Terumo SCD - Model IIB - Sterile Tubing Welder
Reduce variability of contamination in your process by standardizing sterile tubing connections with a functionally closed system.
- Reliable - Create strong, dependable tubing connections
- Sterile - Functionally closed system supports lower chance of contamination and product loss
- Fast - Speed up manufacturing time with sterile welds created in about 30 seconds
- Cost-effective - Affordable equipment and wafers support higher margins and lower manufacturing costs compared to competitive devices
- Standardized - Easily implement SCD IIB welders into the manufacturing process and your standard operating procedure (SOP)
- Mobile - Easily move the lightweight, compact device where it is needed
USD $10,000 to USD $1 Million
The potential cost to fix a sterility failure
The Parenteral Drug Association in collaboration with ISPE conducted a benchmarking survey that estimated that a failed pharmaceutical run investigation could cost between USD $10,000 and USD $1 million.
Macher J. Business case for quality. Presented at the Pharmaceutical Quality System (ICH Q10) Conference, Arlington, VA, October 4-6, 2011. Accessed November 9, 2020. https://www.fda.gov/media/82992/download.
USD $175 Million in Fines
The potential price of inadequate microbial contamination control
A drug manufacturer was fined USD $175 million by the U.S. Food and Drug Administration and was forced to temporarily close its Massachusetts plant in 2009 after a virus was found to have contaminated a bioreactor.
Petrochko C. Gene drugmaker hit with heavy fines. MedPageToday. May 25, 2010. Accessed July 7, 2020. https://www.medpagetoday.com/publichealth policy/fdageneral/20290.
11% of Recalls
The percentage of recalls of sterile products due to microbial contamination
An analysis of 642 recalls related to microbiological control from 2004 to 2011 showed that 80% involved sterile products, and 11% of these sterile products were recalled due to microbial contamination.
Sutton S, Jimenez L. A review of reported recalls involving microbiological control 2004-2011 with emphasis on FDA considerations of “objectionable organisms.” Am Pharm Rev. 2012;15(1):42-57.