProcess<br />
International<br />
DIGITAL EDITION<br />
ARCHIVE<br />
BioProcess<br />
International<br />
SPECIAL REPORT<br />
Ensuring<br />
Single-6se Systems Integrity<br />
in Aseptic or Closed-Process<br />
Applications<br />
Ensuring Single-Use Systems Integrity in<br />
Aseptic or Closed-Process Applications<br />
Marc Hogreve, Inga Reinert, and Nathalie Pathier<br />
S<br />
ingle-use systems (SUS) have brought process efficiency, improve product quality, and help<br />
numerous benefits to biopharmaceutical ensure product availability.<br />
processes. Originally used in applications for Therefore, SUS integrity (SUSI) is a critical quality<br />
preparation and storage of buffers and media, attribute (CQA) for both end users and suppliers of<br />
SUS are being implemented increasingly in SUS. Whereas with stainless-stee<a title="January-February 2023 - Special Report - Sartorius page 1" href="https://secure.viewer.zmags.com/publication/9dbaae6f?page=1"> BioProcess International DIGITAL EDITION ARCHIVE</a>
<a title="January-February 2023 - Special Report - Sartorius page 2" href="https://secure.viewer.zmags.com/publication/9dbaae6f?page=2"> BioProcess International SPECIAL REPORT </a>
<a title="January-February 2023 - Special Report - Sartorius page 3" href="https://secure.viewer.zmags.com/publication/9dbaae6f?page=3"> Ensuring Single-Use Systems Integrity in Aseptic </a>
<a title="January-February 2023 - Special Report - Sartorius page 4" href="https://secure.viewer.zmags.com/publication/9dbaae6f?page=4"> Figure 2: Decision tree for risk assessment </a>
<a title="January-February 2023 - Special Report - Sartorius page 5" href="https://secure.viewer.zmags.com/publication/9dbaae6f?page=5"> Figure 3: SUS lifecycle example (SIT = supplier i</a>
<a title="January-February 2023 - Special Report - Sartorius page 6" href="https://secure.viewer.zmags.com/publication/9dbaae6f?page=6"> Figure 4: Sartorius's testing solutions (SIT = su</a>
<a title="January-February 2023 - Special Report - Sartorius page 7" href="https://secure.viewer.zmags.com/publication/9dbaae6f?page=7"> Figure 5: Testing options to meet different need</a>
<a title="January-February 2023 - Special Report - Sartorius page 8" href="https://secure.viewer.zmags.com/publication/9dbaae6f?page=8"> Figure 6: Pressure ranges for integrity science s</a>
<a title="January-February 2023 - Special Report - Sartorius page 9" href="https://secure.viewer.zmags.com/publication/9dbaae6f?page=9"> Figure 7: Correlation between microbial ingress a</a>