Clean Facility Roundtable Part 3: Applications for Strict Microbial Monitoring

Clean Facility Roundtable Part 3: Applications for Strict Microbial Monitoring

Friday, January 18, 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 third roundtable discussion, key stakeholders were asked:

Do you foresee pharmaceutical companies implementing the strict microbial monitoring strategies used for sterile product production on other types of products – such as solid dosage?

Check back to our first roundtable to read about must-have technologies for meeting microbial monitoring requirements while staying within regulatory guidelines and our second roundtable for a discussion on what some relatively easy, first steps a pharmaceutical company can take to upgrade its microbial monitoring.

Claire Briglia
Technology Specialist, MilliporeSigma
Claire Briglia

Non-sterile products that contain a high percentage of water pose a significant risk of gram-negative bacterial contamination; thus, this will continue to be a regulatory focus and will require strict microbial monitoring.

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

Yes, we do see the FDA suggesting more routine environmental monitoring for all types of manufacturing. Frequent environmental testing and monitoring is an important tool for demonstrating that a facility is in control.

Poonam Bhende
Assistant Manager, SGS Life Science
Poonam Bhende

We are seeing some clients in non-sterile environments stepping up their microbial monitoring strategies. Specifically, clients concerned about B. cepacia. They are adding HEPA curtains around their non-sterile rooms, either as a preventative measure or in response to FDA findings.

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

Data Integrity will always be important regardless if the production is for sterile or non-sterile products because accuracy of data can impact drug safety. Hence, reducing all human-related sources of error should be optimized independent from the facility type.

Identification of “objectionable microorganisms” is another topic that continues to be of importance for all drug types; including combination products such as nose sprays.

Consequently, the EM process including actions to improve data integrity, ensure the performance of culture media and any other action to optimize of the EM process should be no less importance than in sterile production sites.

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