Aseptic Systems Design: Looking To The Future

The world of aseptic systems has evolved faster in the last 5-10 years than it has over the history of the industry. The main driving forces of these changes are:

• Wide and diverse volume of new therapies that must be dispensed aseptically
• Tightening of regulatory requirements through awareness and necessity
• The widespread use and acceptance of single use systems
• Development of robotics and automation
• The experience and evolution of sterilization methods

All these drivers have been accelerated by computing technology.

Designing, engineering and building the newest aseptic facilities or renovating a facility today involves the application of the most transformative technologies. Our decisions today are driven by the EU Annex 1 globally, using technologies to “close” and encapsulate the entire process in a supportive atmosphere. We build the facilities smaller and drive to eliminate the human interaction and intervention and ultimately achieve the most efficient process. We as implementers of this technology can make the difference in drug delivery by reducing the time to market by months and sometime years to patients desperately waiting.

Designing these production systems and facilities and assuring these technologies perform is our daily challenge.

Below is a collection of our articles that cover the major aspects of our engineering concepts, successes and failures. The success and failures are equally important as lessons in our evolution and journey in achievement in this business. We hope you enjoy!

This e-book is our fourth collective effort and is a collection of nearly 60 years of experiences and being witnesses to and practitioners in this most critical care aspect of the pharmaceutical business.