Blow-Fill-Seal BFS technology

Brevetti Angela are world-leading exponents in the technology of Blow-Fill-Seal (BFS) aseptic packaging that can form, fill and seal plastic containers, now including syringes, within a single machine process.

The Brevetti Angela SYFPAC® process for combined manufacture and aseptic fill of BFS large and small bottles, vials, and ampoules is ideal for pharmaceutical aseptic filling and finishing operations, using purpose formed plastic containers.

Blow-Fill-Seal (BFS) technology

The SYFPAC® BFS manufacturing technique can be used to produce small and large volume parenteral liquid containers up to 1L in capacity.

Blow-Fill-Seal technology was originally developed in Europe in the 1930s, taking advantage of post-WW1 advances in plastics, particularly in polyethylene and polypropylene.

The basic BFS concept involves forming plastic containers from resin granules inside a blow fill seal machine that also fills the newly made container and seals it a single autonomous and continuous process. Since all steps take place inside one single machine under a shower of grade A sterile air, the whole process can be regarded as aseptic.

Since the early 1970s, BFS technology has increasingly been adopted in pharmaceutical packaging for its inherent efficiencies and aseptic advantages for packing of liquids.

The BFS process has five principal stages that are all contained within an isolated chamber:

1. Granules of the chosen plastic are heated to a molten form that is then extruded into a hot hollow soft plastic pipe called a parison.
2. The specifically shaped mold fitted to the machine closes over the parison, with pressurized sterile gas fed in to blow the parison against the inner mold face to form the container to desired final shape. The gas used can be air, nitrogen or any other inert gas. The shaping process is assisted by creating a vacuum within the mold cavity.
3. The BFS machine inserts nozzles into the top of the formed plastic container to fill it with product. During this step, the nozzles and the open end of the containers are showered with sterile filtered gas to protect against contamination, continuously monitored by a viable and non viable particle counter.
4. After filling, jaws at the top of the mold close to hermetically seal the filled container.
5. Deflash: The final step is to remove the flash left by the mold halves and deliver the finished container outside the machine, with a cycle time that normally amounts to 10 to 15 seconds.

Once sealed, it is safe to discharge formed containers to a non-sterile area for labeling, packaging and distribution.

Polypropylene, with its superior thermostability, is usually preferred to form pharmaceutical containers, that can be further sterilized by autoclaving. Polyethylene can also be used for softer or more transparent vials, ampoules or containers.

BFS advantages

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

These include the generic BFS advantages of:

• An almost infinite range of container shapes and sizes individually tailored to need
• Contamination-free with no human interaction
• Free of particulates
• Fully automated and cost-effective manufacturing
• Greater ease in matching product to ideal primary packaging format
• Integrated aseptic filling
• Longer product shelf life
• Easier logistics in supply, transport and storage
• Highly scalable production, from niche batches to large volume manufacturing
• ISO Class 5 safety conditions
• Approved by EMA, FDA and other regulatory agencies
• US Pharmacopoeia USP 1116 recognition of BFS as an aseptic process
• Significantly smaller footprint than conventional filling systems
• Exceptional process and product reliability
• Outstanding filling accuracy

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 sterile glass or plastic preformed 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.

In addition, Brevetti Angela’s SYFPAC shuttle-based solutions offer some highly useful specific user benefits that include:

• Custom Molds: molds exclusively produced by Brevetti Angela are based on customer specification of the final product and careful consideration of the polymers, products and chemicals that will be used. These allow ultimate flexibility to tailor shape, size and embossing of variable information to particular market needs. Molds are modular and can have up to 50 cavities, allowing production of different volumes with a simple change of inserts.
• Material flexibility: The unique SYFPAC® design allows the use of different types of polymer like PP, PE or HDPE without changing molds, merely entering a different recipe into the operating system, with no need to dismantle the mold or change any parts.
• Customization: Each SYFPAC® machine is uniquely configured to client specification, including options such as possibility of black and white separation, addition of inert gas, recirculation loop for suspensions, modification for temperature sensitive formulations, or inserts to emboss variable information.
• Market-friendly container formats: Custom-tailored shapes for the containers allow adjustment of head shape to specific product application, such as different types of luer connection on vials and ampoules, or twist off openings. For bottles, a particularly innovative example is the patented Eco-head design, which brings an eco-friendly and economic solution to large volume parenterals packaging by eliminating need for secondary capping.
• Parison Thickness Control: Thanks to its special engineering, SYFPAC® can control the wall thickness of the parison while extruding, allowing manufacture of containers from very rigid to those that are almost as lightweight and self-collapsible as flexible bags. This feature can reduce overall plastic consumption by up to 30%, compared to traditional machines.

Resources

Click on SYFPAC Videos to watch small and large cvolume parenteral systems in action.
Click on BFS Technology  for further explanation of the Blow-Fill-Seal process.
Click on SYFPAC® from Brevetti Angela for details of whole product range.
Click on BFS Containers for full range of package format options.