Page 88 - Assurance of Sterility for Sensitive Combination Products and Materials

74 Assurance of sterility for sensitive combination products and materials

manufacturing personnel will require industry to rely more on auto-
mation and continuous process manufacturing as well as less complex
plants. The push toward ATMP will require smaller specialized plants.
This aligns well with shifts in the workforce where young high-tech
talent is being attracted to the area.
• The return on investment is favorable: Many of the most successful
blockbuster health-care products are sterile injectable or implantable
produced by aseptic processing. This is a strong business and financial
driver for improving the productivity and efficiency of aseptic processes.
• It is the right thing to do: The effectiveness of biopharmaceutical therapies,
the demand for these products in emerging growth markets, the cost of
health care, and health-care product shortages all emphasize the need for
product availability and affordability. In addition to this, shareholder pres-
sure to achieve better returns and performance will drive the industry to
seek the best in class manufacturing process efficiency and productivity.
This will create a win-win situation for both industry as well as the patient.
The future of aseptic processing lies in the use of technology to meet
and exceed the requirements of existing products and new therapies. The
time is right to integrate and implement available advanced technologies
and further develop new technology. Aseptic processing would benefit
from the use of automation, virtual and augmented reality, artificial intelli-
gence, machine learning, and predictive modeling. Technological advances
in contamination control using barrier systems, such as isolators and closed
RABS, closed container filling, post-aseptic lethal treatments, lower tem-
perature terminal sterilization, rapid microbiological monitoring and test-
ing, methods can significantly reduce the amount of human interaction.
Higher productivity and reduced risk can be achieved through continuous
process manufacturing, and parametric or real-time release for sterile prod-
ucts. Facilities of the future could be modular with a trend to smaller, less
complex, and easier to control critical product exposure spaces. The further
development and use of new technology to achieve the required level of
aseptic processing improvement can and will result from a partnership of
product manufacturers, technology suppliers, and regulators.

4.30 Conclusion: Quality risk management and risk-based
critical thinking

The aseptic processing of sterile combination products follows the same
requirements and points to consider as the aseptic processing of drug
products. The objective of the aseptic process is to prevent microbiological