Why Pharmaceutical Developers Use BIOBALL® for Microorganism Quality Control
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.
Top 10 Most Common Microorganisms isolated in Pharma Labs
The genus Micrococcus is not considered to be pathogenic. However, Micrococcus strains have been reported to cause various types of infections, usually as opportunistic pathogens. Thus, Micrococcus luteus strains were associated with septic arthritis, prosthetic valve endocarditis, and recurrent bacteremia.
Staphylococcus epidermidis is a common symbiont bacterium that can become infectious once inside the human host. They are among the most common causes of nosocomial infection in the United States and can lead to serious complications.
Staphylococcus hominis is a species of Coagulase-negative staphylococci (CoNS). Among CoNS, S. hominis is one of the three most frequently identified isolates recoverable from the blood of hospitalized patients. These bacteria are recognised as potentially opportunistic pathogens and may cause bloodstream infections, endocarditis, peritonitis, osteomyelitis, bone and joint infections.
Ralstonia pickettii is a low-virulence gram-negative bacillus that may be associated with infections related to health care and may cause bacteremia. Ralstonia pickettii bacteremia is uncommon but is related to the contamination of medical products, mainly in immunodepressed patients.
Bacillus cereus is a facultatively anaerobic, toxin-producing gram-positive bacterium found in soil, vegetation, and food. It commonly causes intestinal illnesses with nausea, vomiting, and diarrhea. However, it has been associated with serious infections in immunocompromised hosts and can cause septicemia as well as endophthalmitis, which can lead to vision loss.
Stenotrophomonas maltophilia is one of the less known drug-resistant bacteria that can cause challenging infections. Stenotrophomonas maltophilia is a gram-negative bacillus, initially called Bacterium bookeri, when it was first identified in 1943 from a specimen of human pleural fluid.
Penicillium chrysogenum is also known as Penicillium notatum, the first Penicillium fungi used for the isolation of penicillin antibiotics, which is used for the treatment of Gram-positive bacteria. It is an allergen and has pathogenic activity however it is uncommon in causing disease in humans.
Bacillus pumilus is a ubiquitous Gram-positive, aerobic, rod-shaped endospore-forming bacteria that can be isolated from a wide variety of soils, plants and environmental surfaces, and even from the interior of Sonoran desert basalt (Benardini et al., 2003). The Bacillus subtilis microorganism is ubiquitous in many environments. It is considered as an opportunistic pathogen, meaning the organism only causes disease when a person's immune system is already impaired.
Bacillus thuringiensis (Bt) is a group of strains or isolates of naturally occurring soil bacteria which mainly exerts toxicity through the production of Crystal (Cry) toxins. Cry toxins are used worldwide as aerial sprays or in transgenic plants to control disease-vector insect and crop pest populations.
Bacillus licheniformis has been used for industrial production of proteases, amylases, antibiotics, and specialty chemicals with no known reports of adverse effects to human health or the environment.
How BIOBALL® Quality Control Tests Detect Microorganisms in Pharma Labs
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:
3. Spread, dry and incubate
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.
BIOBALL® for Pharmaceutical Microorganism Quality Control
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.