Unique Bioprocessing Challenges: Solvent Handling, High Energy, Potent Compounds, and Hazardous Materials

From the Authors - Herman F. Bozenhardt and Erich H. Bozenhardt

We often think of the pharmaceutical and biotechnology business as a world of water and benign proteins. That is true for a significant amount of the products, however most major manufacturing organizations have exposure to steroids, oncology products, cyto-toxic chemicals, potent APIs, solvents, and oxidizing chemicals. These materials are part of our product portfolios as either the drug substance or a critical intermediate in the manufacturing process. These compounds will be with us for decades to come, so it is incumbent upon us to get familiar with them and learn how to handle and process them safely. That is the key message of this e-book: safety for our manufacturing personnel, our environment, and our patients.

In our first e-book about design, we discussed how passionate we are about what we do. Much of that passion is derived from our commitment to designing, constructing, and operating safe, sustainable and environmentally-friendly facilities. 

This e-book shares some of our experiences in the more hazardous areas, and in turn challenges you to look at your facilities and operations to apply some basic safe design philosophies to whatever you are working with, potent or not. We sincerely hope you enjoy them and continue to be safe.

The current e-book covers a few important topics:

• Handling & Processing Of Potent Compounds: A Holistic Approach
• An Introduction To Liposome Processing For Drug Delivery
• Key Engineering & Facility Considerations For Liposome Manufacturing
• Mystery And Danger: Flammables And Oxidizers In Pharmaceutical Filling Operations

“Safety isn’t expensive, it is priceless”