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Validation Services

Our validation team partners with pharmaceutical manufacturers to manage digitization, provide documentation support, assist with LIMS integration and networking, and meet stringent regulatory requirements.

Fast, Efficient Implementation Support

As acknowledged experts in this Rapid Microbial Method (RMM), our goal is to help qualify the Growth Direct® System as efficiently and quickly as possible, typically in just four months. Our high-touch service model combines expert validation services and an 18-hour-per-day support line, with no need for a triage process.

Support begins prior to system purchase, when our sales representative brings in a validation expert for consultation about specific application requirements. The validation teams offer a complete array of documents and services to support validation efforts. This covers all steps in the validation process, including:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • 21 CFR Part 11 Assessment
  • Method Qualification/Method Suitability (MQ/MS)
  • Bi-directional Software Integration to LIMS

With our universal communication platform, we work with your information technology (IT) team to integrate the Growth Direct® System's software into your laboratory information management system (LIMS) for seamless connectivity. Data from the Growth Direct® System can be directed to different LIMS systems and other networked programs (e.g., environmental monitoring trending databases), creating a standard export file in .csv format that can be parsed by the networked program to pull relevant data.


Secure Networking Options

Rapid Micro Biosystems validates the remote monitoring software, and a third-party security audit is performed on the Remote Monitoring System (RMS) server.



Simplified, Tailored Training

Custom training is available to help microbiologists quickly adopt this Rapid Microbial Method (RMM). Sessions are tailored to your team requirements, with available support for feasibility studies and test protocols.

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Proven Validation Approach

Our approach has been used at many pharmaceutical sites that have received regulatory approval to perform environmental monitoring, water testing, and bioburden testing with the Growth Direct® System. The system performs automated cassette incubation and colony enumeration and reporting using a media cassette, which contains growth media that shows viability of microbial cells through growth as required in the Pharmacopeia.

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System Performance Testing

Performance testing of Growth Direct® System consumables is identical to standard media plates, as defined in the US Pharmacopeia Ch<1223> and European Pharmacopeia microbiology chapters 5.1.6. The key system components to validate are:

  • The two incubators on the system (calibration and mapping)
  • The optical enumeration system and the electronic data transfer (if used)

As an automated colony counter, the validation requirement as defined in the PDA Technical Report 33 (TR33) will only be the accuracy and precision of the system compared to the reference standard, which is the analyst count. These two requirements are the same as for the validation of standard microbiology methods when spike and recovery experiments are performed. Precision is required to provide good estimates of colony forming units (CFUs) to compare to the control inoculation to determine accuracy.

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