When choosing an alternative rapid sterility testing method over traditional USP <71>, it’s essential to consider several factors that directly impact your testing process. Here’s what to keep in mind when deciding which method best suits your needs:
SPEED.
Rapid sterility testing methods are designed to provide quicker results, saving up to 90% of the time, compared to traditional USP <71>, which takes 14 days.
- 503As: useful for Category 2 or 3 CSPs with longer BUDs. Not all CSPs require sterility testing, but speed matters most when assigning shorter BUDs.
- 503Bs: sterility testing is mandatory for every batch, so faster turnaround can significantly improve production and release schedules.
REGULATORY COMPLIANCE.
Before adopting a rapid method, ensure it’s accepted by your respective regulatory body, such as the FDA and State Boards of Pharmacy. It’s also important to confirm that the method aligns with your region’s regulatory requirements.
- 503As: Oversight comes from USP <797> and State Boards of Pharmacy. Product specific method suitability is required.
- 503Bs: regulated under CGMP by the FDA. Rapid methods must undergo product specific method suitability.
SENSITIVITY.
The traditional USP <71> method is sensitive and can detect low levels of microbial contamination only if it grows at the level that can generate visually detectable turbidity. Rapid methods may offer comparable or higher sensitivity.
GROWTH-BASED VS. NON-GROWTH-BASED METHODS.
Not all rapid methods rely on microbial growth. Non-growth based method can drastically reduce testing time, however, non-growth based methods may not always produce an organism for narrow group (species level) microbial identification.
TYPE OF PRODUCT.
Not all products are suitable candidates for alternative sterility testing. Highly viscous or oily formulations, products that auto-fluoresce, or materials that are not filterable may be incompatible with the ScanRDI® platform. Therefore, careful evaluation of product characteristics, turnaround time requirements, and selection of an appropriate testing platform is essential.
While alternative rapid sterility testing methods can provide advantages in speed and operational efficiency, these benefits must be balanced against product-specific attributes, regulatory expectations, and method reliability.
Product-specific method suitability testing is critical to ensure sterility testing is appropriate, defensible, and protective of patient safety.
USP <71> | USP <72> Bact/ Alert® | USP <73> Celsis® | ScanRDI® | |
Growth-based method | ||||
Microbial identification | ||||
Fastest release time (business days) | 14 days | 7 days | 7 days | 1 day |
Method Suitability |
Not sure which method is right for your product?
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