Integrated vial filling machine for aseptic and toxic processing of pharmaceuticals
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.
Pharmaceutical vial processing taken to a new level
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 integra concept
Highest machine efficiency
The integra is specifically designed to minimize product loss in all phases. When starting up, the first vial per filling point is already filled with the specified volume; when running empty, the pumps can be controlled individually so that only the last filled vial per filling point could show an underfill.
To further minimize product rejects, the integra can be designed with a stopper repositioning function, allowing to the loss of a stopper to be compensated by repositioning it.
Shortest changeover times
Our stopper transport bowl can convey all common plugs, the sorting only takes place in the integrated sorting device, which can be aseptically removed without any problems. This reduces the number of stopper-dependent format parts and, as a result, enables the shortest set-up times for changeovers. The sorting and feeding unit is easy to clean and easy to see.
The walking beam can be adjusted using a servo motor and can be set up for different processing objects. This way the number of format parts that would otherwise have to be changed is reduced by around 50% compared to conventional production lines.
Versatile application areas
The low machine depth of the integra allows one-sided air extraction in the filling and discharge area. The filter cartridges are attached to the back of the isolator.
For toxic product processing, the entire line is equipped without vacuum. A mechanical stopper setting function, a mechanical rejects ejection and the avoidance of bellows seals allow the optimal processing of toxic products and the necessary cleaning.
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
With the integra, the sterile barrier is integrated into the filling machine; this is is where the proven SKANFOG decontamination technology comes in to play. In combination with the compact design of the entire system, it allows to achieve the shortest cycle times.
Filter arrangement and filter change
With integra, the HEPA filters are installed in filter cartridges, the so-called FIPAs. The cartridges can be unlocked manually or fully automatically via the panel control. This is particularly important for toxic processing: Due to the design, there is never a risk of contamination for operating personnel or the environment.
- Effective line speed of 200 to 400 objects/minute
- 100% In-Process-Control (IPC)
- Minimum residual oxygen content of =1%
- All common gassing functions
- All common standard filling systems
- 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
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.