How is Keystone Pharmacy using Fireflies to Increase Your Safety and Convenience?
As June comes to a close, the night sky around our home is lighting up with fireflies. It is beautiful to watch this magical light show being performed by these little creatures. But did you know that Keystone Pharmacy is investing a huge amount in “firefly technology” to speed the turnaround time on your sterile compounded medications while at the same time further improving the safety profile of your compounded sterile medications.
Let me explain…….
Past sterility studies have relied on “turbidimetric analysis” to determine if a sample is sterile or not sterile. The product would be filtered and then the filter incubated in a growth media. At the end of the incubation period, the media would be examined. If the media was clear, the sample was deemed to be sterile, if it was cloudy, something grew in the media and the sample was deemed not sterile. In order to ensure that there was sufficient growth to see with the human eye, the samples had to incubate for 14 days as specified in the United States Pharmacopeia regulations. I have always been somewhat suspect of this method because the human eye can often be tricked and have not entirely trusted this method. So what does this have to do with fireflies? Fireflies have a unique chemical called Luciferin-Luciferase. When Liciferin-Luciferase binds to adenosine triphosate (ATP), it emits light. This is how fireflies “light up”, but all living organisms have ATP. If something is alive in the sample and Luciferin-Lucierase is added, the sample will emit light. This allows a highly sensitive analytical machine by Pall Scientific, Inc called a Pallcheck®, to detect microorganisms with very high accuracy and sensitivity down to very low levels.
Now, after only three days of growth in the media, if there are any organisms present, the system will detect them. I have validated this system to detect down to a single organism in three days. Not only is the Pallcheck® system faster than the traditional turbidimetric method, it is also much more sensitive and leaves no room for interpretation. It is absolutely objective. What does this mean to you? Keystone Pharmacy is very strict about not releasing sterile products until they have passed sterility testing. I am sure that you would not want it any other way. After all, you don’t want to inject a non-sterile product into your body and risk infection, do you?
In the past, you may have heard that your compounded sterile product may take 14 days because it needs to pass sterility testing. Our new investment and the lowly firefly let us achieve sterility data and turn around your compounded sterile product in as little as three days.
I am continually looking for ways to improve safety. My investment in the Pallcheck® system has topped $70,000 so far. This is in addition to the $94,000 that Keystone Pharmacy spent testing your sterile and traditional dosage forms last year. I am committed to turning out the highest quality compounded products and with the help from my little friend, the firefly; I have made another huge leap forward.  Validation reports can be viewed at Keystone Pharmacy upon request.