Starting December 1, 2025, USP will, for the first time, define clear requirements for bioburden with the new chapters <1119> “Bioburden Monitoring” and <1119.1> “Bioburden Test.” These chapters cover non-sterile, sterile, and low-bioburden manufacturing processes.
In contrast to USP <61>, which focuses on finished products, the new chapters place manufacturing processes at the center: risk assessments of microbiological contamination sources, preventive measures, and factors such as storage conditions, holding times, and bioburden-reducing process steps.
The USP chapters also clarify FDA expectations and are closely aligned with European requirements (EU GMP Annex 1, EMA Guideline). The shared goal: risk-based bioburden monitoring and maximum patient safety.
With many of the required tests already established in our labs, we are well prepared to support you – from risk assessments and study design to complete documentation. This way, you benefit from a one-stop solution and our expertise in risk-based bioburden monitoring.
Labor LS SE & Co. KG
Mangelsfeld 4, 5, 6
97708 Bad Bocklet
Germany
