Form Fill Seal is an innovative, automated process in the packaging industry. Based on specialized high-performance pharmaceutical films, such as those developed at Rommelag FLEX, the FFS process creates flexible bags for the aseptic filling of pharmaceuticals, chemicals, and cosmetics. Immediately after the packaging is formed and the product is filled, thermal, hermetic sealing takes place directly within the process. This reduces the risk of microbial contamination to a minimum, which is particularly required when filling parenterals (LVP/SVP) and specialty chemicals. Furthermore, the combination of the aseptic process with barrier material properties that minimize permeability often allows for the omission of preservatives.
While Rommelag is known in mechanical engineering as the world market leader for Blow-Fill-Seal (BFS) technology, the FFS portfolio ideally complements this offering for applications requiring highly flexible primary packaging.
The technology is characterized by high output, leading to an increase in Overall Equipment Effectiveness (OEE). This applies not only to the use of aseptic filling lines in one's own operations. Rommelag CDMO also offers this efficiency advantage: companies can outsource the aseptic filling of their products to our specialists and thus benefit from state-of-the-art technology. Based on operational requirements, customers choose the proven Form Fill Seal technology or the Blow Fill Seal process to increase productivity and simultaneously reduce costs.
What are the differences to the Blow-Fill-Seal process?
In the aseptic filling of pharmaceutical products, the Blow-Fill-Seal (BFS) process has proven itself for decades. Rommelag was a pioneer in the industry with the introduction of this technology. To this day, BFS technology and the Form Fill Seal (FFS) process meet the highest requirements for efficient and safe packaging in break-resistant containers.
The forming of custom-fit BFS ampoules and flexible bags in the FFS process, as well as their subsequent filling, take place in a continuous process. This enables the aseptic filling of large product volumes in a short time. FFS and BFS differ in the way the packaging is manufactured. While the machine extrudes rigid or semi-rigid bottles and ampoules directly from granulate in the BFS manufacturing method, flexible bags are produced in the FFS process from a pre-fabricated film made of PE, PP, COC, or high-performance multi-layer composites. With Rommelag FLEX, specialized film solutions are available that exceed the standard of conventional industrial films.
In BFS packaging units, the inside of the container is only created during extrusion from the hot melt, making it inherently sterile. In FFS bags, the film web requires targeted sterilization before the filling process. Since BFS technology guarantees a level of sterility assurance that fully complies with the requirements for highly sensitive products according to EU-GMP Annex 1, it is often regarded as the preferred method in areas such as ophthalmics or injection solutions (Advanced Aseptic Processing).
Advantages and Disadvantages of the Form-Fill-Seal Process
Many companies utilize the advantages of this proven process for packaging sensitive goods:
- Minimal risk of contamination
- No use of preservatives necessary
- Flexible design of packaging shapes and sizes
- Increase in Overall Equipment Effectiveness (OEE)
- Reduction of production costs
- Reduced logistics and storage costs due to low tare weight and high break resistance
Small packaging units can be realized with the Form Fill Seal process just as easily as bags with a volume of up to two liters. The optimization of the process through fast, aseptic filling leads to high efficiency while maintaining the highest quality.
Bundling all work steps into a single production process leads to a significant reduction in production costs. Furthermore, the space-saving bags occupy only a small volume in storage, leading to further cost savings.
In the packaging industry, high gas permeability is generally considered a disadvantage. In this regard, Rommelag’s technology is outstanding. Packaging solutions are available for every application that minimize permeability and thus ensure the stability of the active ingredient until the end of its shelf life (expiration date). In addition, the following material properties have a favorable effect:
- Easy handling
- Flexibility
- Break resistance
In which areas is the Form-Fill-Seal process used?
Form-Fill-Seal bags are ideal for the aseptic filling of pharmaceuticals. FFS bags are particularly suitable for containing:
- Parenterals: Large volumes (LVP) such as infusion solutions in flexible bags.
- Biotechnology: Aseptic filling of sensitive biologics that benefit from the barrier properties of multi-layer composites.
- Clinical Nutrition: Secure protection for oxygen-sensitive vitamins and nutrients through minimized permeability.
Form Fill Seal and Blow Fill Seal – a successful combination of efficient packaging solutions
The Form-Fill-Seal process represents an excellent addition to Rommelag's Blow-Fill-Seal packaging. In pharmacy, BFS is considered the "gold standard" for sterility assurance. The strengths of FFS lie in flexible bags made of multi-layer composites. These are suitable as infusion bags that require specific barrier properties. The application of both packaging processes is convincing in aseptic filling and quality protection.
Not least, the highly efficient integration of the process is advantageous. The seamless chain of forming, filling, and cohesive sealing enables maximum output in minimum space. Whether through the implementation of specialized FLEX films in existing lines or the utilization of CDMO capacities – Rommelag optimizes your value chain through technological excellence.