Quickly bring new developments to market with VarioSys

VarioSys: A very flexible and additionally space- and time-saving system for small batch production. Multiple components can be arranged in a production line depending on the requirements.

The principle of VarioSys is conceptually simple in application: In a special isolator, which enables production under cleanroom class A conditions, individual production modules can be installed according to the lock-and-key principle.

When specialized biotechnological active substances are produced and processed into parenteral, i.e., sterile medicines, the batches are often small, and the production processes must frequently be adapted to new products, different dosage forms, and fill volumes. Combining this high variability with the necessary cost-effectiveness is made possible by an innovative concept of isolators, which can be equipped with various production modules and connected into process chains very flexibly. This system is called VarioSys, developed by the South German special machinery manufacturer Bausch+Ströbel together with the isolator specialist Skan (Switzerland), and will be presented with further new application possibilities at Interpack 2017 in Düsseldorf.

The starting point for development was the company Boehringer Ingelheim Pharma, which was seeking flexible production solutions for its US site in Fremont, California. The requirement: a very flexible system that allows the production of different dosage forms such as pre-filled syringes, cartridges, and vials with varying fill volumes within a single isolator, without the need to install separate filling and sealing machines with their own isolators for each application system, as was previously common.

Extremely simple principle: flexible isolator combined with production module

The principle of this new solution is remarkably simple through the combination of various machine modules and flexible isolators. The respective production module—whether it is a system for processing syringes or cartridges in nests, or a filling and sealing machine for vials—can be easily pulled out of the isolator like a work table and replaced with another.

Possible production modules include, for example:

- a module that can be equipped with various laboratory devices or semi-automatics tailored to specific requirements.
- a fully automatic machine for filling and sealing (KSF 5105) or sealing (KS 4105) bottles or vials with a maximum capacity of 3,600 objects per hour.
- a fully automatic, synchronized machine for filling and sealing ready-to-use prefilled syringes, vials, or cartridges in nests and tubs, with a maximum capacity of 4,200 objects per hour (SFM 5105).

At Interpack, a module for processing ampoules (AFV 5105) and a module for filling bags (developed by B+S partner Harro Höfliger) will also be showcased. Further modules are conceivable for product handling, sterilization testing, etc.

Furthermore, numerous different dosing systems ensure maximum flexibility. For example, peristaltic pumps, valve-less rotary piston pumps for liquids, or screw dosing units for powder-like products can be used; the use of single-use systems is also easily possible. A special air guidance system within the isolator also allows for the safe processing of highly potent or toxic products.

The safe and efficient loading and unloading of RTU material into and out of the isolator is facilitated by an automatic tube unpacking machine (TUM) or the quick access SARA. Their fully automatic decontamination, independent of the isolator, is carried out with hydrogen peroxide (H2O2) and takes on average only about 15 minutes.

It is also possible to connect various VarioSys modules in line and combine them with a freeze dryer from GEA, cleaning machines, and sterilization tunnels from Bausch+Ströbel.

Users are now more flexible in many ways

Users are now more flexible in many respects. On the one hand, with VarioSys, it is no longer necessary to invest in additional cleanrooms and airlocks. Moreover, the investment costs are reduced because each isolator can be combined with various modules.

For a corporation like Boehringer Ingelheim, whose locations are worldwide, this is also important: the entire system is self-contained, can be set up very easily at another site—without lengthy qualification and validation times. Since it can be installed in an ISO7/Class C cleanroom, it is very quickly operational according to the plug-and-play principle. Thanks to the standardization of the modules, fast delivery times are also guaranteed.

For the production of smaller batches, VarioSys offers a very space- and time-saving system that can be quickly reconfigured, with various components that can be combined very individually, and that can be easily adapted to changed requirements through extensions—at low investment costs and with minimal qualification or validation effort thanks to standardization. A crucial advantage for quickly bringing new developments to market.