Visitors to the Europharma stand at the PPMA Total Show could discuss the flexible benefits of the VarioSys system which has been developed by Bausch+Ströbel. In essence, this production system for biotech and pharmaceuticals is a combination of two elements: an isolator made by SKAN and machine modules made by Bausch+Ströbel and Harro Höfliger. The system has been designed to provide the utmost flexibility in the production of medications by the ability to change modules, depending on the product being packed and into which packaging format. These machine modules are simply slotted into place on the ‘lock-and-key’ principle and plugged in.
Meanwhile, pharmaceutical production can be extended by adding a suitable freeze-dryer made by GEA.
VarioSys is suitable for a wide range of applications including the manufacturing of clinical samples as well as the production of batches, in one installation. All FDA requirements for pharmaceutical production are met by the process.
Maximum flexibility for small batch aseptic manufacturing and laboratory applications is delivered by the isolator. It is ideal for:
- Commercial manufacturing
- Clinical filling
- Filling personalised medicines
- Flexible contract manufacturing
- Small batch manufacturing
- Product development
- Start-up/Scale-up, and
- Process development.
At the exhibition, Martin Kern, senior consultant from Bausch+Ströbel talked about the plug and play nature of the development which can be adapted to various packaging materials.
“This modular system, which allows each module to be changed quickly, future proofs the equipment for changing needs,” he said. “It also means manufacturing can take place from a small footprint without the need for a cleanroom environment.”
The new version of the VarioSys-isolator (PSI-L 2.0) features integrated catalytic converters, highly efficient filter cartridges (FiPa), and the patented SKANFOG Flow system. Maximum process safety is ensured by reliable cycles with lower H2O2 consumption, and, above all, a significantly reduced cycle time for the entire system.
The new design is also very simple to clean and operate.
All these features, coupled with the special L-shaped flange that enables a very quick exchange of precisely tailored modules, ensures a universal sterile working environment for aseptic and/or highly active pharmaceutical products. For highly active products, the system also has suitable options so that the process can be implemented safely.
The modules’ wide range of combination possibilities mean that the requirements of the most varying production processes can be fulfilled, says UK distributor Europharma. The modules can be easily and quickly exchanged inside the isolators. Depending on the production process, the system can be loaded via a mousehole, the quick airlock SARA-XL, or a sterilisation tunnel.
The process output can be realised via a mousehole, the airlock or a bag-out system. Furthermore, one or more freeze dryers of different sizes can be integrated to form a valuable and flexible production system.
“The simple engineering work offered by this equipment also brings time to market benefits for new drug products,” explains Peter Kierans managing director at Europharma.
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