An Overview of Aseptic FillFinish

Aseptic fillfinish first hit the market in the 1920s. For a drug, this can be considered relatively recent, and it was created out of the need to meet the needs of injectables and large scale manufacturing of blood and plasma during WWII. 

The world needed certain drugs that couldn't undergo the rigors of the previously used filtration processes. Plasma, for example, did and still has significant use in the hospital, and previously had to undergo a post-fill filtration of low heat treatment. 

This pasteurization process wasn’t effective as it didn’t sterilize the plasma but only reduced the chances of getting contaminated by fungi. Back then, anti-fungal reagents may also have been added to parental drugs to reduces their chances of contamination. 

The world saw her first glimpse of what we now called aseptic fill-finish in 1981. That was when the Parental Drug Association published its Aseptic Validation Technical to improve the consistency in aseptic processing. Then followed the FDA Aseptic fill/filling process in 1987 and then the most updated version of this guideline published in 2003. 

Regulatory Considerations 

A larger majority of drugs that use aseptic fill finish are inhaled, injected, or consumed in any other manner that bypasses most of the body's natural defenses. To guarantee the safety of patients, the FDA has set up rules that guide aseptic fill manufacturers on how to go about the process. For aseptic filling to be successful, the product, facilities and equipment, components, and staff must all be working together. 

Each country has its own unique set of rules regulating the manufacturing and use of aseptic. In aseptic processing, drugs, their containers, and closures are subjected to separate sterilization. Only after each element is sterilized that they are put filled and closed together in a sterile and high-quality environment. Another one of FDA's rules on  Aseptic rules states that:  

“for each batch of drug product purpoting to be sterile and/or pyrogen free, there shall be appropriate testing to prove its confermance to such requirement. The test procedures will also be written and followed.”

Factors That Influence the Success of Aseptic Fill Finish

•The facilities (a clean environment): the room in which sterilization as well the filling of drugs is done must be sterile. As with the other parts of aseptic fill, each process is a complicated one. For a clean room, manufacturers must ensure they combine sealed off physical rooms and high-efficiency particulate Air to create unidirectional airflow. This also helps maintain the proper air pressure while keeping the room sanitized.

•Type of sterilization used: there are five primary ways to conduct an aseptic fillfinish, and they are:

-Ethylene Oxide Gass Sterilization

-Heat sterilization:

-Radiation sterilization:

-Filter sterilization

-Drug products component

•Component preparation: there are many ways to fill sterile drugs aseptically. Traditionally, you will find methods such as filling glass vials and syringes, sterile powder fills, blow-fill-seal, and sterile lyophilization.

Aseptic sterilization has helped humanity deliver medication to the specific areas where they are needed, but in doing so, we risk contamination. This is where aseptic fill finish comes in to ensure whatever medical product we consume is sanitized.