Rommelag BFS Aseptic Fill & Finish Solutions

March 19th 2020

The Rommelag Bottelpack process for combined manufacture and filling of Blow Fill Seal (BFS) containers is ideal for aseptic filling and finishing operations, using purpose formed plastic bottles and ampoules.

These aseptic filling machines can be combined with Rommelag Particle/Cosmetic inspection, Container Closure Integrity systems and cap welders to create entire pharmaceutical and biotech aseptic packaging lines within very compact environments.

BFS aseptic filling systems

The key challenge in aseptic pharmaceutical manufacturing is to package an aseptic liquid with the highest aseptic assurance level possible. Primary packaging is the final step in the original manufacture or aseptic contract manufacturing process, providing the product with a hermetically sealed environment, shelf stability and protection from the outside environment.

A Rommelag bottelpack® aseptic system based on blow-fill-seal (BFS) technology provides the ideal safe and cost-effective solution for aseptic packing of liquid and semi-solid pharmaceutical products, killing three birds with one stone: container production, sterile filling and hermetic closure of the container in one operation performed in a controlled environment and completed within three to 16 seconds (depending on container size and machine type), with up to 30 containers finished within one cycle.

Blow-Fill Seal was invented by Rommelag more than 50 years ago and marketed worldwide under its bottelpack® brand.

BFS is an advanced and automated aseptic process that performs primary packaging for a wide range of products, including nebulized inhalation drugs, ophthalmic OTC products and drugs, small and large volume injectable products and cosmetic and household products.

Since the BFS container is created from resin inside the machine, there is no upstream container handling, empty container transport or storage prior to filling. Depalletizing, descrambling, accumulation, washing, and depyrogenation are also eliminated from the process.

Bottelpack technology allows unique container designs to be produced, with positive handoff to downstream secondary packaging systems. Off-the-shelf container designs include fills from 50 microliters to more than 1000 mL.

A growing area in pharmaceutical packaging development is aseptic liquid filling of medical devices. Here the BFS container is designed to fit into a device and supply an aseptic liquid. The BFS container can work as an aseptic cartridge that is disposable or fully integrated into a single use device. It is also possible to insert a device into a container.

Rommelag has developed a cold aseptic bottelpack solution for aseptic pharmaceutical manufacturing applications for temperature-sensitive pharma or biotech products, such as vaccines.

Adding value to BFS aseptic manufacturing

To ensure that contents can be packed first-class and delivered completely safe to any destination, Rommelag Engineering has supplemented its bottelpack range with various inspection systems that work throughout the aseptic packaging process with maximum safety and cost-effectiveness.

To meet the challenges of digitalization within increasingly regulated environments, Rommelag offers a highly sophisticated solution for integration, operation, support and maintenance of bottelpack aseptic systems in existing or new plants. The new Rommelag Pharma Platform addresses digitalization benefits while honoring regulatory compliance criteria by allowing seamless integration of a bottelpack system into the production floor network via standard OPC UA communication. This offers a flexible connection to line management tools like a manufacturing execution system (MES) for automated batch control or an archive for storing process critical data. Efficiency metrics such as overall equipment effectiveness (OEE) and additional configurable electronic reports allow better insight into the production process to identify bottlenecks.

For up-to-date maintenance and support as well as overall machine improvement, Rommelag offers a 100% one-way data flow, which allows secure connectivity to transfer dedicated data sets into external networks while leaving the validated system untouched. Other features now securely available online include a machine catalogue to browse and select spare parts, access to additional technical information, remote diagnostics and advanced maintenance options.

Rommelag BFS aseptic technology advantages

BFS packaging uniquely facilitates fully integrated production of user-friendly containers. When it comes to ampoules, for example, these can be manufactured with an integrated Luer connection, enabling secure and direct needle-free connection to a syringe.

For more complex aseptic filling systems, Rommelag aseptic bottle filling machines can incorporate a wide range of appropriate droppers, valves, and infusion caps. The blow-fill-insert-seal process can also be supplemented with inserting components to provide additional functionality.

Advantages of BFS technology for aseptic filling processes include:

  • Fully automated processes for aseptic manufacturing, filling, and sealing
  • Exceptional process and product reliability
  • Outstanding filling accuracy
  • Break-proof, user-friendly containers
  • Diverse container shapes and sizes
  • Straightforward adaptation to specific applications and administrations
  • Suitable for sensitive formulations
  • ISO Class 5 safety approved
  • Easier aseptic filling process validation: EMA & FDA aseptic filling approved
  • USP 1116 recognized advanced aseptic process
  • Significantly smaller spatial requirements than conventional filling systems.
Rommelag BFS Aseptic Fill & Finish Solutions

Rommelag aseptic filling bottelpack® installation with control cabinet (left)