Benefits from a Better Understanding of Aseptic Processing
Aseptic processes are some of the most difficult processes to conduct in the pharmaceutical industry. Managing the high cost and sensitive nature of aseptic processes requires constant attention and maintenance. Due to their criticality to patient safety, injectable drugs receive intense scrutiny from FDA and other agencies. Quality concerns create heightened demand for innovative solutions to reduce or avoid non-conformance. Regulatory pressures call for vigilance when implementing best practices and innovation in design, build, qualification, and operation of aseptic facilities.
As a program committee member for the 2018 ISPE Aseptic Conference, I can tell you that there are many advantages to continued education to expand your knowledge and continue the conversation on this evolving field.
Here are just a few learning objectives you can expect to take away from the event:
Learn how to manage the complexities of a high potent fill-finish process effectively
Identify relevant issues for single-use system implementation
Explore implementation of the newest technology in aseptic filling
Determine how to eliminate risks of contamination transfer through barrier technology management
Examine the strong industry trend toward smaller-scale Combo/Flexible fillers using ready-to-use (RTU) components e.g. vials and syringes
Review how multi product-family facilities are being licensed to maximize value through more efficient deployment of capital assets
Standout sessions include:
Evolution of Robotics in Aseptic Technology
A panel of machine manufacturing companies will share the advantages and disadvantages of using robotics in aseptic processing and how it contributes to product safety. It’s been two years since we brought back this popular industry panel session, so I’m looking forward to seeing if that future has become a reality and learning about new applications on the horizon.
Hear directly from regulators about your most pressing concerns in aseptic processing and interact with FDA panelists as they answer audience questions and share their thoughts on the industry. This staple session is one of my favorites as it facilities open dialogue between manufacturers, suppliers, and regulators.
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