Safeguard Your Sterile Tubing Connections

Reduce variability of contamination in your process by standardizing sterile tubing connections with a functionally closed system.

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The Cost of a Sterility Failure at Any Point in the Manufacturing Process

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.

How It Works

See how SCD IIB welders can help you optimize your manufacturing process.

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

SCD IIB Welder Connects:

Polyvinyl chloride (PVC) tubing:^*
Outer diameter: 5.46 mm (0.215 in)
Wall thickness: 0.84 mm (0.033 in)

C-Flex^® tubing:
Outer diameter: 6.35 mm (0.25 in)
Inner diameter: 3.18 mm (0.125 in)

^*Use PVC tubing with a nominal outer diameter (OD) of 5.46 mm (0.215 in) and a wall thickness of 0.84 mm (0.033 in) or C-Flex tubing with a nominal OD of 6.35 mm (0.25 in) and a nominal inner diameter of 3.18 mm (0.125 in). Warning: The tubing sizes and types listed have been tested by Terumo Blood and Cell Technologies for weld strength and sterility; however, some users have had successful results using other types of thermoplastic tubing. PVC and C-Flex tubing are acceptable forms of tubing for use with this product. If you choose to use tubing other than that specified, it is your responsibility to test for weld strength and sterility according to the standards appropriate for the desired application. Use of non-specified tubing could cause a low-strength, nonsterile weld.

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Materials

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