Unlike our counterparts in the chemical world, consistently precise and accurate results from pharmaceutical microorganism quality control are encountered less often. In other words, quantitative microbiological testing allows for fairly large discrepancies in the results due to the inherent difficulties in dealing with living organisms as well as quantifying them.
The intellectual properties and proprietary methodologies used in making BIOBALL® redefine what was considered as quantitative microbiology and make it simple to get precise and accurate quantitative microbiological quality controls batch after batch.
Today, there are mandatory compendial strains, derived from various culture collection libraries such as ATCC, NCTC/NCPF, NBRC, DSMZ, etc, and are used to qualify in-house or pre-poured culture media for various purposes in a manufacturing facility. Over last couple of decades , there has been a rising emphasis on extending these panel of test microorganisms with inclusion of a facility’s own in-house isolates in routine microbiological QC testing such as culture media qualification and method validation.
Over last decade, the top in-house (environmental) isolates developed into BIOBALL® have remained extraordinarily consistent. Following is the list of top 10 in-house isolates found to be the most common ones isolated in a pharmaceutical manufacturing facility during environmental monitoring programs, tracking and trending, and therefore frequently requested by customers to be converted into BIOBALL® format as part of bioMérieux’s BIOBALL® In-house Isolate Service.