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Occasional Contributor
Posts: 5
Registered: ‎11-13-2015
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Accepted Solution

Oven validation kit

Hi,

 

I've previously used an oven validation kit from QI Medical.  The product was discontinued.  Any recommendations for what product to use now?

Expert
Posts: 1,142
Registered: ‎02-23-2010
0

Re: Oven validation kit

Thank goodness they pulled their product from the market.  Like this test and the Pyrotest.  Many of their products do not work and I do not recommend using their growth-based media products because of problems supporting growth.  There a couple of companies that sell ECV (Endotoxin Challenge vials).  If you GTS (Google that **bleep**), you will find options to consider. The company called Lonza prepares ECVs for the pharmaceutical industry.  http://bio.lonza.com/uploads/tx_mwaxmarketingmaterial/Lonza_ManualsProductInstructions_Endotoxin_Cha...  Hope this helps. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Occasional Contributor
Posts: 5
Registered: ‎11-13-2015
0

Re: Oven validation kit

Thank you, Eric!  Lonza supplies the LAL to QI, but Lonza's process is much more intensive than the QI Medical product.  How often is the depyrogenation validation  recommended?  I asked both Lonza and Charles River and it appears to be up to the facilities' discretion.  Any thoughts?

Expert
Posts: 1,142
Registered: ‎02-23-2010
0

Re: Oven validation kit

Typically, depyrogenation cycles only have to be verified once a year based on "worst-case" load sizes.  

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.