SFF
The ideal time to select the appropriate fill form is not during Phase III, but rather in the initial stages of development. Early consideration and agreement on the fill form are crucial to ensuring a smooth transition from development to clinical trials and commercialization.
Exploring alternative container formats like BFS offers developers several advantages in meeting the increasing demand for sterile manufacturing:
- Low Contamination Risk: BFS containers are formed, filled, and hermetically sealed in a sterile, enclosed environment within the BFS line, eliminating human intervention and minimizing the risk of contamination.
- Flexible Filling Options: BFS containers can be tailored to meet product-specific needs and accommodate single or multiple doses. Unidose formats can eliminate the need for preservatives, enhance dose accuracy, and reduce product waste.
- Reduced Breakage Risk: Unlike glass, plastic BFS containers have a lower risk of breakage, reducing the need for secondary packaging and lowering storage and transportation costs.
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Streamlined Process: A glass filling line requires multiple components, such as caps, vials, and stoppers, which must be stored, washed, dried, sterilized, and stored again before filling. BFS technology simplifies this process, making it faster and more efficient. Supply Chain Security: While glass vials and their components have faced supply chain challenges, BFS relies on readily available polymers, such as low-density polyethylene (LDPE), reducing the risk of supply chain disruptions.
How the BFS Process Works
Blow-Fill-Seal (BFS) technology creates containers from thermoplastic granules, fills them with the product, and seals them—all in one continuous, automated operation. This process takes place in a sterile, enclosed environment, completely free from human intervention. The product pathway eliminates the need for aseptic connections during bulk transfer. From cleaning to sterilization, the entire process is fully automated, with machines ready for pre-use integrity testing after sterilization
Utilising BFS in Early Development: Introducing the LAB+ Machine
The innovative LAB+ machine is designed to support early lifecycle development with BFS technology. It is rapid, flexible, and highly safe for sterile filling, making it ideal for early development projects such as proof of concept, small-scale clinical batches, small commercial production runs, and early stability studies.
The LAB+ machine, the first of its kind in the European Union, is highly versatile, capable of produce various dose designs and it supports a range of container polymer types such as LDPE and polypropylene. The state-of-the-art equipment is particularly suited for sensitive compounds and very small batch sizes. The machine can manage batch sizes ranging from 200 mL to 20L and can fill solutions, gels, suspensions, and emulsion drug products, including ophthalmics, inhalation treatments, and sterile injectables.
The LAB+ machine is also capable of producing vials with a luer lock neck, which is compatible with a range of delivery devices, significantly enhances the machine's versatility. Operating within a sterile fill-finish environment, the LAB+ machine also offers additional capabilities such as nitrogen filling for biological products and maintaining a temperature-controlled environment.
In summary, by incorporating BFS during the development phase, you can avoid surprises later in the manufacturing process, as your product can be tested under the exact conditions of a commercial BFS machine. This approach allows for adjustments and parameter testing, ensuring that the final product meets all necessary requirements.
Learn more about our LAB+ BFS machine.
In recent years, a variety of alternative container formats have emerged alongside the traditional vial. Each of these formats has unique features and benefits, making them more suitable for specific applications, especially when patient centricity is a priority. Early consideration of the formulation's unique needs and careful planning of the final manufacturing process are essential to selecting the right container. Partnering with an expert contract development and manufacturing organization (CDMO) ensures that the chosen container and manufacturing method are well-suited to the formulation.
With expertise across a wide range of formulation types and applications—including ophthalmics and vaccines—along with materials compatibility testing and process development capabilities, we are ready to guide your BFS project from development through clinical stages to commercialisation.