Author Archives: Daniel

Non-sterile (P) Rate Non-sterile (P) Rate Units Tested (N) Percent chance to fail sterility test (F) 1:10,000 0.0001 1 0.01 1:1000 0.001 1 0.1 1:100 0.01 1 1.0 1:10 0.1 1 11.1 1:10,000 0.0001 5 0.05 1:1000 0.001 5 0.5 …

I know that we are often very critical of how we look and how we sound to others. In general we want to “look good” in the eyes of others. Perhaps our reality of ourselves is vastly different than the …

I have just returned from an all-day consultation audit of a compounding pharmacy. Our role is to perform a critical audit to help the firm identify the source of a fungal contaminate that was found in its sterile preparations. It …

Recently we learned of a case where a single use device was tested in an academic institution in Europe. It was concluded that the two different, sterile, non-cytotoxic, virgin, single use devices contained protein burden [proburden]  levels of 4.72 and …