manufacturing M
anufacturers 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. ‘Tis 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 soſtware 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
12 SCIENTIFIC COMPUTING WORLD
Making light work of QC micro for regulated
Lonza Bioscience’s MODA system offers not just a paperless but a mobile and sanitisable way to carry out microbiology testing. Sophia Ktori reports
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 Te MODA platform is now offered by Lonza Bioscience as a complete solution for QC micro that encompasses enterprise soſtware 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. Te 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. ‘Tese may include, for example, high-volume environmental sampling of water
@scwmagazine l
www.scientific-computing.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40