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October 1998


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Linda Regan <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Tue, 6 Oct 1998 09:19:41 -0700
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I have two questions for any virus experts out there.

1.  Has anyone been required to look at viruses as a part of their
sterility testing? We have a product that is made from bovine-sourced
collagen and we have been asked to address the issue of viral safety for
our PMA submission.  The product is terminally sterilized by gamma
irradiation.  Has anyone else out there validated a process for viral
inactivation that would like to share their experience with me?

2.  Also, we do not have cell culture facilities at our company and I
would appreciate if anyone knows of a contract lab that will screen
products for virus or if there is another method to detect/quantitate
viruses that can done without special equipment.  I have heard of whole
blood agglutination assays to quantitate viral titers.  Anyone know more
about this?

Linda Regan