QC Microbiology for Pharmaceuticals - a rapidmicrobiology Special Focus

Ready to revolutionize your sterility testing program? How do you eliminate supply chain bottlenecks that impact your entire operation? In this special focus, discover:

  • Compendial testing solutions from global industry leading suppliers.
  • How to dramatically reduce sterility and bioburden testing timelines.
  • Choose the most appropriate RMM for your processes.
  • Connect with providers via our 'Request Information' form on each product page.

Need to ensure excellence in critical quality control? Experience the confidence that comes from working with industry leaders who understand the issues. 

In this special focus, you can discover how bioMérieux supports pharmaceutical manufacturers with fast, reliable QC solutions that enhance safety, efficiency, and compliance, helping labs optimize processes and make smarter decisions across their workflows. Liofilchem offers a wide range of solutions for detecting microorganisms in raw materials, water, air, and final products, using devices for environmental monitoring and product release.

Puritan ESK Environmental Sampling Kits ESK® will assure you that your surfaces are free of contaminants, safe, and ready for production. ESK® includes an integrated, smaller swab for sampling hard-to-reach spots and is available in four solution options, with two fill level options.

Under the Redipor® brand, AnalytiChem's Trusted formulations include TSA with neutralisers, TSB in single and double-strength formats, and specialist sterility testing kits, supporting routine QC activities across sterile and non-sterile manufacturing.

The ScanStation® from INTERSCIENCE supports rapid microbiology workflows by combining controlled incubation with continuous, automated imaging, enabling earlier detection of microbial growth compared with traditional end-point incubation methods. 

Designed for GMP environments, ScanStation® improves standardization and traceability while reducing manual plate handling and subjective readings. Digital records and time-stamped images support data integrity, deviation investigations, and microbiological trending programs, helping QC teams make faster, more confident decisions without compromising compliance. 

The newly updated General Chapter 2.6.7. Mycoplasmas, which has just been published in Issue 12.2 of the European Pharmacopoeia and will enter into force on 1 April 2026, has specified exactly the quality requirements for mycoplasma reference standard preparations. The section on Nucleic acid amplification techniques (NAT) has been extensively revised to reflect the state of the art in science and technology. A limit of less than 10 is now proposed as the acceptance criterion for the GC/CFU ratio of reference preparations, unless otherwise justified. To help you navigate these regulatory changes and support your quality control efforts, Merck offer Mycosafe® Mycoplasma Reference Standards.

Based on a biocalorimeter platform, the Symcel calScreener+ Sterility system detects microorganisms via their metabolic heat, enabling rapid and highly sensitive growth-based detection of viable contaminating microorganisms. In an upcoming webinar, Symcel will present the latest developments and validation data for the calScreener+, designed to support sterility test release in three days or less. Included will be examples from data presented by Johnson & Johnson comparing time-to-detection using the calScreener+ system for sterility testing, and the implementation of calScreener+ as an alternative rapid microbial method in cell and gene therapy manufacturing processes. Implications of USP safety margins for slow-growing organisms such as C. acnes, and how calScreener+ enables growth-based testing with a release time of 3 days.

Biotactical combines ATP bioluminescence with accelerated growth media and supports complex, short-shelf-life products, including ATMPs, where traditional sterility testing creates release risk and lost treatment windows. The solution is designed for GMP environments and aligns with USP <71>, USP <73>, USP <1223> and Ph. Eur. 2.6 and 5.1.6.

Alpha Laboratories offer the new RiboNAT™ rapid sterility test by FUJIFILM Wako. Using the Nucleic Acid Amplification (NAT) method, targeting ribosomal RNA (rRNA) and using RT-rPCR to deliver accurate results in just 7 hours. This test method boasts numerous benefits compared to other sterility tests. 

Recently acquired by bioMérieux, Accellix has developed a compact flow cytometry platform that delivers results in under 30 minutes, enabling real-time quality control during cell therapy manufacturing.  

Even with advanced in-vitro methods, endotoxin masking remains a key challenge that can lead to false-negative results and compliance risks. Lonza’s PyroCell® MAT Systems provide a sustainable alternative for detecting endotoxins and non-endotoxin pyrogens. Lonza offers flexible, validated system options designed to meet product-specific and sustainability requirements. These systems utilize human immune cells to deliver accurate and reliable results, supporting testing of complex biologics, including vaccines and gene therapies. 

In a collaborative study conducted by Lonza and Solvias, the teams demonstrated how PyroCell® MAT, combined with the PYROSPERSE® Dispersing Agent, can enhance pyrogen detection in challenging matrices. For teams looking to better understand endotoxin masking and its impact on MAT performance, the on-demand webinar “Disrupting endotoxin masking in the Monocyte Activation Test” provides practical insights grounded in this study and real-world testing experience.

Plus, you'll find details of an on-demand webinar from Clever Culture Systems that explores the advantages of AI. Learn how it can elevate your environmental monitoring by increasing throughput, reducing subjectivity, and upholding regulatory compliance.

Long incubation times delay critical QC decisions. Learn how real-time incubation and automated colony detection can accelerate contamination detection and improve efficiency in pharmaceutical microbiology labs.
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bioMérieux supports pharmaceutical manufacturers with fast, reliable QC solutions that enhance safety, efficiency, and compliance, helping labs optimize processes and make smarter decisions across their workflows.
Find Out More
 
The Ph. Eur. Mycoplasmas chapter (2.6.7) updates, effective April 1, 2026, set new quality requirements and acceptance criteria for mycoplasma reference standards. Mycosafe® offers compliant, ready-to-use solutions for accurate testing.
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Puritan® single-use swabs and surface testing kits are designed for use in the most challenging of environments, helping to assure that manufacturing surfaces are clean, free of contaminants, and ready for production.
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QC labs face pressure to meet sustainability goals without sacrificing performance. Learn how MAT-based testing supports pyrogen detection - and explore a Lonza webinar with practical insights on overcoming endotoxin masking.
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As pharmaceutical processes become more complex, QC microbiology remains the defining safeguard for patients. But exactly why does dependable, consistent microbiology still matter so much for modern QC labs, and what solutions are available?
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Gain an understanding of how AI-driven alternative micro methods can support environmental monitoring workflows and what’s required to confidently adopt and validate - including real-world insight into evaluation approaches and regulatory expectations. 
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Liofilchem offers a wide range of solutions for detecting microorganisms in raw materials, water, air, and final products with its devices for environmental monitoring and product release, preventing microbial contamination.
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Join this Symcel webinar to learn about the latest developments in rapid, growth-based sterility testing for cell and gene therapies, enabling release in three days or less through biocalorimetry.
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More News

48 Hour Sterility Testing for Faster Pharmaceutical Batch Release

bioMérieux Acquires Accellix to Elevate Pharmaceutical QC and Accelerate Advanced Therapies

Introducing RiboNAT™: A New Rapid Sterility Test Designed for Super-fast Results

Events

Webinar: Advancing 3-day Sterility Testing for Cell and Gene Therapies

Cell and Gene Therapy International

 
2026 QC Micro Summit
It’s the one event developed by your industry peers who know how hard it is to get out of the lab. It’s an event aimed at letting you step away from the bench, learn about the big trends impacting our industry, share ideas, and develop new professional relationships across the industry.
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Validate Your 2nd Culture Media Supplier and Eliminate Single-Source Risk
Join this webinar, hosted by rapidmicrobiology, to hear from specialists at Pharmamedia Dr. Müller GmbH, NPC and GDM Pharma consulting as they share practical insights on why and how to validate a secondary culture media supplier.
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