Previously, we discussed the validation requirements for rapid microbial methods, comparing and contrasting alternative methods from growth-based methods. The validation requirements for alternative methods generally include not only accuracy and precision, but also specificity, limit of detection, quantitation limit, linearity and range. By contrast, growth-based technologies that are considered automated traditional or compendial such as the Growth DirectTM System require validation only for accuracy and precision as part of the overall validation process.
In this installment, we'll dive deeper into the steps prior to and during the installation and operational qualification (IOQ) phase of the validation of the Growth DirectTM System.
Before starting the validation process, to ensure successful installation and operation of the Growth DirectTM System, Rapid Micro Biosystems’ Technical Services team works closely with the local facilities team and will visit the site to confirm delivery and assembly of the technology can occur with no issue and the needed infrastructure is in place to begin qualification as soon as the device arrives.
The pre-installation assessment includes checks to ensure available space exists to accommodate the footprint of the technology, which is around the size of a -80 degree C freezer. In addition, basic checks to confirm the proper operating environment and availability of utilities are performed.
These steps help to streamline the installation qualification process.
During the IQ phase of validation, the Growth DirectTM System is installed and verified for details such as the following:
- Presence of all components and documentation necessary to the system’s operation
- Proper connections to utilities
- Proper connections to networking devices and peripherals
- Installation of additional software as required by the internal IT department
- Secure connection to LIMS (where applicable)
During the operational qualification (OQ) step of validation, specific features and functions are validated according to the requirements of USP <1058> including the following:
- Barcode Scanner: One of the system's benefits is its ability to automatically track and record colony counts based on sample-specific barcodes. Validation includes verification that both the barcode printers and scanners are functioning properly.
- Incubators: The Growth DirectTM System contains two independently operating incubators, each of which are temperature mapped as needed for validation.
- Internal Robotics and Software: Steps are performed to confirm that the software performs as expected with regard to features such as incubation control, temperature management, movement of samples, and 21CFR11 compliance.
Documentation and Support
Rapid Micro Biosystems provides both resources and documentation to help with the IQ and OQ process, as many companies are limited in resources and expertise with validation. Companies that start with the Rapid Micro Biosystems documents and take advantage of our Technical Services expertise find that the IQ and OQ process are more efficient and streamlined.
Still not sure how a growth-based system will benefit your operation? Discover all the ways by downloading the free guide, 4 Benefits of Automated Rapid Detection & Enumeration today.