Contamination Control Compass
Edition #01/2026

 

Regulatory Updates
2026 brings movement to quality control

2025 was quite a year for everyone involved in regulatory changes. Between new guidelines, updated pharmacopoeia chapters, and changing expectations, it sometimes felt like the regulatory ground was shifting faster than usual.

Now 2026 is here and with it, several key updates that will directly affect many laboratories.

We’ve summed up what’s coming regarding QC testing and how we’re helping you stay fully compliant from day one.

1. Mycoplasma testing – new EP 2.6.7 requirements (Edition 12.2)

Photo of new EP compliant mycoplasma detection kits and validation standards

From April 2026, the updated European Pharmacopoeia chapter 2.6.7 on Mycoplasma testing takes effect. Many labs are already adjusting their workflows and we’ve made sure you have everything you need.

Alongside our new Venor® Mycoplasma qPCR kit, we’ve released the matching 100GC® Mycoplasma Standards. These lyophilized RNA-containing DNA standards (100 GC/vial) are available for all Mollicute species listed in the EP. They can be used for product-specific validation or as external positive controls.

Together, they offer a complete, ready-to-use solution that simplifies validation and ensures compliance with the new EP chapter.

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See what will change for you

2. Pyrogen testing – the Rabbit Pyrogen Test is history

Photo of animal testing and the alternative pyrogen test method NAT-MAT

Photo animal testing: iStock.com/unoL | Photo horseshoe crab: pixabay.com/Pexels

Since July 2025, the Rabbit Pyrogen Test (RPT) has officially been removed from the European Pharmacopoeia. Marketing authorisation holders had to fully implement this change by 1 January 2026. From this date, pyrogen testing is now risk-based and relies on animal-free methods such as the Monocyte Activation Test (MAT) and the bacterial endotoxins test, with recombinant factor C to be fully integrated from edition 13.1 of the Ph. Eur. onwards.

For anyone now looking for an animal-free and fully compliant comlete pyrogen test, we have a clear answer: NAT-MAT®. This assay combines the established MAT with digital PCR (dPCR) technology. It measures cytokine gene expression (IL‑1β and TNF‑α) for highly sensitive, animal-free pyrogen detection according to Ph. Eur. 2.6.30.

Discover NAT-MAT® products
Read the latest news of EDQM

3. Other regulatory updates worth watching

Photo of female hands working on a laptop and EP publication scedule

Photo: pexels.com/Ron Lach

A few more changes will keep 2026 interesting:

  • Expected USP updates regarding microbial contamination control (<1110> and <1114>), disinfection (<1072>) and mycoplasma NAT testing (<77>)

  • ISO 9001 revision process – TÜV SÜD update

  • New Ph. Eur. general chapter on data quality – EDQM news

  • Extension of implementation period for new regulations – EDQM news

 

Meet us at LabSupply The Hague

We will be exhibiting at LabSupply The Hague on February 10, 2026 – the trade fair for the latest laboratory technologies, applications and equipment. We will answer all your questions about reliable solutions for contamination control.

Admission is free. We look forward to your visit!

 

Product Updates
Looking ahead: what’s next from us

Photo of upcoming products 2026

We’re not slowing down. In 2026, we’ll release additional 10CFU® and 100CFU® Mycoplasma Standards for validation and external controls, as well as brand-new PCR kits for bacteria and fungi/yeast detection.

Each of these products will help you to easily implement regulatory requirements and speed up your product release.

We know that adapting to new standards takes time and careful planning. That’s why we see it as our job to make your transition smoother – with products that are not only compliant, but practical and ready to use. If you have any questions about the upcoming changes or our new releases, we’re happy to help.

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Phone down, hood up: Keep mobile phones out of clean areas. They carry microorganisms and residues that transfer between lab and outside environments, compromising clean work conditions and increasing cross-contamination risk.

 

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Here's to clean cultures and reliable results!


Warm regards,

Your MB Team

 

Do you need technical support or have questions regarding our products? Please contact support@minerva-biolabs.com. Any feedback or suggestions? Write an email to newsletter@minerva-biolabs.com.

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Minerva Biolabs GmbH, Schkopauer Ring 13, 12681, Berlin, Germany

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