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Advancing a Proven
Aseptic Fill-Finish Process

At the center of ApiJect's design and technical solutions is Blow-Fill-Seal, an industry-recognized advanced aseptic fill-finish process.

About Blow-Fill-Seal

Blow-Fill-Seal (BFS) is a globally-trusted aseptic packaging technology where the pharmaceutical-grade plastic container is made, filled with the drug product, and sealed in a continuous process.

BFS is used around the world to package billions of doses of both large and small molecule sterile drug products annually, including vaccines.

Advantages of BFS

The rotary BFS machines made by Rommelag® that ApiJect primarily uses have several potential advantages over more traditional fill and finish processes, including:

  • Very efficient with almost no human intervention
  • Compact resilient supply chain
  • Scalable manufacturing for development and commercial
  • Aseptic filling in a closed ISO-5 environment
  • Single primary raw material: pharmaceutical-grade polymer resin
  • No glass particulates or shards
  • Lightweight and resistant to breakage
  • Cost-effective unit-dose filling
  • Highly-customizable container shapes and volumes

Taking BFS Further

At ApiJect, we are expanding BFS so that it can be the primary container that delivers a wide range of parenteral medicines and vaccines. This will allow more pharmaceutical and biotech companies to consider using BFS as a suitable aseptic filling process for their liquid drug products.

For example, at the new ApiJect Technology Development Center in the greater Orlando, FL area, our engineers re making advances in better controlling the temperature of the drug product throughout the BFS process. Likewise, we are developing various BFS mold sizes and configurations, with manufacturing testing in both a small-scale Weiler® Lab+ shuttle BFS machine as well as a Rommelag® Bottelpack 434 rotary BFS machine.

In addition, our engineers are developing and testing various needle hubs and other components that can be attached directly to the BFS container, enabling inline delivery of the drug product without transfer to a syringe or other external delivery system.

Learn more about how ApiJect works with pharma,
biotech companies, and contract manufacturers

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