samedan logo
 
 
spacer
home > pmps > winter 2020 > the landscape for single-use systems
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

The Landscape for Single-Use Systems





Single-use technology, often described as single-use systems (SUS) or single-use equipment, has the potential to transform pharmaceutical manufacturing by offering tremendous opportunities to reduce cost, improve flexibility or cycle time, and shorten the time needed to build a manufacturing process for new, life-saving drugs. Their adoption offers numerous advantages for greater efficiency and productivity in applications such as final filtration, mixing, and aseptic connections. SUS can reduce capital investment in facilities and equipment, eliminate the need for cleaning procedures and their required validation, reduce start-up times, and decrease the risk of cross-contamination.

However, this success is very much dependent on how effectively the industry approaches the development and implementation of single-use technology. Ultimately, a new drug can only be successful if it is effective, safe, and available. Traditionally, only a comprehensive understanding of the drug product and manufacturing process can achieve these goals. This remains true as SUS is introduced in place of traditional reusable equipment. Encouraging an open science and risk-based dialogue during supplier audits and evaluation of SUS supply chains significantly improves SUS implementation (1).

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
2
     

There are no comments in regards to this article.

spacer
About the author


Jessica Shea is responsible for Extractables and Leachables Global Technical Support at Merck. Previously, she was the Manager of the E&L laboratory for the BioReliance® Validation Services. She has more than 12 years of E&L experience, including method validation, designing of custom testing, and interpreting industry and regulatory guidance.
Print this page
Send to a friend
Privacy statement
News and Press Releases

Sartorius to Join the DAX Blue Chip Index

September 4, 2021 – The life science group Sartorius will be admitted to the German DAX blue chip index. After the market closes on September 17, 2021, Sartorius preference shares will be included in the calculation of the DAX, as Deutsche Börse announced on Friday evening.
More info >>

White Papers

Personalised Medicine - Pharma and Dx Firms Share Wider Horizons

DiagnostikNet-BB

Personalised medicine might be a popular catch-phrase at the moment, but the term often causes confusion, as there is still no uniform definition for it. The expression can include areas as diverse as the measurement of individual risk, early detection using biomarker testing, stratification of patients suffering from a disease and predictions about its course.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement