Category Archives: Dan’s Perspective

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 …

10-9-2012 Gibraltar was just awarded the prestigious Seal of Excellence Award for  outstanding customer service for the third straight year by the industries’ leading independent trade organization, the American Counsel of Independent Laboratories (ACIL). Since first entering the competition in …

An expert two day Hands on Seminar for Professionals involved with Sterilization and Disinfection with an emphasis on steam sterilization related to Aseptic manufacturing practices as distinguished from reprocessing of single use medical devices.   GIRT Seminar

The D-10 quantal value describes the ability of a chemical or physical agent to reduce an exposed Microbial population 90% (one log10) under standard conditions of Time, Temperature, Concentration or Dose.  It is widely used in infection and contamination control in pharmaceuticals, medical devices, tissue …

Reprocessing is a relatively new critical discipline that requires a multidisciplinary approach. After a surgical procedure the instrument needs to be processed such that it is suitable for safe reuse in a patient. The basic requirement is that the instrument …