Originally Published EMDM May/June 2005
Industry News
Validation Report Demonstrates Connection System’s IntegrityNorbert Sparrow
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| A validation package confirms the Steam-Thru Connection’s resistance to microbes, bacteria, and other contaminants. |
DA manufacturer has released a validation report for its steam-in-place connectors. Testing was performed on the Steam-Thru Connection (STC), developed by Colder Products Co. (St. Paul, MN, USA), for several varieties of contamination.
Bacterial testing, conducted by the University of Minnesota’s Biotechnology Resource Center (St. Paul, MN, USA), verified that a 30-minute steam-in-place process killed bacterial contaminants introduced into the STC. Northview Laboratories (Northbrook, IL, USA) administered a microbial ingress test, which verified the seal integrity of the STC in steam and flow positions after gamma irradiation at doses of 50 kGy.
The seal of the STC in steam and flow positions, also tested by Northview, maintained integrity after two cycles of autoclave sterilization at 128°C. In USP Class VI tests, conducted by NAMSA (Northwood, OH, USA), polysulphone and silicone materials in the STC were tested to meet the requirements of MEM elution, haemolysis in vitro, and physicochemical tests.
Featuring terminations of 0.75 and 1.5 in., the STC is suitable for applications such as cell harvesting and bioreactor feeding. Hose barbs of 0.375 and 0.5 in. connect to popular tubing sizes. The one-step, disposable connection minimizes the risk of contamination, and it works with existing systems without being retrofitted. The validation report can be downloaded at www.colder.com/validation.
For more information, contact Colder Products Co., 1001 Westgate Drive, St. Paul, MN 55114, USA; phone: +1 866 6719165; fax: +1 651 6455404; e-mail: tara.kennedy@colder.com; Internet: www.colder.com.
Copyright ©2005 European Medical Device Manufacturer
