The Basics of Aseptic Filling

Aseptic filling of sterile drugs is among the most critical processes in biopharmaceutical manufacturing. A patient whose health is already compromised by an illness or injury simply cannot afford to receive tainted medication that could result in a delayed recovery, or even death. Therefore, pharmaceutical manufacturers must act with care to select well designed aseptic filling equipment that prevents cross contamination and ensures a clean, measured fill.

What is Aseptic Processing?

Aseptic processing involves the packaging of a sterile product in a manner to ensure its sterility. Found primarily in the food and pharmaceutical industries, aseptic processing is used on a regular basis to ensure purity and extend shelf life. Containers commonly used in the pharmaceutical industry are sterilized bags. As a component of this process, aseptic filling is the step when the material is placed into the sterile container and sealed.

History of Aseptic Processing

The history of aseptic processing is relatively new and took a big leap forward during the 1940s. Originally, sterility requirements for injectables were established in the 1920s, but requirements understandably grew with WWII. Larger scale biological manufacturing of blood and plasma products required advances in aseptic processing, which resulted in the use of an aseptic fill pasteurization process. This required a low heat treatment of 60°C for 10 hours and while this pasteurization process did not provide sterility, it reduced the contamination of fungi. Anti-fungicidal reagents were also added to parenteral drugs to help mitigate the contamination that was occurring with early aseptic processing.

How is Aseptic Filling Achieved?

Aseptic filling is a process that requires the close coordination and complex interaction between personnel, sterilized product, the fill/finish equipment system, cleanroom and support facilities, and sterilized filling components. Generally, the most important component of any aseptic filling operation is the prevention of contamination by staff. Since there are only indirect safeguards for the sterility of the filled drug after it is stoppered and capped in the cleanroom. Unlike terminal sterilized filled drugs, the stability of the aseptic filled drugs will be affected by steam autoclave, dry heat ovens, Ethylene Oxide, and irradiation, either Cobalt 60 Gamma or E Beam. Thus the need to use a careful, methodical aseptic process to fill certain biologicals, pharmaceuticals and biotechnology drugs is necessary.

Keys to Selecting the Right Equipment

Selecting the right equipment can be easily accomplished for medical and pharmaceutical manufacturers by simply remembering several key suggestions. First, equipment should be selected that minimizes the contamination risk by reducing contact with staff. Second, reduce the necessity for cleaning equipment by considering the use of single use components. Finally, select equipment that is easy to use and that can accommodate a wide variety of container sizes and capacities.

In conclusion, the aseptic filling process is among the most important in biopharmaceutical manufacturing. With a strong understanding of aseptic processing, methodical aseptic filling procedure and the selection of appropriate equipment, pharmaceutical manufacturers can ensure the safety of patients while growing their businesses using a safe, reliable the can be depended upon to consistently deliver results.


------

About ASIFill.com Operated by Advanced Scientifics, ASIFill.com offers an advanced aseptic filling fixture that provides a simple and secure method of filling single use bags in a sterile, closed format. For more information please visit: www.asifill.com