Discover how Ritedose leads the industry in delivering safe, scalable, and contamination-free drug products through advanced BFS innovation.
Blow-Fill-Seal is taking the pharmaceutical world by storm. Here’s why Ritedose specializes in it.
The most important part of manufacturing medicines is product safety. Microbial or chemical contamination is a major challenge to maintaining that safety. At Ritedose, ensuring the purity and safety of every drug product starts with advanced pharmaceutical manufacturing—specifically our Blow-Fill-Seal (BFS) technology.
Future Outlook: BFS in a Growing Market
Ritedose is one of the world’s largest CDMO (contract development and manufacturing organization) that uses Blow-Fill-Seal (BFS) technology. According to a recent report, it’s estimated that the current worldwide market value for BFS is $3.10 billion as of 2024 and is expected to more than double to $7.2 billion by 2032. While pharmaceuticals account for about half that market value, the food industry and other manufacturing sectors are also looking to BFS. In the same report, Ritedose ranks 15th in the world for volume of BFS manufacturing (this list includes food and beverage, and personal care products as well as pharmaceuticals).
Overview of the BFS Process
Blow-Fill-Seal has been used to achieve aseptic fill and finish of small molecules as well as biological liquid formulations. These include nebulized respiratory treatments and multiple ophthalmic solutions. It is a completely closed system—the plastic container is formed, filled with sterile drug products and then closed and sealed, while minimizing any human interaction.
How does Blow-Fill-Seal work?
True to its name, BFS works in three major steps:
- Blow: plastic (usually polyethylene) is melted and flows to form a parison. Then, sterile air or nitrogen gas blows or inflates the parison into a mold. The plastic takes the shape of the mold.
- Fill: while still in the molding position, the plastic container is filled with liquid drug product.
- Seal: once filled, the container is sealed to maintain sterility and purity of the product.
All of this happens within seconds. Millions of unit doses can be created by BFS in the space of a day, depending on the number of BFS machines a manufacturer has operating. Since nearly all of this process is automated, and conducted in a sterile facility, the BFS process greatly reduces the risk of contamination or even human error seen in traditional manufacturing “fill and finish” methods. And, because all three steps are integrated as a single operation, production time and labor costs are minimized while productivity is enhanced.
BFS can also open the door to efficient production at higher volumes, scaling up production to meet increased demand and decreasing dependence on external sources, thus simplifying the supply chain.
What material does BFS use?
Another key advantage of BFS is the move away from traditional glass ampules for unit-dose drugs. Glass is heavier, bulkier and can break more easily. All BFS processes, including those at Ritedose, utilize plastic polymer raw materials. These include low-density polyethylene (LDPE), high-density polyethylene (HDPE) and polypropylene. LDPE is popular because it can be formed at a lower melting temperature than other plastics, provides a more flexible container, and allows for adequate protection of the product.
Some drug products (particularly large-molecule biologicals) can form chemical interactions with the plastic containers, so labs must perform analytical stability tests to make sure these interactions (absorption, adsorption, structural alterations) don’t diminish therapeutic effectiveness. These tests should also address other excipients in the drug solution, to ensure other ingredients besides the active pharmaceutical ingredient (API) have no adverse impact on product effectiveness.
Types of BFS Machinery
There are two types of BFS machines—shuttle and rotary. Ritedose only uses closed parisons machines, relying heavily on rotary BFS equipment.
Shuttles were the first type of BFS machines. With this technology, the container-creation step takes place in a different place from the filling and sealing steps. Shuttle machines are slower than rotary machines and have lower output. But they can be adapted quickly to new manufacturing requirements.
Rotary machines make the blow, fill and seal steps all in the same location, in a closed system. Rotary machines have faster cycle times (3-8 seconds) and are more amenable to scaling up to larger volumes.
Closed System for Contamination Prevention
It’s important to note that BFS is part of a larger filling process that avoids contamination. This process starts with a capacity to fill many volumes of solutions, suspensions and emulsions, from 0.2 ml to 15 ml. State of the art BFS machines (rotary and hybrid filling machines) using standardized container molds protect the product while reducing manufacturing costs.
Our facilities can handle billions of units every year, using ISO 7 cleanrooms and ISO 5 classified filling space, managed by a team of dedicated filling employees.
Historical Adoption and Industry Use Cases
The first blow-fill-seal machine was invented in 1962 by Gerhard Hansen, the founder of Rommelag, a CDMO and BFS manufacturer in what was then West Germany. Hansen, an engineer, had been working with plastic film extrusions for at least 10 years before developing a BFS prototype.
BFS was originally envisioned as a new way to package and deliver sterile liquids. It has since expanded to a wide range of medicines, including ophthalmic medicines, respiratory therapies, and injectables. It also has moved into aspects of the food industry and other fields that require sterile conditions.
The first BFS machines have evolved dramatically since the first shuttle varieties were used, improving output, efficiency, and enhancing aseptic processing in manufacturing medicines.
A Vision of BFS’ Future
The future of aseptic drug manufacturing is clear: Blow-Fill-Seal technology delivers unmatched sterility, scalability, and cost efficiency. Regulatory pressures, chronic disease trends, and the push for more sustainable, high-volume solutions all reinforce its value. As the largest U.S.-based CDMO specializing in BFS for ophthalmic and respiratory drugs, Ritedose continues to expand capacity and capabilities.
Patients and providers alike rely on BFS for safer, more consistent drug delivery. With tens of billions of doses produced without a single interruption, Ritedose continues to lead the way in sterile BFS innovation.
Ready to scale smarter? Let’s talk.
About The Ritedose Corporation
Ritedose is the largest sterile contract development manufacturing organization (CDMO) in the US specializing in sterile Blow Fill Seal (BFS) technology that ensures sterile, consistent, and safe unit dose delivery. The company’s process guides the development of molecules from clinical trials to commercialization of branded and generic inhalation and ophthalmic medications. With a focus on quality, innovation, and customer satisfaction, Ritedose partners with leading pharmaceutical companies to deliver safe, effective, and reliable medications that improve patient outcomes. Ritedose: Passion and Precision with a Purpose. For more information visit Ritedose.com
