Media Fills: Literally Cleaner than Clean

Aseptic processing is manufacturing that is free from contamination. This technique is essential in ensuring that sterile, liquid-fill pharmaceutical products remain bacteria free and safe for patient use. In order to test if a facility has good aseptic technique, plants must routinely perform testing, referred to as media fills. A media fill is an aseptic manufacturing simulation that uses a sterile microbiological growth medium (a solution free of microscopic organisms but that can support growth of these organisms) in place of the active drug solution. Read on below to learn more about the various types of manufacturing environments and how media fills fit in!

Aseptic manufacturing is a process in which every component (operators included) of every unit operation is sterile or critically controlled. A media fill is a method used to simulate the process and demonstrate whether it produces sterile drug products and to “qualify” process personnel, as operators aren’t certified until they participate in a successful simulation. There is zero tolerance when it comes to failure of a simulation (not even one unit operation can exhibit microbial growth). Worst-case scenarios (in compounding and filling) such as older equipment and extra operators, are employed when running a media fill, to stress the system to provide the greatest level of challenge.

Deciding what type of aseptic manufacturing process can be used on a specific product involves significant considerations. Some are listed here:

• Can the product be sterilized by moist/dry heat conditions?
• Can the product be sterilized with a combination of moist/dry heat & time?
• Can the product be sterilized using a radiation method?
• Can the product be sterilized by filtering it through a microbial retentive filter?

At AbbVie, aseptic processes, specifically fill operations, are used in all the biologic, toxin & some ophthalmic product finishing operations. Finishing refers to the processes where the drug product is added to its respective container and enclosure (i.e., syringe, pen, vial, etc.).