Validation of the Growth Direct™ System to Perform Pharmaceutical In-process Bioburden Analysis

Pharmaceutical in-process testing can be a significant percentage of the workload in the microbiological QC department. Each microbial sample test is divided into 2 phases: first sampling/setting up the test and secondly reading and recording the test result(s). The second phase involves a trained analyst performing the very repetitive task of data collection and collation for which they may be overqualified. A reduction in both the time to results, and the analyst involvement on the sample analysis would be a benefit to the micro QC department. Both of which can be obtained by the introduction of automation to this process. Linking automation to a 2-way LIMS system to control sample work-lists and result upload removes time-consuming, laborious tasks from the analyst. 

One avenue that is available to the industry is the use of automated colony counter technology. Micro media plates can be prepared, placed in controlled incubators and colony development monitored and enumerated by the colony counter. Automation allows better control of data and can remove auditor concerns about accuracy of reading, the so called “Four Eyes” requirement.

The use of automated plate readers should not be considered an alternative microbiological test method and subject to full method validation but merely the automation of the incubation and reading of a compendial microbiological method. This view is supported by recent updates to both USP40/NF35 General Informational Chapter <1223> Validation of New Microbiological Testing Methods and industry practice as found in the 2013 PDA Technical Report 33 (Revised) Evaluation, Validation and Implementation of Alternative and Rapid Microbial Methods. Both these documents support a more limited verification of the automated bioburden methods. 

The paper describes the validation of a Rapid Micro Method (RMM) system as an automated colony counter applied to Pharmaceutical in-process bioburden testing. Sample data are given to demonstrate that the technology is accurate at enumerating microorganisms for in-process testing in a biologics facility.

To read the paper, please click here.

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