Innovotech Labs now offers USP <64> Microbiological Examination of Probiotics to support Natural Health Product manufacturers in demonstrating product quality, safety, and regulatory compliance.
With deep expertise in microbiology and product performance testing, our team delivers reliable enumeration,detection of specified microorganisms and contaminants in probiotic products — helping you bring compliant, high-quality products to market with confidence.
USP <64> is a compendial method used to enumerate viable probiotic microorganisms and detect specified contaminants. It helps demonstrate that your product meets quality, safety, and label claim requirements for regulatory and commercial acceptance.
Yes. We develop recovery strategies tailored to your specific strains and formulation to ensure accurate enumeration, even in complex, multi-strain products.
Absolutely. Method suitability confirms that the test method can accurately recover microorganisms from your product matrix, which is often required for regulatory compliance.
Yes. USP <64> testing is commonly used to monitor probiotic viability over time under various storage conditions to support shelf-life claims.
One consistent trend we see is clients struggling to hit their colony forming unit (cfu) specification, often seeing a lower overall yield than expected. We support clients with root cause analysis and have often traced the issue to input cultures having a lower potency then expected from the supplier’s CofA. If you are using input cultures sourced from a third party, we highly recommend verifying the potency of these cultures via testing, not just working off the supplier’s CofA. Often, as these cultures are sourced and moved through supply chains there is a decrease in potency from the supplier’s original CofA.
