The aseptic filling process refers to packaging commercially sterile products into containers and preserving them with a hermetic seal. The process is necessary to protect certain drugs and keep them sterile. It's a critical process because the recipient is usually immunocompromised.
Aseptic filling has become more regulated since its beginnings in the 1920s. Innovations in sterilization and storage have streamlined the process. Researchers are always looking into new ways to improve aseptic filling for cartridges.
Sometimes, the terms sterile and aseptic are confused. Although they are both processes to remove harmful microorganisms from a substance, the way they happen differs.
An aseptic drug has had all harmful microorganisms, bacteria, and viruses removed. After the process, the drug will not produce more germs or bacteria, making it "contamination-free".¹ Sterilization means the complete removal of all extraneous bacteria and germs. This process doesn't differentiate between harmful and harmless.
Generally, drugs require an aseptic process. Sterilization destroys the whole product, while aseptic processing can isolate the required germ or virus. The aseptic technique also keeps the bacteria in question from reproducing, which could cause dosage issues.
Sterilization is a critical process for specific procedures, like surgeries. However, when storing drugs or food, an aseptic process is often preferred.
The aseptic process is more complicated and regulated than the sterilization process. Unlike sterilization, which is more like a blunt tool, creating aseptic conditions requires careful, exact procedures.
The process of aseptic filling began to take form in the 1920s but became necessary during WWI and II. As medicine advanced, it became clear that sterilization of vials, syringes, and needles was critical to prevent infection. Field medics used Bunsen burners to sterilize tools, but the transfer of materials from cartridge to vial was often susceptible to contamination.
In the 1930s, pharmaceutical manufacturers began using membrane filters to stop vials, reducing the contamination rate.²
During WWII, manufacturers produced plasma and blood for transport. Instead of using sterilized vials, they used a pasteurization process after filling, which reduced the fungi rate.
After WWII, the pharmaceutical industry continued to research how best to maintain clean, sterile environments to produce injectable products. The use of HEPA Filters became widespread. It became clear that products containing a virus could not undergo sterilization.
However, it wasn't until the 1970s and ‘80s that governments worldwide developed regulations for the industry. The FDA published its Guidance for Industry in 1987 and regularly updates it to reflect breakthroughs.
Today, pharmaceutical manufacturers must abide by strict governmental regulations when filling aseptic cartridges. At BioStem Life Sciences, you receive a final packaged product that is ready to use. All fill process documentation and final product testing data are available for your inspection.
The aseptic fill-finish process occurs in the state-of-the-art aseptic filling suite. Exit and entry gowning, crimping and dispensing of product into vials, and labeling and inspection of finalized vials happen in two designated rooms. In addition, BioStem Life Sciences has semi-automated machines for dispensing bulk liquid.
The industry is always looking forward to the next innovation. Several challenges make aseptic filling problematic and new research into increasing product volume is reducing production time and helping fill cartridges to a higher standard (requiring less contamination).³
BioStem Life Sciences is always pushing toward innovations. To learn more about our products, processes, systems, or filling machines, browse our website. Talk with our expert team to learn more about increasing drug development times by using a trusted and tested cartridge filling process.
(1) Choudhary, Ankur. "Difference Between Aseptic and Sterile Conditions." Pharmaceutical Guidelines, October 2018, Retrieved September 17, 2020, from https://www.pharmaguideline.com/2017/10/difference-between-aseptic-and-sterile-area.html.
(2) Frantz-Sanofi, Joseph C. (n.d.). "Aseptic Processing Overview." A3P, Retrieved September 17, 2020, from https://www.a3p.org/aseptic-processing-overview/.
(3) "Re-thinking Aseptic Filling – Innovations for Pharma's Challenging Requirements." XTalks, January 28, 2020, Retrieved September 17, 2020, from https://xtalks.com/webinars/re-thinking-aseptic-filling/.
If you have questions about the company, our lab, our scientific team or anything else, please feel free to contact us.Contact Us