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.

Defining VHP Sterilization and Biodecontamination – Common Denominators and Differences
VHP Applications History VHP has decades of successful use as a bio-decontamination process in the pharmaceutical industry and as a sterilization process in the medical device industry. This article will discuss the similarities and differences between VHP decontamination and sterilization processes, the regulatory standards that govern each method... read more
CAR-T-Similars: Will We See Future Biosimilar Versions of CAR-T Therapies?
Since the first monoclonal antibody (mAb) drug was approved in 1986, more than 100 different mAbs have been approved by the U.S. FDA (Food and Drug Administration) and EMA (European Medicines Agency). During this period, manufacturing scaled up from an almost lab-like process to pharma-grade manufacturing with greater standardization and quality, ... read more
Disinfect, Autoclave or Use Multiple-Bagged Disposables? Moving Materials into Controlled Areas Safely and Efficiently
Transferring equipment into and out of cleanrooms and critical zones has proven to be one of the greatest sources of contamination in the manufacture of sterile pharmaceuticals. To minimize the potential for adverse effects on patients, cGMP and EU GMP regulations have been tightened. Transfer procedures are complex, with materials typically having... 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