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.

Is the Timing of the Microbial Release Testing of Drug Products Important?
The authors have become aware that regulators, especially during site inspections, are beginning to ask questions about whether pharmaceutical manufacturers have considered setting time limits from the date of manufacturing to the microbial release testing of their finished drug products. Although good manufacturing practice regulations, guidance ... read more
As Prototypes Are Refined into Standardized Solutions, It Is Time to Consider Robotics and Automation in Microbial QC
At a time when the pharmaceutical industry is entering a new transformational phase, the promise that automation, robotics, and concomitant digitalization hold is getting more and more recognition. The transition has long reached manufacturing, and now it seems to be the turn of microbiological quality control. In the interview also published in ... read more
Executive Q&A: Automated Microbiological QC Workflows Will Likely Become Commonplace
Anne Weeks and Anke Hossfeld share insights on why and how automation and robotics will change microbiological QC in pharmaceutical manufacturing. 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