Clean Facility Roundtable Part 4: Microbial Monitoring Best Practices

Clean Facility Roundtable Part 4: Microbial Monitoring Best Practices

Tuesday, February 19, 2019

The Clean Facility of the Future documentary explores issues surrounding establishment and maintenance of clean facilities for biopharmaceutical reserach through discussions with thought leaders. In this round table series, we ask these thought leaders to expand on topics presented in the documentary. In this fourth roundtable discussion, key stakeholders were asked:

What are some best practices a pharmaceutical company should put in place to collect, store and analyze microbial monitoring data?

Check back to our first roundtable to read about must-have technologies for meeting microbial monitoring requirements, our second roundtable for a discussion on first steps a pharmaceutical company can take to upgrade microbial monitoring, and our third roundtable for a discussion on whether pharmaceutical companies are likely to implement the same strict mircoial monitoring strategies used for sterile products on other types of products.

Claire Briglia
Technology Specialist, MilliporeSigma
Claire Briglia

Many companies have implemented LIMS and electronic notebooks into their facilities. Regulatory inspectors are trained and now expect to see these systems. If you do not have a LIMS, you should be planning to have one very soon. Inspections are so much more efficient if data is easily accessed.

David Jones
Director of New Products & Industry Affairs, Rapid Micro Biosystems
Dr. David Jones

Moving away from paper is an important first element in collecting, storing and analyzing the large amounts of data that is being produced in manufacturing facilities. The next step is to automate the analysis of this data in a secure database that has a full forensic audit trail. The third best practice is to learn from this data and use it to improve the manufacturing and cleaning processes.

Poonam Bhende
Assistant Manager, SGS Life Science
Poonam Bhende

As an independent contract laboratory, our clients are interested in receiving the reports and raw data. In certain cases, SGS also provides trending reports for clients on request.

When clients provide us with specifications, our team can alert them to any OOS so they can take the appropriate action. Then SGS can retest once they’ve resampled.

Félix Alejandro MONTERO-JULIAN
Scientific Director Healthcare, bioMérieux
Félix Alejandro MONTERO-JULIAN, Ph.D.

All data should be traceable to their respective sampling points. Ideally, a barcode system is implemented to ensure any missed plate can be detected. Software allowing the management of the sampling plan, data collection and trending can be very valuable and reduce human error.

Elimination of paper-based records in favor of digitalized data can increase data integrity and software can guarantee data cannot be modified or deleted and can add 21 CFR Part 11 compliance for traceability.

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