In the high-stakes world of pharmaceutical quality control, a single undetected contamination can compromise patient safety, and trigger costly regulatory investigations. Yet many QC microbiology labs continue to struggle with outdated testing methods, inconsistent results, and mounting compliance pressures. Labs are expected to deliver accurate results faster than ever before – all while maintaining the highest standards of quality and compliance.
Mycoplasma contamination remains one of the most significant challenges to cell culture integrity, as it can compromise entire batches before detection. The upcoming Ph. Eur. 2.6.7 MYCOPLASMAS revision will demand even stricter quality requirements – here's how to be ready. Advanced detection kits like MycoDetect are revolutionising contamination screening with 1-hour results, targeting the highly conserved 16S-rDNA region, with broad species coverage, and built-in controls that eliminate guesswork. identify even low-level contamination quickly, accurately, and confidently using this real-time qPCR technology. Meanwhile, Minerva Biolabs' Venor® detection systems continue to set the gold standard with sub-3-hour detection times – trusted by industry leaders for over 25 years.
The upcoming revision of the Ph. Eur. 2.6.7 MYCOPLASMAS will specify quality requirements of mycoplasma strain preparations for the validation of nucleic acid amplification techniques. Mycosafe® Mycoplasma Culture Reference Standards are ready-to-use low-GC/CFU cell suspensions of mycoplasmas in the mid-log growth phase.
One of the main issues in pharmaceutical manufacturing is maintaining sterility during material transfer into cleanrooms and critical zones which is also a key focus of the updated EU GMP Annex 1. The Redipor® line of TwistLock plates and BetaBag ready-to-use media supports sterility assurance from transfer to sampling, enabling you to confidently meet Annex 1 requirements.
Advances in respiration-based testing can transform how pharmaceutical labs approach microbial detection. The new USP <72> chapter opens doors to faster, more efficient testing using cutting-edge BACT/ALERT® 3D technology – delivering results that traditional methods simply cannot match. But speed means nothing without accuracy.
Watch the webinar where Rapid Micro Biosystems' team discusses how Lonza has successfully integrated the MODA-EM® Module with the Growth Direct® System, combining paperless processes with automated microbial enumeration for pharmaceutical QC.
Whether you're implementing traditional protocols or embracing rapid methodologies, EZ-Accu Shot™ delivers pre-enumerated organisms designed for seamless integration with compendial sterility testing (USP <71>) as well as upcoming rapid microbiological methods (USP <72> and <73>), including ATP bioluminescence and respiration-based detection.
Viscous samples complicate bioburden testing, material transfer protocols face increased scrutiny during inspections, a specialized approaches needed to ensure compliance with pharmacopeial standards. The Microsart® filtration system provides a tailored solution for these challenges.
Will you continue struggling with outdated methods, or will you embrace the technologies that are reshaping pharmaceutical microbiology?
Discover how leading QC labs are achieving faster results, ensuring compliance, and protecting product integrity – all while reducing costs and improving efficiency. Explore this rapidmicrobiology special focus, a curated page focused on products available now on the market, to help you have confidence in your sterility testing results.
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