Again, these quotes are from the April 29, 2008, House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml
Brown was questioned in those hearings by U.S. Representative, Jan Schakowsky:
Answer by Brown: Another piece of equipment that was the centrifuges that they used to get rid of the waste protein. They used two of them. They had one that would be in use and they would clean the sludge out of the other one, while, to find out how long they should run the one that was going, that would last 30 minutes, without getting to full. And that was a very unusual manufacturing step. It wasn’t described in the procedures for how to use the centrifuges. So you had to actually be at the plant to try and figure out what they were doing.What is so disturbing about this revelation is that this was not a matter of simple neglect, made worse by a long standing practice of poor oversight. This was a flawed process from its inception. This process does not even contemplate a scientific process to assure that the API is pure.
Normally you see one centrifuge and you run your material thru it and separate the solid from the liquid.
A third piece of equipment that was outstanding to me was their lyophilizer, it was, they didn’t have the software that would provide for the person running it, for the perimeters, that he put in it.
Q by Rep. Schakowsky: What is that?
A: The lyophilizer is a big freeze dryer.
Put in trays of liquids and they turn into solids after days, sometime. You freeze the liquid and you warm it up slowly, they are under vacuum. So it turns into a solid material. So and for this lyophilize there were no records of the actual perimeters that were punched into the screen at the front of it. But there was no screen at the front of it. No way to tell what temperature they actually used to dry the material.
Q: So this is clearly substandard or not up to par, or what should be?
A: Yeah, the settings weren’t there.
Q: Why couldn’t Baxter’s audit have found these things, do you think?
A: I don’t know. I walk thru facilities as part of my inspection. I don’t know if they do that.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
