Making light work of QC micro for regulated manufacturing
Manufacturers for the pharmaceutical and biotech industries are required to carry out and report QC microbiology testing (QC micro). Many manufacturers’ processes for QC micro testing are manual, creating considerable opportunity for error. ‘From scheduling through to sample collection, testing, and results analysis and reporting, the majority of stages involve manual input of data, either onto paper or into spreadsheets,’ explains Michael Goetter, general manager for informatics at Lonza Bioscience. Trained personnel could thus effectively spend many hours a day on just inputting data and results into spreadsheets, databases, and reports. ‘This reliance on manual processes represents a major expenditure in time for personnel, but also creates numerous real and potential compliance errors.’
A more efficient QC micro process
As part of a move to improve efficiency and reduce manual error in its QC micro organization, in 2009, three cleanroom facilities at Lonza Walkersville, a global custom manufacturing and development site for the pharmaceutical and biotech industries, were tasked with trialling MODA Technology Partners’ MODA mobile data acquisition and software platform, a dedicated system for automated, paperless, QC processes. MODA had been developed by Goetter and partner Steven Melick, and their company, MODA Technology Partners, was established in 2006 with venture capital funding to commercialise the system for QC micro in the pharmaceutical, medical device and veterinary medicine sectors.
Implementation of the MODA platform at Lonza Walkersville effectively eliminated the manual steps in the QC micro process, and within a year it was evident that the system had enabled a high level of cost, procedural, and manpower-related efficiencies. Following upgrade of the system at Lonza’s request and its roll-out to additional Lonza global sites, the company bought out MODA Technology Partners in 2010. ‘Lonza Bioscience’s testing customers were QC, our main customers were QC, and so it was a very complementary fit, particularly on the microbiology side, to their offerings within quality control,’ Goetter states.
A complete solution
The MODA platform is now offered by Lonza Bioscience as a complete solution for QC micro that encompasses enterprise software as well as mobile computing hardware, to provide a completely paperless and automated process for the planning, scheduling and execution of QC micro testing, and the collection, analysis and reporting of results, combined with trend analysis and advanced data visualisation tools. The solution covers all environmental monitoring (EM), utility testing, and product testing workflows.
‘MODA does truly capture the entire sample life cycle for QC micro, and completely paperlessly,’ Goetter claims. ‘From the initial barcoding of each sample, there is effectively no manual data entry, the operator can directly capture data electronically in the clean room, and they are walked step by step through the standard operating procedures (SOPs) as tests on the sample are carried out. Personnel are automatically alerted if there are any critical events, and a whole suite of analytical and ad hoc reporting tools and validated report formats are built in, combined with dynamic visual maps that can highlight if there are any issues in a clean room or water system, for example.’
Ideally suited to aseptic and controlled manufacturing
MODA is ideally suited to aseptic and regulated manufacturing operations because of its ability to handle and analyse potentially hundreds of thousands of location-dependent, rather than batch-centred environmental samples, Goetter continues. ‘These may include, for example, high-volume environmental sampling of water and gases. The location-centred nature of the QC micro workflow and data analysis is something that a traditional laboratory information management system (LIMS) will struggle to manage without considerable, and costly, customisation.’
Historically, LIMS systems have been more geared towards quality control chemistry rather than microbiology, Goetter believes. ‘They haven’t been very good at managing microbiological evaluation tests, or the volume of testing required, and LIMS scheduling is usually batch-based rather than location-centred. A LIMS is also unlikely to offer dynamic maps of a clean room, or other visualisation and trending capabilities that are part of the MODA package’.
Integration with LIMS
MODA can be integrated with an existing LIMS system seamlessly, using the software’s application programming interfaces. Goetter describes the platform as an essential part of an organisation’s quality systems portfolio. ‘MODA is a cost-efficient, out-of-the-box product that will integrate with a LIMS at key data points, such as producing a batch record. For example, when batch-test chemistry results are loaded into an existing LIMS, MODA can add in the micro testing data to complete a batch record for full reporting. The MODA system effectively enables a much greater business value to be derived for QC micro environments, without having the upfront and ongoing support costs of customising an existing LIMS or informatics infrastructure.’
Critically, the MODA platform includes cleanroom-compatible hardware, and it is this combination of hardware and software that has allowed MODA to be developed as a completely paperless system, Goetter stresses. ‘Hardware includes sanitisable tablets, barcode printers, and scanners, trolleys, and associated equipment. We’ve done the difficult bit, which is to bring computing resources into a clean room. You have to have very durable and mobile equipment that can withstand heavy chemical sanitisation, that can move with the operator as they take samples, and that offers features such as offline functionality. You can do everything electronically, right from the point of sampling through to results analysis, trend analysis, and reporting.’
Expansion into biotechnology and bioprocessing
Lonza is working to evolve MODA further beyond QC micro, into areas including biotechnology and bioprocessing production, Goetter comments. ‘Within a few years we hope to launch major improvements to both the test execution and analytics portions for QC micro, but also an expansion with respect to other laboratory execution functions within regulated manufacturing. In addition, we are using the resources of the Lonza organisation to increase our global footprint from our core geographies of North America and Europe, particularly as clients roll out MODA into their own global facilities. Over the past five years MODA has become the standard for QC micro for a number of global pharmaceutical and other regulated manufacturing organisations. We understand the needs of the QC micro organisation because we have that expertise in the field, and we’ve focused on deriving value out of a very low cost of ownership, for both the IT departments and the end users.’