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Pre-Sterilized Single Use Assemblies

January 4, 2010

 

Single-Use Components Pre and Post Gamma Irradiation

The easy part of the single-use component set ups is to specify the product and define the system.  The next step is to then get the single use set up validated and commissioned.  One thing that always seems to be overlooked is the cleaning of the single use components/setups.  As part of our service to the single use industry, we have partnered with a company that will gamma irradiate any of these parts or setups.  While PTFE, FEP and other fluoropolymer based materials are not recommended for gamma irradiation, most other components can.  These would include silicone tubing, C-Flex tubing, manifolds, pump tubing manifolds, single use connectors and other parts and manifolds. 

Holland performs these services for several major pharmaceutical and bio-tech companies and to some companies that provide product to these industries.

 Attached are some pictures that show a tubing setup that was purchased as non gamma irradiated and subsequently gamma irradiated.  As a part of the service, a sticker that is placed on the bag that changes colors when exposed to the irradiation.  As an added service, Holland also adds a label to the bag that states the product has been irradiated.  There is also a documentation package that goes with the parts that shows the irradiation time and level of concentration.

 So when you have components that need to be gamma irradiated, let us know, we have the knowhow to make you sterilization issues go away.

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