Blow-Fill-Seal BFS technology

Rommelag Engineering is a world leader in BFS Blow-Fill-Seal technology, the technique of producing, filling and sealing plastic containers in a fast and continuous process.

The Rommelag Bottelpack® process for combined manufacture and aseptic fill of BFS vials and bottles is ideal for pharmaceutical fill and finish operations, using newly formed and sterile plastic containers.

Blow-Fill-Seal (BFS) technology

The BFS manufacturing technique can be used to produce containers with filling volumes as small as 0.1mL, ranging up to 500mL or more.

Blow-Fill-Seal technology was invented in 1962 by Rommelag’s founder, Gerhard Hansen, taking advantage of recent advances in plastic technology, particularly using polyethylene and polypropylene.

The basic BFS concept involves forming plastic container from polymer resin granules inside a blow-fill-seal machine that also fills the newly made container and seals it in a single autonomous and advanced aseptic process.

The technology has increasingly been adopted in pharmaceutical packaging for its inherent efficiency and aseptic advantages, with various regulatory organizations including the U.S. Food and Drug Administration (FDA) which has now characterized BFS as an “advanced aseptic process”, indicating its use as a preferred technology for aseptic packing of liquids and semi-solids.

The basic BFS process has five principal stages.

1. 1. A medical-grade plastic resin is molten in an extruder and extruded through a nozzle and blown with sterile air to form a tube called parison
   2. This parison or cut parts thereof are then blow molded into the container-shape within a two-part mold
   3. Thereafter the containers are filled with the formulation. Finally, the filling mandrels are retracted and a secondary top mold seals the container

All actions take place inside a sterile shrouded chamber inside the machine. The product is then discharged to a non-sterile area for labeling, packaging and distribution.

BFS advantages

As a leading blow-fill-seal manufacturer, Rommelag’s offers innovative BFS technologies and bottelpack® systems that have created a range of unique options for making daily production output more simple, reliable, and cost-effective.

These include:

• Unbreakable user-friendly containers
• A very wide range of container shapes and sizes
• Straightforward adaptation to specific applications and administration regimes
• A superior choice for highly sensitive formulations
• ISO Class 5 safety conditions
• Approved by EMA, FDA and other regulatory agencies.
• Recognized as an advanced aseptic process under US Pharmacopoeia guidelines
• Fully automated processes for manufacturing, filling, and sealing containers in seconds
• Significantly smaller spatial requirements than conventional filling systems
• Exceptional process and product reliability

The BFS process also allows construction of shorter and more reliable production and logistics chains, with no requirement for separate sourcing, delivery and handling of glass containers. In contrast, BFS only requires supply of polymer granulate that is less labor and space intensive. The greater robustness of plastic containers also eases handling requirements in the subsequent logistics chain.