Bioburden Testing


Bioburden testing with results in half the time...automatically

Growth Direct™ automates bioburden testing and analysis. Growth Direct automatically provides incubation, enumeration, reporting, and integration to your laboratory information management system (LIMS).

Growth Direct reveals positive results within hours of testing and delivers final results in about half the time of a typical test. Bioburden testing results are provided in colony forming units (CFUs).

With Growth Direct, the time to results for bioburden and water testing is set after running the USP microbes and any in-house isolates during validation.

Simple sample preparation

You’ll find sample preparation very easy. Samples filter through the 0.45 micron funnel on standard vacuum manifolds. The funnel easily breaks away to allow access to the filter membrane, which is transferred to the media cassette. Once you load the cassette into Growth Direct, the system does the rest of the incubation, analysis, and reporting.

The media types are also familiar: R2A, TSA, and SDA.

Cassettes come prelabeled with a unique 2D identifier barcode. The cassette also accommodates a system-generated, customer-applied label with an additional 2D barcode for sample identification.

Growth Direct is non-destructive because it uses no reagents. Positive samples can continue to incubate and be sent to a microbial identification system for further analysis.

Easy to validate

By automating the compendial method, Growth Direct simplifies validation.

It adopts the identical media and consumables used in the compendial method. The only difference: shorter incubation time. 

The technology and validation approach should be considered "Automated Compendial" as defined by the PDA Technical Report 33 (TR33) and USP 1223, which state that validation consists of accuracy and precision testing of the enumeration accuracy and should be performed in addition to method suitability or an equivalence/comparability study. 

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