Rapid Micro Biosystems and Lonza made a joint presentation entitled MODA-EM Solution and Its Integration with the Growth Direct System for EM Testing at the recent PharmaLab Congress in Dusseldorf, Germany.
The presentation reviewed the challenges facing pharmaceutical microbiology QC labs today: the need for rapid turnaround of sample results to expedite product release and the need to react more quickly to an excursion in the environmental control of the facility.
Factors that delay the generation of results can be associated with:
- The basic restrictions of microbiology, such as the time taken for the organisms to grow on the test materials
- Data recording, review, and transcription to tracking worksheets
- Redundancies required to ensure data integrity
Common laboratory investigations present many challenges. These include a multitude of disparate data points from a variety of samples:
- Air, surface, and water
Another challenge for QC Labs- information residing in multiple locations:
- Sample records
- Laboratory facilities
An innovative solution to these challenges is now available: the integration of Growth Direct™ and MODA-EM™ into the microbiology QC lab.
Growth Direct™ is the first and only growth-based system to automate compendial QC Micro testing. MODA-EM is a comprehensive, dedicated environmental monitoring software package for paperless QC microbiology, including environmental, utility, and product monitoring.
Benefits of implementing Growth Direct and MODA-EM
The combination of the Growth Direct System with the MODA-EM solution facilitates many of the requirements for data security implementation:
- The process—from sample load to incubator, to final report and data transfer to batch records—is performed without the need for manual labor, thus minimizing human error.
- Using the Growth Direct system eliminates any need for a second analyst to verify the count from the first analyst. Once the system has been validated to produce an accurate count, it can generate reproducible accuracy for colony enumeration.
- Data transfer to the MODA-EM system is performed accurately, so there are no issues with transcription errors that can be encountered with a manual process.
- Pre-defined sample collection, data analysis, and easily reviewable data provided by the combined system allow for a significantly reduced cycle time from sample collection to sample release.
- The faster generation of results, transfer to database, and ease of review for trends allow greater control of the quality of the manufacturing environment.
The integration of the Growth Direct System with the MODA-EM solution helps produce substantial return on investment by enabling companies to derive the maximum value from their EM data.
The result: greater ability to make informed and timely decisions in order to meet critical regulatory guidelines.
Learn how Growth Direct can improve accuracy, speed, and efficiency while helping to ensure data integrity in your microbiology QC lab.