Blow-Fill-Seal Technology Continues to Grow Heading Into 2023

Dr. Kuljit Bhatia headshot

Woodstock Sterile Solutions (WSS) started operating as a stand-alone business in 2021, but we are entering our 55th year in business, as we trace our roots back to 1968 when we were foundedToday, we are a global provider of best-in-class sterile development and manufacturing solutions across a broad – and growing range – of applications. Since the beginning, we have been considered a leader in developing and deploying advanced aseptic blow-fill-seal delivery products for healthcare.

What is blow-fill-seal, or BFS packaging? It is an automated process that forms a plastic container, fills it with product and seals it in less than 15 seconds. These steps are all completed under aseptic conditions without human intervention, ensuring sterility and making it an ideal solution for the packaging of ophthalmic, respiratory and otic dosage forms. But the benefits of BFS are not limited to reducing the likelihood of contamination.

Using the BFS process allows for single unit dosing. In a single-dose container, the BFS process fills the exact amount needed, and since it can be easily carried, patients can take the medicine anywhere, anytime, helping them to comply with their prescription. Compared to glass vial manufacturing, there are fewer components in plastic single-dose packaging. This means that there are no stoppers to deal with, crimp tops or other closures. Since the plastic is sterilized during process, there are no equivalent cleaning steps to the ones needed for glass vials. There are also no equivalent treatment steps to the ones that glass vials go through, such as depyrogenation. At WSS we have the capability to develop and manufacture light, oxygen, temperature and pH-sensitive products. In addition, we can handle potent and highly potent compounds. 

Finally, with the streamlined packaging structure used in BFS, production is easy to scale. At Woodstock Sterile Solutions, we partner with our customers early in the development process, producing small batch sizes from as little as five to ten liters. We work with them to finalize their formulation/process and ensure a robust process scale-up for full-scale production. With BFS you can produce millions of these packages in just a few days. At Woodstock Sterile Solutions, we perform leak tests on each unit that we produce to ensure that the highest quality standards are being met.

The benefits outlined above make BFS packaging a popular option for the ophthalmic and respiratory markets for small molecule formulation, but the technology is also making inroads with companies that produce biologics and large molecules.

In the past, organizations were concerned that the plastic used in BFS would negatively affect biologics and large molecules. This concern has been disappearing, after many years of R&D comparing glass versus plastic have shown similar results in terms of compatibility for small and large molecules. Manufacturers were also worried about the impact of heat generated during the BFS process. Certain biologics have poor stability, and significant efforts are dedicated during development to improve shelf life of proteins, peptides and biologics, so introducing high levels of heat for an extended period can impact their shelf life even further. At WSS, we have investigated and developed several parameters across the manufacturing process to reduce the impact of temperature on product in BFS. Specifically, we have optimized parameters such as bulk temperature and transfer to BFS machine, fill volume and vial mass relationship, and other BFS machine parameters. This has resulted in significantly reducing or eliminating temperature impact on thermally sensitive molecules. As those in the biologics industry begin to realize this and read information and articles that confirm the compatibility of BFS with biologics, they are starting to come around and use the technology more frequently.

What’s Next for BFS?

The next step in BFS is determining how best to use the process with devices – whether that is with an injectable, a dropper or other dispenser. There are inherent challenges that need to be addressed. For example, inconsistent delivery and backflow. There are also a number of regulatory hurdles that need to be overcome. Right now, there are a lot of ideas swirling around, and in the coming years, we will see the industry work toward developing BFS device/drug combination products.

At Woodstock Sterile Solutions, we are also working to do more with diagnostic applications, including diagnostic agents. We will be seeing more of that in 2023.

If you are interested in finding out more about Blow-Fill-Seal packaging and how we can work with you from development to full-scale production, contact us today.

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