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.

Validating Alternative Microbiological Methods: A Guide to USP <1223> and Validation of Rapid Methods
Microbiological testing plays a crucial role in ensuring the safety and quality of pharmaceutical products. Traditional methods, such as culture-based techniques, have been widely used for decades. However, with the advancement of technology, alternative microbiological methods have emerged, offering potential advantages in terms of speed, ... read more
Optimizing ADC Bioassays: LC-MS/MS Blends Speed with Cost-Effectiveness
An innovative new treatment is gaining momentum in cancer therapies and giving hope to patients worldwide. Antibody-drug conjugates (ADCs) are sophisticated therapeutics that combine the targeted precision of antibodies with the potent cell-killing power of cytotoxins connected by a linker, as seen in Figure 1. ADCs deliver treatment directly to ... read more
Material World: Selecting Representative Surfaces for Disinfectant Compatibility and Efficacy Studies
Disinfection of pharmaceutical facilities represents a critical element of contamination control. With disinfectant efficacy testing, the surface or coupon (carrier) test is by far the most representative method of evaluation (in contrast to testing solutions in suspension). Within a pharmaceutical facility there will be a range of different ... read more

Microbiological Quality of Non-sterile Products: Culture Media for Compendial Methods
High quality harmonized USP <61> & <62> compliant media is key to successful non-sterile release and incoming testing of materials that need to be free of specified and objectionable microorganisms. Download the updated brochure today, now including BCC media options and everything else you need for MLT. read more
eBook: Microbial Identification - Trends and Technologies for Aseptic Manufacturing Facilities
eBook content includes a wide variety of topics for microbial identification in pharmaceutical facilities. Strategies, tools, and technologies are featured. Articles feature an analysis of FDA microbial enforcement reports, lab microbial identification systems, a look at cleanroom microbial monitoring methods, water system ... read more
eBook: The Modern Microbiologist’s No-Nonsense Guide to Quality Control
The growth promotion test (GPT) can be a hassle, but it’s necessary for determining if a new batch of media is acceptable. Pharmaceutical Microbiologists have the great responsibility of ensuring their products are free of harmful contaminants and safe for consumers. Follow our best practices below to make your testing process ... read more
eBook: BET Automation Simplified: How to achieve simple, automated endotoxin testing
To succeed and thrive in today’s pharmaceutical QC environment, it is critical to increase efficiency while maintaining compliance. The need to quickly and accurately test samples, review data, and release products drives innovation of analytical instrumentation and software. While automation and robotics exist to improve ... read more
eBook: Reliable, Confident, Environmental Monitoring System
This comprehensive eBook provides information for reliable, confident environmental monitoring and classifying of pharmaceutical cleanrooms to improve product quality, enhance data integrity and shareability, and easily meet regulatory requirements. 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