Avoiding Contamination Risks in Aseptic Processes - Pharmaceutical Technology

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PharmTech Europe

Avoiding Contamination Risks in Aseptic Processes

Pharmaceutical Technology Europe
Volume 23, Issue 12

Barriers to new technology uptake

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The largest barrier hindering the uptake of new aseptic technologies is the pharma industry’s reluctance to use a technology that has not been approved yet. There is always a small risk that a complete drug development application using new technology will be rejected by regulators. However, this risk is minimised if both the vendor and the pharmaceutical company together build a solid scientific rationale, including robust risk analysis, to support the use of new technology. Authorities are also open to informal presentations of new technologies and, in my experience, are much more open to new technologies than many believe. It would be useful if authorities provide official advice and opinions on new technologies regarding their potential acceptability and benefit to the patient. This could significantly accelerate the development of new technologies and provide faster benefits to patients.

The future

In the coming years, I believe that the authorities will reject more aseptic solutions which do not minimise contamination risk. Five years from now, equipment in a clean room setting may face difficulties to be approved for aseptic filling as a robust risk analysis would point out the risk of contamination due to the vicinity of the operator and the filling area . Instead, use of barrier systems and disposable technologies will continue to grow; several companies now offer fully disposable solutions for biological drugs that can be used throughout fermentation, purification, formulation and during the filling process.

Containers will also evolve; several companies have already begun to replace glass with more robust materials, such as polymers. As a result, there will be a decreased risk of small cracks, which are a significant source of contamination. Furthermore, big problems, such as the recently discovered issue of delamination with several drugs such as Erythropoietin and methotrexate, may be avoided.

Benoît Verjans is chief commercial officer of Aseptic Technologies. http://www.aseptictech.com


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