Scientific Library

Traditional, manual methods of environmental monitoring can be subject to numeration errors as well as data traceability and integrity issues, which result in overall inefficiency. Want to uncover how automated methods outperform these traditional approaches? Download our infographic now and gain exclusive insights.

An endotoxin test involves several critical steps to ensure accurate and reliable results. Here are the 10 key elements of an endotoxin test.

Embark on a 6-part journey designed to challenge the traditional norms in endotoxin detection.

Accuracy of Environmental Monitoring (EM) is key in maintaining control and preventing contamination issues in pharma companies, and culture media plays a pivotal role in Environmental Monitoring programs. Culture media must provide accurate, reliable, and consistent results. Their ability to promote microorganisms’ growth must be demonstrated and validated throughout the shelf-life of the culture media, using different batches, and intra- and inter-batch reproducibility tests inoculating strains described in the Pharmacopoeias and pharmaceutical plant environmental isolates are recommended to be carried out.

For drug developers, manufacturers and diagnostic testing companies such as bioMérieux, the safety of their end consumer – patients – is their greatest priority. Even minor lapses in production processes or product testing of pharmaceuticals can create significant risks for the safety of patients, as well as undermining public confidence in the wider healthcare industry. Companies working in this field must pay attention across the whole product chain to reduce risks and center patient safety. Such measures include ensuring the quality and consistency of raw materials, handling and storing raw materials appropriately, initiating well-designed manufacturing processes that minimize contamination and conducting effective environmental monitoring (EM).

For the past 50 years, the Limulus amebocyte lysate (LAL) test has served as the foundation of drug and medical device manufacturing endotoxin control. Now, however, the United States Pharmacopeia (USP) has recognized the need to transition to recombinant methods.

Over the years, presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the U.S. Burkholderia cepacia is one of the most prominent objectionable microorganism associated with 102 non-sterile drug recalls from 2012 to 2019(1,2). It is an opportunistic pathogen and has a distinctive ability to overcome antimicrobial preservative systems.

Four bioproduction manufacturers evaluted the BIOFIRE® FILMARRAY® 2.0 system — interested in the results in an easy-to-digest format? Download a one page Scientific Study Summary that details the study's objectives, outline, and conclusion!

Two cell therapy and four bioproduction manufacturers evaluted the BIOFIRE® FILMARRAY® 2.0 — interested in the results in an easy-to-digest format? Download a one page Scientific Study Summary that details the study's objectives, outline, and conclusion!

BACT/ALERT® allows virtually anyone to test for product contamination anywhere, at any time. This proven solution is compatible with even the most complex matrices and can be used for both in-process and release testing.

Matrix-assisted laser desorption ionisation (MALDI) uses a laser to absorb energy from a matrix to create ions with minimal fragmentation from large molecules.

Aspergillus brasiliensis is a fungus and is one of the most common species of the genus Aspergillus. It is ubiquitous in soil, a common food contaminant, and is also regularly reported from indoor environments such as industrial plants.

Bacillus subtilis is a gram-positive bacteria found in soil and the gastrointestinal tract of ruminants and humans. It is rod-shaped and can form a tough, protective endospore, allowing it to tolerate extreme environmental conditions1.

Candida albicans is an opportunistic pathogenic yeast1 and a common member of human gut flora. It is usually a commensal organism, but it can become pathogenic in immunocompromised individuals under certain conditions.

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.

Cutibacterium acnes (C. acnes) is a Gram positive bacteria that prefers anaerobic (without air) growth conditions1. Cutibacterium acnes can be found on the skin of virtually every human, and it is one of the bacteria that can cause acne.

Staphylococcus aureus, is a species of Gram-positive spherical bacteria that commonly causes surgical and skin infections, bacteremia (bacteria in the blood) and food poisoning. It’s a ubiquitous microorganism, and can be found on the skin of warm blooded animals.

Mycoplasma is a genus of gram negative bacilli belonging to the Mollicutes class. Mollicutes include Mycoplasma and Acholeplasma. Mollicutes lack a cell wall and are of very small size (200-300 nm) and have a small genome. Since Mollicutes cannot produce many of the enzymes needed to survive they are parasitic on eukaryotic cells.

Bioprocessing is a type of manufacturing that uses living cells to produce a product. In pharmaceutical bioprocessing, a living cell is manipulated to manufacture the drug of interest in bioreactors and is then purified and formulated to create the end product.

Pseudomonas aeruginosa is a gram negative, rod-shaped bacterium found widely in the environment, such as in soil, water, and plants. They usually do not cause infections in healthy people, but if they do, it is generally mild. It can cause disease in plants and animals, including humans.

Acholeplasma is a genus of gram negative bacilli belonging to the Mollicutes class. Mollicutes include Mycoplasma and Acholeplasma. Mollicutes lack a cell wall and are of very small size (200-300 nm) and have a small genome. Since Mollicutes cannot produce many of the enzymes needed to survive they are parasitic on eukaryotic cells.