Couplings simplify steam-in-place process
Colder Products has developed a novel Steam-Thru connection (STC) to streamline critical steam-in-place processes used in numerous biopharmaceutical applications.
Colder Products has developed a novel Steam-Thru connection (STC) to streamline critical steam-in-place processes used in numerous biopharmaceutical applications.
The STC serves the dual function of valve and connection, eliminating the costly and labour-intensive steps of traditional steam sterilisation processes.
This also speeds the connection process, and reduces the contamination risks associated with multiconnection steam-in-place applications.
Colder's STC enables biopharmaceutical companies to sterilise the flow path and initiate connections between a bioreactor and media bag without adding plumbing connections or additional steps to the process.
The uniquely designed STC uses a steam trap to rid the connection of steam during the sterilisation process.
This contrasts with traditional steam-in-place processes, which create "dead legs" where steam containing remnant micro-organisms become trapped in the connection chamber, increasing the chances of contamination.
"The disposable STC re-invents the steam-in-place process by eliminating connection steps, reducing validation concerns, and removing opportunities for contamination", said Carolyn Franceschi, Medical Business Unit Manager of Colder Products.
"The speed at which connections can now be made will streamline the new drug development process, yielding substantial savings for biopharmaceutical companies".
As a disposable device, the STC eliminates cleaning and process validation issues associated with re-useable connections.
These labour-intensive cleaning and validation processes introduce opportunities for both contamination and noncompliance with FDA regulations.
Traditional connection processes also require the use of capital equipment, such as a laminar flow hood, which increase the cost, time and space needed to make connections.
The STC works with existing systems without retrofit, enabling a seamless transition to this highly efficient steam-in-place process.
The device features industry standard terminations of 0.75in Mini and 1.5in Tri-clamp, and its 0.375 and 0.5in hose barbs connect to popular tubing sizes.
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