A sterility pass is a real result about a real endpoint — but it's not the endpoint most people assume it is.
Sterility testing checks a product sample for viable microorganisms — bacteria and fungi — by incubating it in growth media and watching for growth over a defined observation window, commonly up to 14 days under compendial methods. If nothing grows, the result is reported as "no growth" for that sample.
That's a genuinely useful result. Microbial contamination in an injectable cellular product is a serious safety issue, and a documented, independently run sterility test is one of the ways a manufacturer demonstrates it isn't shipping contaminated material.
A "no growth, Day 14" result is a statement about microorganisms. It is not a statement about:
The confusion isn't usually intentional — a professionally formatted document with third-party lab letterhead simply reads as authoritative. But a provider reviewing supplier documentation should confirm that each claim — sterility, viability, identity, count — is backed by its own labeled result, rather than assuming one passing test covers the others.
ATOM lots are released with sterility results from an independent third-party laboratory, reported on the Certificate of Analysis alongside — not in place of — viable cell count and viability. Each result is labeled for what it actually tests.
View a Sample COAThis page is educational reference material for licensed healthcare providers and does not constitute medical, legal, or regulatory advice. HCT/P products are not FDA-approved.