The use of single-use component assemblies and systems
have been implemented in pharmaceutical and biopharmaceutical production over the past 20 years to increase process flexibility and provide economic benefits, including elimination of cleaning validation work. The supply chain may be complex, with numerous suppliers and multiple production stages and sites for a drug product. Concerns can be raised if use of single-use elements is compromised by a failure to consider transit challenges within the supply chain or production process, leading to higher damage and shipping costs.
Last year, the Bio-Process Systems Alliance (BPSA) formed a committee to provide guidance on how single-use suppliers and end users can utilize laboratory and real-world testing to qualify their packaging systems and enhance supply chain performance. The group is comprised of industry experts from single-use component suppliers, a drug manufacturer, academia, and a testing laboratory, including Smithers. Rich Salzstein
, PhD, Business Development Manager, and James Raw
, Operations Director for Packaging Testing, are leading the committee, which also includes representatives from Colder Products Company, Entegris, GE Healthcare, Michigan State University, NewAge Industries, Pall Corporation, Sanofi Pasteur, and Sartorius Stedim Biotech.
“It’s crucial to develop a testing program that meets regulatory submission requirements and anticipates potential hazards a package might face that could compromise the drug product or its processing,” said Salzstein. “Our goal as a committee is to help this industry understand the benefits of transit and distribution testing and develop guidance to help them get started.”
The committee aims to illustrate the spectrum of benefits in testing in a whitepaper currently under development.
“Of course, transit testing
can help satisfy regulatory requirements and mitigate damage, but there are other benefits that are less well known,” said Raw. “This type of testing can help improve supply chain efficiency, reduce costs, and identify opportunities for lightweighting
and sustainable practices
“This committee is a really exciting opportunity for our experts in adjacent industries to combine their knowledge for the benefit of a larger group,” said Nat Leonard, Group President, Life Sciences
, Smithers. “I am extremely confident that James, Rich, and their fellow committee members will produce valuable guidance for the single-use industry and drug production in general.”
To get in touch, please contact Rich Salzstein or James Raw.