Integrated vial filling machine for aseptic and toxic processing of pharmaceuticals
Vial filling machine and isolator technology as an integrated concept solution: This is the approach behind the integra concept. The result is a line in a purist design that is characterized by the merging of previously separate functional units into a well thought-out overall concept.
A new level of pharmaceutical filling of vials in bulk
The reason for this is simple: The processing of aseptic and toxic products in the pharmaceutical industry, especially in the biotech sector, places special demands on line construction. With the concept developed jointly by groninger and SKAN, we make all of this possible:
- reduced hazard potential for operating personnel,
- optimized machine design,
- the line is easily accessible for easy operation and cleaning and
- as short as possible changeover times.
We have systematically secured the interfaces between the groninger and SKAN lines so that you will find an established market standard here that can be used without any risks.
And the concept is convincing: More than half of our integra customers are CMOs and CDMOs - a clear sign for us that the well thought-out machine concept has proven its worth!
Highlights of the groninger integra concept for filling vials
Highest machine efficiency
The integra is a state-of-the-art vial filling machine designed to minimize product loss at every stage of production. From the moment it is started up, the groninger solution ensures that the first vial per filling head is already filled with the exact volume required. This ensures that there is no wastage of precious product during the initial stages of production.
As production continues, the pumps can be controlled individually to ensure that only the last filled vial per filling head could show an underfill. This means that even if there is a malfunction in the system or an issue with the pump, the product loss is kept to an absolute minimum.
To further reduce the risk of product rejects and minimize waste, the integra can be designed with a stopper repositioning function. This allows for any loss of a stopper to be compensated by repositioning it in the system. With this function, the integra ensures that every single product is of the highest possible quality, while minimizing any unnecessary waste.
Shortest changeover times
Our stopper transport bowl is not only innovative, but also highly efficient. The integrated sorting device allows for easy cleaning, making it a breeze to maintain aseptic conditions. Furthermore, the reduced number of stopper-dependent format parts means changeovers can be performed quickly and efficiently, saving valuable time and resources.
But that's not all. The sorting and feeding unit is designed with optimal visibility in mind, ensuring that operators can easily monitor the process and make adjustments as necessary. And with the walking beam's ability to be adjusted using a servo motor, the machine can be configured for various processing objects, resulting in a 50% reduction in format part changes compared to traditional production lines.
The stopper transport bowl of the integra is truly versatile and adaptable, providing a streamlined and efficient solution for your production needs.
Versatile application areas
The Integra's low machine depth makes it possible to extract air from one side in the filling and discharge area, with filter cartridges attached to the back of the isolator. Additionally, the entire line is equipped without vacuum for processing toxic products. The mechanical stopper setting function, mechanical rejects ejection, and avoidance of bellows seals ensure the optimal processing of toxic products while keeping the necessary cleaning requirements in mind.
The slim machine design of the entire system is an essential element of the integra. The low depth of intervention makes it possible to operate the entire system from one side, during setup and during operation.
The low machine depth of 650 mm also makes it possible for all line areas to be easily reached during cleaning. The line can also be set up at an angle allowing the cleaning medium to drain directly into a drain located on the back of the isolator directly in front of the HEPA filter cartridges.
SKANFOG decontamination technology
The integra filling machine is a game-changer in the pharmaceutical industry, as it seamlessly integrates the sterile barrier into the filling process. This innovative technology not only streamlines the filling process, but also ensures the highest level of sterility for the final product. To achieve this level of cleanliness, the integra employs SKANFOG decontamination technology, which has been proven to effectively eliminate any potential contaminants.
What sets the integra apart from other filling machines is its compact design, which allows for the shortest cycle times possible. This means that the entire filling process, from decontamination to filling, can be completed in a fraction of the time it would take with traditional filling methods. By reducing the time needed for the filling process, pharmaceutical manufacturers can produce more products in less time, ultimately increasing their productivity and profitability.
Filter arrangement and filter change
integra's innovative design ensures that the HEPA filters are securely installed in filter cartridges called FIPAs. These cartridges can be conveniently unlocked either manually or with the fully automated panel control. This feature is especially critical when dealing with toxic materials because the design guarantees that there is no risk of contamination to the environment or operators. Hence, integra provides a safe and reliable solution for hazardous processing, ensuring a healthy and hazard-free environment for everyone.
Specifications of integra
- 100% In-Process-Control (IPC)
- Minimum residual oxygen content of =1%
- All common standard filling systems and gassing functions
- Re-closing function
- Vacuum-free line for toxic products
- Minimum product loss in infeed and idle mode thanks to groninger smartfill technology
- All common barrier systems
- Highest operator and product protection in aseptic toxic processing
- Innovative ergonomic design and easy access allow cleaning and operation from one side
- Reliable airflow between two barrier-forming HEPA filters
- Fastest cycles with the latest SKANFOG® decontamination technology (H2O2 cycle time 1 hour < 1 ppm)
- Integrated NANOX® catalyst technology from SKAN (one-pass degradation of H2O2; 0.1 ppm)
- Validable and repeatable cleaning procedure
- Automated, safe HEPA filter system (“FIPA”) change
This is what our customers say
With the integra, we combine a smart, efficient and digitized line with our existing equipment. Thanks to the sophisticated solution, we can triple our production capacity.
The groninger expertise in bulk filling lines especially for CMOs and our know-how in drug manufacturing resulted in a great cooperation and partnership our clients benefit from.