Validation Implementation Services

Our validation team partners with biopharmaceutical manufacturers to manage the digitization process and meet stringent regulatory requirements. Our goal is to help our customers validate the Growth Direct system for full routine use faster. Our high touch service model combines expert validation services supported by an 18/hr 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 includes all the 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 into your laboratory information management system (LIMS) for seamless connectivity. Data from your Growth Direct System® can be directed to different LIMS systems and other networked programs (e.g., environmental monitoring trending databases). Growth Direct creates a standard export file in .csv format that can be parsed by the networked program to pull relevant data.

Secure Networking Options

In addition, Rapid Micro Biosystems validates the remote monitoring software. A third-party security audit is performed on the Remote Monitoring System (RMS) Server.

Simplified, Tailored Training Options

Custom training is available for microbiologists to quickly adopt the Growth Direct system. Sessions are tailored to your team requirements, and support for feasibility studies and test protocols is available.

Validation Approach

Rapid Micro Biosystem's validation approach has been proven in use 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 a growth media that shows viability of microbial cells through growth, as required in the Pharmacopeia.

  • For environmental monitoring, the only consumable difference is the presence of a membrane on the media surface.
  • For water/bioburden testing, the consumables are equivalent to the traditional method.

The performance testing of Growth Direct 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.