Even though most pharmaceutical water systems are controlled, water testing comprises a significant percentage of the workload in a quality control (QC) micro testing lab.
Each water sample test is divided into two phases:
The second phase often involves highly trained analysts performing the repetitive, time-consuming task of data collection and collation, for which they may be overqualified.
Growth Direct™ automates the incubation, reading, and recording of water testing sample results. It can be linked to a two-way laboratory information management system (LIMS) to upload sample work lists and download results.
The result: Growth Direct greatly reduces the time required of analysts, freeing them to do other essential work.
In addition to reducing workload, Growth Direct yields faster results. Typically, results can be obtained in 96 hours rather than the 7 days used in the traditional in-house method. For faster-growing organisms, a positive result can be seen in as little as 20 hours.
Sample preparation is 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 the cassette is loaded into Growth Direct, the system does the rest of the incubation, analysis, and reporting.
The media types are familiar too: 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.
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.