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SCD IIB Sterile Tubing Welder in use

SCD IIB Sterile Tubing Welder

Help safeguard your functionally closed system and support process optimization

Take a look at data related to a sterility failure at any point in the manufacturing process

USD $10,000 to USD $1 million¹

Potential cost to fix sterility failure

The Parenteral Drug Association, in collaboration with the International Society for Pharmaceutical Engineering (ISPE), conducted a benchmarking survey that estimated a failed pharmaceutical run investigation could cost between USD $10,000 and USD $1 million. 

 

USD $175 million in fines²

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 after a virus was found to have contaminated a bioreactor. 

11% of recalls³

Percentage of sterile-product recalls due to microbial contamination

An analysis of 642 recalls related to microbiological control showed that 80% involved sterile products, and 11% of these sterile products were recalled due to microbial contamination. 

How the SCD™ IIB Sterile Tubing Welder can help

Safeguard your sterile tubing connections and support optimization in your cell and gene therapy manufacturing process with the SCD IIB welders from Terumo Blood and Cell Technologies. 

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 procedures (SOPs) 

Mobile – Easily move the lightweight, compact device where it is needed

SCD IIB connections

This welder accommodates both polyvinyl chloride (PVC) and C-Flex tubing.

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)

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Disclaimers and notes

  1. Macher J. Business case for quality. Presented at: Pharmaceutical Quality System (ICH Q10) Conference, Arlington, VA, October 4-6, 2011.
  2. Perrone M. FDA fines Genzyme $175M for manufacturing problems. San Diego Union-Tribune. https://www.sandiegouniontribune.com/sdut-fda-fines-genzyme-175m-for-manufacturing-problems-2010may24-story.html. Published May 24, 2010. Accessed February 14, 2024.
  3. Sutton S, Jimenez L. Am Pharm Rev. 2012;15(1):42-57.

*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. 

Note: C-Flex is either a registered trademark or trademark of Saint-Gobain Life Sciences in the United States and/or other countries. 

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