The closed-canister approach to membrane filtration has made sterility testing in laminar flow hoods, isolators, and cleanrooms easier to perform. However, avoidable errors, such as mistakenly using out-of-date consumables, can still occur. Also, documentation issues such as not following written procedures are a growing concern and feature among the main reasons for FDA citations. Here, we ask Yoann Mainguy, Global Product Manager Sterility Testing at Millipore SAS, France, to share his extensive knowledge and experience in satisfying regulatory requirements for traceability in sterility testing and to explain why the new M-Trace^® solution is a game changer for any lab performing this QC test.

Q: Which QC tests are the M-Trace^® solution intended for? What does it do?
Yoann: The M-Trace^® electronic test record solution is designed to support sterility testing by membrane filtration when using Steritest^® Symbio pumps. The 21 CFR Part 11 compliant software runs on a mobile computer and the app on a handheld device similar to a smartphone. It is compatible with all Steritest^® Symbio pumps, even older ones, which require only minor upgrades.

The M-Trace^® solution can eliminate difficult-to-track paper trails and help meet the ALCOA+ principles that require recorded data to be attributable, legible, contemporaneous, original, and accurate. During each sterility test, the M-Trace^® software gives step-by-step handling instructions, either on the pump’s display or by voice, while capturing all relevant test data in real time, for example, on consumables, samples, the technician, and pump parameters. After each workflow step, the technician gives feedback to confirm that it has been followed correctly by either voice or pressing a button on the pump.

Q: How does the M-Trace^® platform help with regulatory requirements?
Yoann: The M-Trace^® system offers a convenient and reliable way to comply with regulatory requirements regarding traceability and data integrity. When performing sterility tests, technicians usually have no direct access to their computers or to written documents, as they must avoid touching anything that could lead to contamination. They can, therefore, not document the testing steps they perform in real-time, a procedure the ALCOA+ principles require to demonstrate that a test has been performed according to the SOPs. The auditable data that the M-Trace^® software records helps to generate comprehensive reports for QA review and approval. By giving step-by-step guidance and recording data automatically in real-time, the M-Trace^® solution makes complete data trails, data integrity, and regulatory compliance much easier to achieve than ever before.

Why is having full control and traceability of the pump’s parameters critical for sterility testing?
Yoann: The pump’s speed is an important parameter. It can have an effect on the splitting of the sample into the two canisters, on rinsing efficiency and ultimately on the growth of colonies on the culture media, so the pump speed has to be set according to the validated SOP. Pump pressure is another parameter that should be recorded by the M-Trace^® software. The data to capture are determined when initially translating the existing SOPs into customizable digital workflow steps.

How do facilities start integrating the M-Trace^® Software and Mobile App? What validations are needed? How can Merck help?
Yoann: All that users should do is install the software and plug in the pump. The M-Trace^® software can also be installed in Windows and integrated into the customer’s IT environment, allowing the reports it generates to be transferred to, for example, a LIMS. The key initial step is to translate the existing SOPs into digital workflow steps and to determine which data are to be recorded at which point. Merck can help with the installation, integration, and validation of the software and provide services for SOP translations and the transfer into the M-Trace^® software

Can the M-Trace^® system be used with consumables from any supplier?
Yoann: Yes, the mobile device can scan any barcode or QR code, no matter from which supplier. If a consumable does not have one, the barcode generation and print module in the M-Trace^® software can serve to create one.

What benefits does the M-Trace^® solution offer over other available options?
Yoann: Most facilities still base their QC data management on a combination of paper documents, spreadsheets, and digital tools for individual instruments. Manual documentation can be incomplete or contradictory, data entered into the wrong field or saved in the wrong place—the list of potential errors is long. Very often, this is due to manual documentation being delayed. Because it records data automatically and contemporaneously, the M-Trace^® software increases trust in the recorded sterility testing data and improves traceability, which facilitates out-of-specification investigations if required. It saves a lot of the time needed for documentation and its management. Thanks to M-Trace^® software’s step-by-step guidance principle and the deviation alerts it gives, the likelihood of human handling errors is reduced, and it becomes easier to train new staff members.

Is the system suitable for worldwide deployment? Is it multilingual?
Yoann: Yes, the 21 CFR Part 11 compliant M-Trace^® software can be used in the languages English, German, Spanish, Italian, French, Japanese, and Chinese.

Learn how the M-Trace^® software can fill the data integrity gap in sterility testing.

About the Interviewee

Yoann holds a degree in biology and biotechnology and has more than 20 years of experience in industrial microbiology. He has spent 15 years in different QA / QC roles in the Biomonitoring division of our company, covering our complete Pharmaceutical QC portfolio. In 2019, Yoann joined the Marketing organization as Product Manager for Sterility testing and Mycoplasma testing solutions, focusing on microbiology and quality control, including compendial, alternative and rapid methods.