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.

CIP Failures Due to Biofilm Formation: Strategies for Prevention and Remediation
The aim of a Clean-in-Place (CIP) system is to remove all undesirable materials from product contact surfaces to a level such that residues remaining are of minimal risk to the safety or quality of the product. While the general focus is on the removal of product residues or chemical residues, there is often a microbial control element involved. ... read more
Pharmaceutical P.I.N. Points: Patent Innovation News
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in December, 2024. read more

Evaluating Rapid Microbial Methods - A Comprehensive Approach to Testing with Microorganisms
In the ever-evolving landscape of microbiology and quality control, Rapid Microbial Methods (RMMs) have emerged as powerful tools for detecting and enumerating microorganisms in pharmaceutical manufacturing, food and beverage testing, and environmental monitoring. read more
Executive Q&A: Samsung Biologics
Samsung Biologics continues to introduce new and innovative technology platforms with high-performing solutions that enhance therapeutic efficacy and proactively address evolving industry trends. read more
Whitepaper: Disinfectant Efficacy in cGMP-Compliant Pharmaceutical Manufacturing Settings
The FDA’s intensified onsite inspections of drug production post-pandemic have underscored the importance of robust cleaning- and disinfectant-validation programs. This whitepaper focuses on the importance of disinfectant validations based on real-world conditions to maintain cGMP compliance. It discusses the current lack of ... read more
Container Closure Requirements: Preparing for Updates to USP <382>, <661.1>, and <661.2>
This article will give a comprehensive overview of the evolving container closure requirements for parenteral products and insightful exploration of the alterations introduced by USP <661.1>, <661.2>, and <382>, equipping pharmaceutical manufacturers with the essential knowledge to navigate the evolving regulatory compliance standards effectively.... read more
App Note: To GMP or not to GMP? That is the (PLASMID) question
As drug manufacturers work to secure plasmids for discovery, clinical, and commercial applications, the question looms: how can you maintain a manageable budget while procuring a high- quality plasmid supply? Though opting to begin with a GMP-grade plasmid platform – as opposed to GMP-lite – may initially seem the more ... 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

Improving Environmental Monitoring Sampling Workflows Through Paperless Operations
Paperless sampling operations offer opportunities for more standardized documentation practices and streamlined EM workflows, improving documentation management, transcription accuracy, process visibility, and review efficiency over traditional paper... read more
Cleaning & Disinfection in Biopharma: Cutting Contamination Risk
As biopharmaceutical processes become more biologically complex and operationally interconnected, the impact of contamination events continues to grow. Cell and gene therapies, multiproduct facilities, single-use systems and accelerated timelines ... read more
Implementation of Global Microbiology QC Automation at Amgen
In this webinar learn how Amgen transformed its global QC Microbiology operations by implementing the Growth Direct® platform to fully automate in-process bioburden, water bioburden, and environmental monitoring testing. read more