Aseptic Filling One Way or Another, That Goes Into the Bag: A New Concept for Aseptic Filling of Infusion Bags

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Filling infusion bags with biopharmaceuticals and therapies using gene and cell-based active ingredients is demanding, which makes it a case for specialists. Harro Höfliger presents a new concept for aseptic filling of infusion bags which offers pharmaceutical customers a comprehensive carefree package.

Some people might think spontaneously of kangaroos when they see the term pouch, or the plastic bags you use in the supermarket at the fruit and vegetable section. But this probably does not apply to Christian Kollecker and Julian Grossmann. These two Harro Höfliger specialists associate something very special with the term — infusion bags, as used in artificial feeding, blood transfusions, cancer therapy or the very new area of cell and gene therapies. These special bags save lives. Whenever drugs are administered intravenously, these plastic containers are essential, so you see them everywhere in hospitals.

Infusion bags are becoming increasingly important worldwide. According to the World Health Organization, the number of cases where patients have to be given liquids intravenously is rising worldwide. This is another reason why this market segment is constantly growing, as Mordor Intelligence market researchers confirm.

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In their latest study the experts project the CAGR for infusion bags up to 2027 at 5.3%. The development of personalized medicine in particular is driving demand for customized bags, according to the researchers.

Aseptic Filling — a Case for the Specialists

There are only a handful of companies worldwide that are world leaders here, and Harro Höfliger is one of them. At Achema 2018 the specialty machine engineering firm had already presented a fully-automated line for aseptic filling and sealing of presterilized infusion bags. In the project with Hong Kong-based biotechnology company New Beta Innovations, the project engineers learned a lot about the fundamentals of aseptic filling for bags and hygienic design. That is knowhow that will now benefit other customers, that has been developed into a platform technology.

As Director Aseptic Technologies, Christian Kollecker leads the drive to evolve the concept, which was officially presented for the first time at Achema 2022. “Baxeptic represents our basic philosophy for aseptic machine engineering, that is, how we design and implement the machines,” he emphasizes. The trademarked word mark “baXeptic” promises the customer an integrated advisory approach with a customized system solution at the end of the project which precisely meets their needs.

One of the key issues here is to use preassembled modules which can be integrated into flexibly configured machine platforms, making a short time-to-market possible — all of this ranging from laboratory machines for small quantities up to series filling.

In recent years, Harro Höfliger has developed several suitable technologies: For example, the Aseptic Lab, a compact LOT platform for complex assembly processes with a dosing process, or the LRT platform for filling and sealing infusion bags in sterile conditions in the medium performance sector.

Hygienic Design is The Top Priority

Hygienic design is the top priority for machine builders. “The last step to the patient is the bag,” Kollecker clarifies. And this statement takes on a whole new significance if we consider that the new therapies in particular are based on active ingredients which cannot be terminally sterilized. The presterilized bags used for these must not be contaminated during the filling process, as this would endanger the lives of partially immunocompromised patients.

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The demands on machine building are accordingly high, and in recent years lawmakers have significantly raised the standards for GMP design. This applies to the GMP guidelines, and particularly Annex 1, currently under revision. This defines the guidelines for the manufacture of sterile products, prescribes barrier systems such as RABS or isolators, as well as robotic and monitoring systems, and is effectively the bible for sterile process technology. Naturally, people at Harro Höfliger know the requirements of Annex 1 inside out. They are the basis for concept and design of aseptic plants.

Asepsis is Familiar Territory for Harro Höfliger

Aseptic filling is familiar territory for the specialty machine engineering firm. Vials, syringes, autoinjectors or tubing — Julian Grossmann, Sales Manager Aseptic Technologies at Harro Höfliger, has seen them all, and knows from experience how difficult is to establish standards in the aseptic area. This is particularly true for infusion bags. What goes for one bag does not necessarily go for another! It starts with the materials, and ends with the medication it contains. For a long time, PVC bags dominated the market. Meanwhile, however, alternative materials such as EVA and PP are being used chilled or frozen storage for chemotherapy and parenteral nutrition. “Every customer project is individual,” Grossmann emphasizes.

This is how Harro Höfliger came up with the idea of developing a concept for aseptic bag filling which focuses on the customer and precisely fits the product and process. Nothing really new here, according to Grossmann: “At Harro Höfliger the customer defines the solution, not the catalog.” Among other areas, Kollecker and Grossmann are thinking about the new cell and gene therapies here.

These lifesaving forms of therapy often consist of long-chain biomolecules, living cells or lyophilized powders. As a result, filling them poses a number of challenges. The filling mechanism must be precisely matched to the therapeutic substance. Choice of methods depends on shear forces, pressure and many other parameters.

A further complication: The terminal sterilization already referred to is a no-go, the bags have to be absolutely pathogen and particle free inside and outside before filling, and remain so. Barrier systems such as isolators or RABS with gloves are basic equipment with the machines. Cleaning and decontamination procedures are also required to guarantee sterility throughout the entire process. A sophisticated pressure concept is also needed. Last but not least, the sealing process that closes the bag must be appropriate to the material and heat sensitivity of the contents.

There are plenty of innovative ideas for aseptic filling at Allmersbach: In the project with New Beta Innovation, the design engineers opted for an active open RABS barrier technology and the one-time docking principle with an aseptic triple filling head.

The connection to the filling needle is kept in place throughout all gas purging, evacuation and filling processes until the sealing of the bag. This minimizes the risk of particle entry and contamination. Residual oxygen content and headspace in the bag can also be controlled. The positive feedback from the market confirms the Baxeptic strategy, according to Kollecker. And for the future it should not just be the bag: It is also possible to process syringes and vials, possibly even with powdered products or combination products.

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