Prevention, Detection, and Removal of Particles
Particulates in biopharma can have negative effects on both patients and manufacturers, from delays in dosing to loss of costly resources. Given this, it is vital to keep mitigating sources such as contaminated raw materials out of production lines. According to BioProcess Online “particle contamination was the leading cause of drug recalls between 2017 and 2021, contributing to 30% of all parenteral drug-related recalls.” While these numbers sound daunting, particulate contamination is preventable. Through mitigation, prevention, and
removal approaches, you can improve the odds of having zero defects.
Featured Webinar
Featured Webinar
Product Solutions
Prevention
Selecting the right materials and optimizing processes can help prevent contamination in your operations. With Entegris’ expertise, you can discover where and how to implement cleanrooms, detect contamination at parts per billion levels, and select chemically and thermally compatible materials. Meanwhile, our optimization capabilities help you design scalable closed processes with minimal material exposure.
Detection
Manage contamination by detecting particulates throughout your process. Our solutions can help develop extraction protocols that address and represent specific single-use technology and stainless steel equipment plus your product and process needs.
For additional information, including instrumentation and detection capabilities visit our USP Subvisible Particulate Testing page.
Removal
The ability to remove particulates in-process is another solution to help address contamination control. Our in-process removal solutions include:
- Tailored filtration for your specific process
- Microcarrier and cell separation
- Identifying tested chemical- and process-compatible filters
Visit our Life Sciences Filtration resource page to learn more about our filtration portfolio.
Application Note
Particulate Contamination Levels in Single-Use-Systems
Discover how Aramus™ single-use bag assemblies are manufactured to the highest degree of cleanliness in order to provide the best possible outcomes for patients, researchers, and manufacturers.
Animation
In this short animation, you’ll understand how sterile filtration is used in sensitive biotech applications to help deliver pure products with reliable yield.