Ask Rapid: Validating Water Testing

Answering your questions about water testing and automation with the Growth Direct^® System.

Pharmaceutical water testing is responsible for a large share of the workload in quality control (QC) microbiology labs, particularly those that still use traditional manual processes for sample enumeration, tracking, and reporting. Automating these processes with the Growth Direct^® System can greatly boost staff productivity, freeing highly trained analysts from time-consuming tasks that are also highly subjective and prone to human error. So, in this edition of “Ask Rapid” we’ll address a few common water testing questions.

Is automated water testing comparable in accuracy and speed?
Our studies show that the rapid detection technology and associated algorithms used by the Growth Direct^® System have enumerated microorganism colonies with a level of accuracy comparable to the standard method, with all surveyed microorganisms passing recovery testing. And when it comes to speed, there’s really no comparison. Tests demonstrated that a faster result could be obtained by 96 hours with the Growth Direct^® System, compared to seven days with the traditional control method.

How do I validate water testing with the Growth Direct^® System?
Because the Growth Direct^® System performs as an automated incubation and colony counting system, qualification of the incubators and the colony counting technology are key procedures. Validation can be divided into five steps.

1. Installation/Operational Qualification (IOQ) concentrates on the validation of the system’s hardware and software components to confirm that they are all functioning according to the design specification. This includes the calibration and temperature mapping of the incubators.
2. Performance Qualification (PQ) is subsequently carried out to validate the growth promotion properties of the media in association with the accuracy of colony enumeration by the software.
3. Time to Result Qualification (TTRQ) phase consists of the determination of the timepoint at which the system result is shown to be comparable to the compendial test method. Natural flora from the facility should be tested, rather than the United States Pharmacopeia (USP)/Ph. Eur. organisms that are favored during the PQ. It is also recommended to include some examples of stressed organisms to ensure the worst case scenario for microorganism detection are met.
4. Method Suitability for the product to evaluate interference, either to the growth of the organisms or interference of the product on the detection system of the Growth Direct^® System itself.
5. Verification of Equivalence to the traditional method by running both tests in parallel for a defined period.

Sections 3, 4, and 5 can even be merged into the same experimental design if required.

What kind of validation support can you offer?
Rapid Micro Biosystems has an extremely experienced support team, offering a range of services proven and refined while serving a majority of the world’s top 20 biopharma companies. We can provide:

• On-site installation
• Instrument services
• Validation services (i.e., IOQ, PQ, and Method Validation, including full documentation package and on-site support)
• Regulatory compliance assistance
• Technical support throughout the Americas, Europe, and the Asia Pacific region
• System certification training and new personnel/training refreshers

Where can I learn more?
For extensive data on use of the Growth Direct^® System in water testing, try this article:

• Validation of the Growth Direct^® System to Perform Pharmaceutical Water Bioburden Analysis. European Journal of Parenteral and Pharmaceutical Sciences, Volume 20 Issue 3 (2014)

Have more questions? Contact Rapid Micro Biosystems today. We’ll be happy to discuss ways to modernize your water testing program.