With our established laboratory services in microbiological testing, we already support pharmaceutical and biotech companies in implementing modern bioburden strategies – including preparation for upcoming regulatory requirements.

On December 1, 2025, the United States Pharmacopeia (USP) will introduce specific requirements for bioburden for the first time. These are described in the new chapters <1119> “Bioburden Monitoring” and <1119.1> “Bioburden Test”.

The new requirements apply to manufacturing processes for non-sterile, sterile, and low-bioburden products.

While the existing USP chapter <61> primarily focuses on the microbiological testing of finished products, the new chapters place greater emphasis on the manufacturing process itself. This includes risk assessments of potential microbiological contamination sources, preventive measures, and the evaluation of factors such as storage conditions, hold times, and process steps designed to reduce bioburden.

In addition, the new USP chapters further clarify FDA expectations and align closely with European regulatory requirements, such as EU GMP Annex 1 and the EMA guideline on sterilisation. The overall objective is a consistently risk-based approach to bioburden monitoring, with maximum patient safety as the guiding principle.

As many of the required tests are already established in our laboratories, we are well prepared to support you – from risk assessment and study design through to complete documentation of results.

Benefit from an integrated solution and our expertise in risk-based bioburden monitoring.