Micro Contamination - Emoderivates (producing albumin, etc from human plasma)

[veronica_leon75]

Micro Contamination

Hi everybody, First of all, let me wish you a HAPPY NEW YEAR!

I have been just hired by an hemoderivates (producing albumin, etc from human plasma)manufacturing plant, to establish a Quality Assurance system. The Plant Manager told me that 8 months ago, the plant was shut down for 5 months by the Government due to a pyrogen contamination. Today they still have problems with the water system. To start, I am planning to conduct a pre/assessment to understand their problems. Then I need to develop a plan to implemente the QA system. My concern is because I am not a microbiologist. Whta should you recommend ? Where can I find info about items like design contruction and installation for this type of industry.

Thanks, in advance : confused:

 

[DaveG]

This is probably too late a response as I've just joined the forum.

That being said however, for others looking for references on micro, particularly pyrogens, the best place to check is the AAMI (American Association of Micriobiological Industy).

AAMI is the leader in promulgating standards for micro and has a number of sources and publications that should assist you greatly.

Good luck.