Clean Facility Roundtable Part 5: The Future of Sterile Product Processing

Clean Facility Roundtable Part 5: The Future of Sterile Product Processing

Monday, March 11, 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 fifth roundtable discussion, key stakeholders were asked:

In the near future do you see pharmaceutical companies moving away from large cleanrooms to processing sterile products in isolators, gloveboxes or RABS? If so, why?

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. Next up, our third roundtable features a discussion on whether pharmaceutical companies are likely to implement the same strict mircobial monitoring strategies used for sterile products on other types of products and finally our fourth roundtable discusses recommended practices a pharmaceutical company should put in place to collect, store, and analyze microbial monitoring data.

Claire Briglia
Technology Specialist, MilliporeSigma
Claire Briglia

FDA has stated several times that all new aseptic processing lines should be in an isolator or RABS. If you construct a conventional clean room instead, your facility will be scrutinized on every inspection.

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

Yes, in an effort to reduce the risk of human contamination the introduction of robotic manufacture in RABS or other isolation systems will become more common. Many companies are already investigating the options in this field and as the these become commercially available companies will transition their processes to these kind of manufacturing environments.

Poonam Bhende
Assistant Manager, SGS Life Science
Poonam Bhende

We are not seeing a huge shift right now. There are certainly situations where clients have specific requests for isolators. However, there are situations where that’s not appropriate or possible, for example with medical devices – the samples are large and wouldn’t fit in an isolator, and must be tested in a cleanroom environment.

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

An increasing number of manufacturers are producing personalized medicines whose batch size is inherently smaller than classical drug production. 

Since many of these drugs have short shelf lives and are often administered before final sterility test results are available, it is critical to reduce risk as much as possible. 

Automated testing that can be easily performed near the manufacturing area can bring faster time to result and enhance the compliance, productivity and safety of the production facility and the drugs they produce.