Microbiology

Pharmaceutical microbiology plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products. Modern instruments deliver sensitive, reliable solutions to support microbiologists across the full spectrum of workflows. These innovations help pharmaceutical manufacturers ensure compliance while maintaining efficiency and patient safety. In this hub, explore articles, webinars, and other informative resources related to pharmaceutical microbiology.

Making the Most of Your Microbial Data: Organism Risk Assessment and The Importance of Microbial Identification
When we experience microbial recovery in our components, intermediates, or finished products, the first response may be one of panic. Think of it – a microscopic creature, almost alien, appearing out of nowhere with the potential to kill. What is this thing that I cannot see without the aid of powerful optics? Where did it come from? What does it ... read more
Developing Suitable Alternative Procedures to Sample Novel Dosage Forms for Microbial Limits and Specified Microorganisms Testing
To a pharmaceutical microbiologist, there are two categories of finished pharmaceutical products: non-sterile and sterile. At the end of manufacturing, no microorganisms are present in sterile products. Examples of sterile finished dosage forms are injections, intravenous fluids, and ophthalmic drops (Figure 1A). In contrast, at the end of ... read more
The Evolution of Eco-Conscious Endotoxin Testing
Over the past century, few species have experienced such a profound shift in public perception as the American horseshoe crab (HSC). Prior to 1920, millions of Limulus polyphemus were harvested for livestock feed and fertilizer. By the late 1940s, bounties were paid for their destruction due to their perceived threat to commercially important ... read more

eBook: TOC and Microbial Detection Monitoring
Proper and thorough monitoring of pharmaceutical water systems is imperative to deliver the highest quality products to patients. read more
Impact of Data Integrity Audits on Pharma Microbial QC Labs
Most people are aware of the requirements of the code of federal regulations 21 CFR Part 11 for computer software security, which have been a major pharmaceutical IT focus for approximately 10 years. read more
Evaluating Integrated Analytics for Single-use Mini Bioreactors
In the past decade, single-use automated micro bioreactors have been widely adopted in biopharma facilities for scaling-down mammalian and microbial cell processes for production of biologics. read more
Detection of Pyrogens Pyromat 2019008029
A pyrogen is, by definition, a substance that produces a rise in temperature in a human or animal. read more
Rapid Sterility Testing of Filterable Samples
Sterility testing of final drug products is a mandatory release test for pharmaceutical companies and is critical to ensure patient safety. However, traditional methods such as membrane filtration require a minimum incubation time of 14 days. This long time to result delays product release and increases storage costs. This ... read more

Clean Facility of the Future: Advanced Microbiology Technologies for Cleaner Facilities and Purer Products
As the industry becomes more focused on bringing biopharmaceuticals to market the pressure to increase production, decrease costs and ensure the highest quality and safety for finished products becomes greater and greater. And ... read more

On-Demand Webinar: Rapid Sterility Testing as the Critical and Final Result for Product Release
In this webinar, hear from Eric Chenelle, Product Manager from Rapid Micro, as he discusses Rapid Sterility Testing as the Critical and Final Result for Product Release. read more
Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products
Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and error in the Clean Facility of the Future Documentary. read more