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.

The Misuse of Most-Probable Number in ‘Rogue’ BI Remediation
Use of MPN for resolution of anomalous results assumes a log-linear death curve, which has never been established in a bi-phasic system. read more
The Use of Mycoplasma Reference Standards in the Light of the Revised Ph. Eur. 2.6.7
On 1 April this year, the Ph. Eur. Chapter 2.6.7, in its thoroughly revised form, came into force. It applies to medicinal products derived from or manufactured using living cells or biological systems and that have a realistic risk of contamination by Mollicutes (including the genus Mycoplasma). read more
Should You Implement Continuous Real-Time Microbial Air Monitoring?
When properly integrated through appropriate design planning, validation and alignment with regulatory expectations, continuous monitoring can strengthen contamination control strategies and support the consistent production of safe sterile medicines. read more
Establishing Risk-Based Acceptance Criteria for Microbial-Control Hold-Time Samples Across the Biomanufacturing Lifecycle
Current practice is to apply uniform hold times across the manufacturing process, but this causes operational constraints and insufficient microbial control. read more
A Structured Framework for Translating Stage 3b Data Signals into Actionable Intelligence
In commercial manufacturing, the level of effort and assessment need to be proportional to the identified risk. read more
Regulatory Pseudoscience – Myths, Opinions and Other Fantasies
When regulations contradict the natural laws of science, they may impose a substantial hardship on manufacturers. 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: The Benefits of Employing FTIR, RAMAN and NIR Spectroscopy in Your Lab
Many of today’s plastics are multi component systems with multiple constituents like different polymers, fillers, plasticizers and compatibilizers. 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: Challenges in Developing and Manufacturing Biologics - Controlling Quality and Efficacy
This comprehensive eBook provides information on biomanufacturing and biotherapeutic drug development including; aseptic fill-finish of biologics, process analytics with NMR and monoclonal antibodies and more. 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

Validating Automated Alternative Rapid Sterility Methods
This webinar will provide an overview of the on-site validation approach used by Rapid Micro Biosystems™ to demonstrate that the Growth Direct® Rapid Sterility System, is equivalent or non-inferior, to the compendial sterility test described in the ... read more
Engineering for equivalency: Building reliable, optimized facilities
As biomanufacturing grows more complex, the need for facilities that deliver both speed and reliability has never been greater. In this webinar, you will learn how Samsung Biologics' optimized manufacturing framework and a centralized design ... read more