You may want to look into the Ameridose claims a little closer . If they are testing every batch, how do they get it to you so quickly? I believe they misrepresent their testing. It seems what they mention as a batch vs lot may be different than USP 797? What it looks like they test is their source container from which they make the individual units shipped to your hospital. This is not what 797 suggest. If you order 50 bags or syringes, do they pull bags from the batch they made from the lot they tested and then perform a sterility test? My understanding is that they start from Non-Sterile powders on a number of items, therefore needing a sterility test for their lots. CAPS does not start with any non-sterile powders unless they are not commercially available. I believe this is just one item in their entire portfolio. Sterility breaches come in many forms, but mostly during the individual unit compounding from poor technique. With regards to stability, I would ask the Ameridose rep and any outsourcing rep for that matter to bring in stability on the items you purchase. This should not be a summary on company letterhead, but an analysis performed by a credible lab. Has anyone had an instance where stabiity was reduced after having somethingmuch higher or have the handling change? Room-Temp that is now refrigerated?
Best Wishes and looking forward to the upcoming Vegas meeting
