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 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

  • An Interview with Ali Mroue and Jay Patel

    “Traditional” methods are viewed as the gold standard, highly recognized, widely regulated, and backed by decades of acceptance, which leaves little external pressure to move away from them. On the other hand, adopting rapid methods requires significant investment in new technologies, extensive validation to meet regulatory expectations, and ... read more

  • Microbial Risk Management in Aseptic Processing - Did Bill Whyte Get it Right?

    This commentary highlights how the advances in technology, risk assessment, and regulatory guidelines have excluded human intervention in aseptic filling, improving both product quality and patient safety. The risk of microbiological contamination during aseptic processing during the past four decades is largely a reflection of technological ... read more
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