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Why Pharmaceutical Developers Use BIOBALL® 

For Microorganism Quality Control

July 07, 2022

bioball vial and micrococcus luteus

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. 




Interestingly, these strains have remained consistent over the years due to various reasons such as some of these are found on human skin and humans present the highest risk in a cleanroom environment. Others are spore-formers, water isolates or mold.

During pharmaceutical manufacturing, each facility must perform environmental monitoring that measures and monitors levels of microbial bioburden. Keep in mind, the pharmacopeias are not harmonized for environmental monitoring and each has varying requirements that demand very low initial contamination recovery rates or the detection of very low cfu levels. The requirements vary depending on the criticality of the manufacturing area to product sterility. Depending on the cleanroom classification, there can be very stringent requirements on the outcome of environmental monitoring.


Use of Standardized Strain Method

bioMérieux maintains specific methods to ensure a high level of standard. BIOBALL® is easy to use and requires no preparation or pre-incubation, and is an accredited reference material under ISO 17034 standards.

Unlike other products on the market, BIOBALL® can be used straight from the freezer, which means no acclimatization period or heating of rehydration fluid. Due to its water-soluble nature, BIOBALL® dissolves immediately when rehydrated, reducing hands-on time and improving lab efficiency. The step-by-step method follows:

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

Use of Proprietary Cytometry Technology

BIOBALL® uses proprietary cytometry technology that allows unprecedented accuracy in quantitative microbiological quality control and delivers greater precision with a reliable number of micro-organisms per ball. This batch-to-batch consistency significantly reduces the risk of failed quality control due to variability of inoculum.


To ensure your method validation and growth promotion tests produce the correct results every time, BIOBALL® SINGLESHOT and MULTISHOT products precisely and accurately deliver a specific Colony Forming Unit number—batch after batch. To discover how BIOBALL® in-house service can help to convert your non-compendial EM strains into BIOBALL® format and simplify routine microbiological QC testing, contact a bioMérieux expert now.


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