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Sterility testing of transdermal patches [View Printable]
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Loni
Group: Member
Posts: 6
Joined: Mar 15, 2005
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we need to provide a method for sterility testing of sterile transdermal patches with special protein collagen layer.
We cannot find any test method in the US EP and BP. I am afraid that apart from that classical test or sterility are not applicable beacause the collagen layer causes turbidity in thioglicolate medium.
we think that if find a way to remove thye collgane layer the problem with the turbidty could disappear. But we do not know how to do this!
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| Posted Jun 05, 2007, 20:04 PM |
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Jorge1907
Group: Member
Posts: 15
Joined: May 24, 2008
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If sterility is your objective - I dont see how you can eliminate the collagen layer you mention.
why not culture the entire patch and streak thio on TSa for growth.
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| Posted Jun 02, 2008, 19:33 PM |
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