Compared to the chemical industry, achieving consistently precise and accurate results in pharmaceutical microorganism quality control is encountered less often. Quantitative microbiological testing allows for considerable variability in results due to the inherent difficulties in quantifying living organisms.

The intellectual properties and proprietary methods behind BIOBALL^® redefine what was considered as quantitative microbiology, making it straightforward to achieve precise and accurate quantitative microbiological quality control results, batch after batch.

Today, mandatory compendial strains from various culture collection libraries such as ATCC, NCTC/NCPF, NBRC, DSMZ, etc., are used to qualify in-house or pre-poured culture media for various purposes in manufacturing facilities. In recent decades, there has been a growing focus on extending these panels of test microorganisms by incorporating a facility’s own in-house isolates in routine microbiological quality control testing, including culture media qualification and method validation.

Over the past decade, the leading in-house (environmental) isolates developed into BIOBALL^® have remained remarkably consistent. Below is a list of the top 10 in-house isolates most frequently identified in pharmaceutical manufacturing facilities during environmental monitoring programs, tracking, and trending. These isolates are commonly requested by customers to be converted into BIOBALL^® format as part of bioMérieux’s BIOBALL^® In-house Isolate Service.

• Micrococcus luteus
• Staphylococcus epidermidis
• Staphylococcus hominis
• Ralstonia pickettii
• Bacillus cereus
• Stenotrophomonas maltophilia
• Penicillium chrysogenum
• Bacillus pumilus
• Bacillus thuringiensis
• Bacillus licheniformis

How BIOBALL^® quality control tests identify microorganisms in pharmaceutical labs
These strains have stayed consistent over the years for several reasons. Some are commonly found on human skin, which pose the highest risk in cleanroom environments, while others are spore-formers, water isolates, or molds.

Every facility must perform environmental monitoring to measure and track levels of microbial bioburden during pharmaceutical manufacturing. It’s important to note that pharmacopeias have varying requirements that demand low initial contamination recovery rates or the detection of low colony forming unit levels. These requirements depend on the criticality of the manufacturing area for maintaining product sterility. The standards can be particularly stringent depending on the cleanroom classification.

Application of the standardized strain method
bioMérieux upholds specific methods to ensure high standards. BIOBALL^® is recognized as an accredited reference material under ISO 17034 standards and is user-friendly, requiring no preparation or pre-incubation.

Unlike other available products, BIOBALL^® can be used directly out of the freezer, eliminating the need for acclimatization or the heating of rehydration fluid. Its water-soluble properties allow BIOBALL^® to dissolve instantly upon rehydration, which reduces hands-on time and enhances lab efficiency. The process is outlined in the step-by-step method below:

1. Plate
2. Rehydrate
3. Spread, dry, and incubate
4. Enumerate

Application of proprietary cytometry technology
BIOBALL^® utilizes proprietary cytometry technology, offering unprecedented accuracy in quantitative microbiological quality control. Providing a precise number of microorganisms per ball, this batch-to-batch consistency greatly diminishes the risk of quality control failures caused by inoculum variability.

Discover BIOBALL^® for the quality control of pharmaceutical microorgansisms
BIOBALL^® SINGLESHOT and MULTISHOT products deliver a precise and accurate Colony Forming Unit number with each batch, guaranteeing that your method validation and growth promotion tests consistently yield accurate results.

Visit our website to discover how BIOBALL^® in-house services can help to convert your non-compendial EM strains into BIOBALL^® format and simplify routine microbiological QC testing.