Microbiologics Acqui...
Navigating the New USP <72> and <73>: Growth Promotion Testing with EZ-Accu Shot™
The upcoming updates to the United States Pharmacopeia (USP) introduce chapters 72 and 73, which become official on August 1, 2025. These new standards focus on rapid microbiological methods (RMMs) for detecting microbial contamination in short-life pharmaceutical and biopharmaceutical products. While these advancements emphasize speed and automation, growth promotion testing (GPT) remains a critical component of quality control testing and regulatory compliance.
As manufacturers prepare for these changes, the need for reliable, ready-to-use microbial reference materials for GPT is more important than ever. EZ-Accu Shot™ provides a standardized and convenient solution that ensures culture media performance while simplifying workflows.
What to Expect with USP <72> and <73>
Both USP <72> (Respiration-Based Methods) and <73> (ATP Bioluminescence-Based Methods) introduce new technologies for detecting microbial contamination in short-life products, such as cell therapies and other time-sensitive biologics. These chapters align with the broader industry shift toward faster, more automated microbiological testing to reduce time-to-result and enhance process control.
Despite the adoption of these advanced methods, the fundamental requirement for growth-based confirmation of culture media performance remains unchanged. GPT ensures that culture media can support the growth of a low number of specific microorganisms so you can confidently find microbial contamination.
Key GPT requirements under the new chapters include:
- Use of specific test strains (aligned with compendial standards)
- Inoculation of not more than 100 CFU per test culture media container
- Defined incubation periods (≤3 days for bacteria, ≤5 days for fungi)
- Confirmation that all test strains are detected
Ensuring Compliance with EZ-Accu Shot™
For microbiology labs adapting to USP <72> and <73>, EZ-Accu Shot™ offers a simple, consistent, and compliant solution for GPT.
- Accurate & Reliable – Delivers a precise CFU count to meet the ≤100 CFU inoculation requirement
- Ready-to-Use – Eliminates time-consuming culture preparation and reduces variability
- Broad Compatibility – Suitable for traditional and rapid microbiological methods
- Regulatory Confidence – Traceable to recognized culture collections
By integrating EZ-Accu Shot™ into GPT workflows, labs can seamlessly verify media performance while focusing on implementing RMMs in compliance with the latest USP updates.
As the industry moves toward automation and real-time microbial detection, growth promotion testing remains a cornerstone of quality control. With EZ-Accu Shot™, microbiology labs can confidently conquer USP standards while maintaining the highest level of accuracy and efficiency.
Are you ready for USP <72> and <73>? Learn more about how EZ-Accu Shot™ can support your growth promotion testing needs.
Tags:
Date Published: 11th March 2025
Source article link: View
Microbiologics Acquires SensID, Expanding Expertise