USP Chapters 2021 & 2022 Microbiological Testing Updates Frequently Asked Questions
Effective Date: April 1, 2026
1) What changes are being implemented on April 1, 2026?
USP General Chapters <2021> and <2022> are being updated. Key impacts include:
- Total Aerobic Microbial Count (TAMC) incubation extended from 48 hours to 72 hours
- TAMC Suitability testing expanded to include bacteria, yeast, and mold, with acceptable recovery reduced from 70% to 50%
- E. coli detection initial enrichment reduced from 24 hours to 18 hours
2) Why do these changes matter?
These updates strengthen consistency and reliability of microbial results by aligning methods with modern expectations for organism recovery and detection across diverse product matrices.
3) Do previously completed suitability studies still apply?
No. All prior suitability studies must be repeated to meet updated requirements and test conditions.
4) Will my pricing change?
No. Pricing will remain unchanged.
5) When will the new test codes be available?
New test codes will be available April 1, 2026.
6) When are the previous codes being deactivated?
Legacy test codes will be fully deactivated by mid-May 2026.
7) Can we transition early?
Yes. Early transition is available upon request.
8) How will Eurofins support us during the transition?
Eurofins will provide updated suitability guidance, assist with planning, and coordinate sample submissions.
9) How will turnaround times be affected?
TAMC incubation increases may extend timelines, while E. coli enrichment may shorten parts of the workflow. Adjustments will be communicated as needed.
10) What actions should we take now?
Identify affected products, plan to repeat suitability testing, coordinate timelines with Eurofins, and consider early transition.
11) Where can we find additional information?
Resources will be available on our website.
12) Who can we contact with questions?
Click below to connect with an expert.
