InInovative Process Solutions

Minimize product loss

In all areas of biotechnology, it is extremely important that the process-related product loss in aseptic filling lines is minimized. This applies to product development and clinical studies as well as to the production of personalized medicines, for example, for cell and gene therapies.

Under the name smartfill groninger offers process solutions that eliminate product losses during the start-up process, during production and at the end of a batch.

This includes various measures:

• A special priming mode that, in combination with a 100% In-Process-Control (IPC) available as standard, eliminates product losses during start-up.

• The permanent In-Process-Control (IPC) in combination with other measures prevents losses in the production process.

• The special run empty mode ensures that the mechanical filling process does not generate any losses at the end of a batch.

  

Safe transfer into the aseptic area

With groninger's safetransfer philosophy, it provides a safe process for introducting pre-sterilized components into the aseptic area.

The sterile introduction of RTU packaging into the aseptic processing area is an extremely critical process. From the proven process solutions that can be used depending on the situation and product requirements, groninger offers the right solution for every customer.

Feeding ready-to-use components

For the aseptic transfer into the A room (isolator, o-RABS or c-RABS), groninger distinguishes between different methods as part of the safetransfer philosophy. The decision for a certain procedure depends on various possible factors:

• batch sizes to be processed,
• products to be processed,
• planned capital expenditures (CAPEX),
• required installation space and
• ongoing costs.

A basic distinction is made between transfer methods with an external decontamination step on the one hand and the processing of double bags, the so-called no-touch transfer (NTT), on the other hand. At the NTT, the primary packaging is delivered sterile and transferred to the aseptic area (Grade A) via a defined process, supported by continuous germ and particle monitoring.

Easy changeover between formats and packaging

Making diversity possible: With the groninger combifill process solution, you have the option of filling nested ready-to-use syringes as well as vials and cartridges with a minimum number of format parts per system. The decisive factor is that the entire system can be completely changed over to different formats or packaging within a very short time.

With the possibility of operating different filling system on the lines increases your flexibility.

Component change without using tools

Changing components without the use of tools not only reduces set-up time, but also makes aseptic work much easier. With groninger's quickconnect concept, screw connections can be eliminated for all parts that come into direct or indirect contact with the formats or products.

All components or assemblies that have to be removed from a system, for example, to clean them or because the packaging is changing, can be removed with this system without using any tools.

The use of quickconnect can be made easier with an electronically guided installation aid. This not only enables GMP-compliant installation, but also prevents incorrect insertion. In this way, quickconnect saves the user up to 60% of the set-up time compared to traditional lines.

Universal sorting bowls

With our smarttrack technology, we ensure that the sorting of stoppers no longer takes place in the sorting bowls, but rather on the sorting tracks This means that a universal sorting bowl can be used for all types of stoppers instead of format-specific sorting bowls. Handmade sorting bowls with the associated long delivery times are a thing of the past.

Optimizing airflow

With innostream, groninger is breaking new ground in the field of GMP-compliant pharmaceutical machine construction. We made the optimal air flow priority. Innovative air flow on parts of the entire sorting unit that indirectly come into contact with the product is the core of our process solution. This reduces or even eliminates critical air pockets, uncontrolled air movements and the resulting undefined particle distribution.

Increasing flexibility of the lines

Flexibility is one of the most important requirements for today's filling lines. With the fastlane approach, groninger tries to meet these requirements and designs format parts in such a way that delivery times can be significantly reduced.