What does “flexible production” mean in the context of pharmaceutical product filling?

Bausch+Ströbel answers this question by presenting the VarioSys modular production system

Bausch+Ströbel, the pharmaceutical packaging machinery company, has presented its VarioSys modular production system at Achema 2018 with a newly developed machine module for fully automatic tub opening and RTU vial denesting. The new feature makes the solution even more user-friendly, the company said.

The VarioSys is an established brand name in the pharmaceutical sector. Developed in collaboration with Böhringer Ingelheim, it essentially consists of two components:

  • a standardised SKAN cleanroom isolator
  • a similarly standardised, interchangeable machine module by Bausch+Ströbel which works on the key-lock principle.

The space-saving modular system owes its scope and versatility, in part, to the possibility for combining a specialty isolator with a range of different machine modules. In addition, multiple isolator chambers can be linked together in combination with sterilising tunnels, cleaning machines or a special GEA freeze-dryer to build a production line.

This means that VarioSys is just as suitable for small-batch processing in the laboratory as for use as a fully automatic, low-volume production line.

VarioSys machine modules can process vials, syringes, cartridges and ampoules, both as RTU containers packed in various makes of nest, tub or tray and as bulkware, in combination with a Bausch+Ströbel cleaning machine and sterilising tunnel.

Harro Höfliger’s product portfolio includes a suitable IV bag filling module. Depending on application, machine modules are available with various degrees of automation – from manual and semi-automatic to fully automatic. It is even possible to convert a laboratory system with manual handling steps into a fully automatic production line, or vice versa, at any time.

In-nest processing of vials

Thanks to a newly developed machine module for fully automatic tub opening and RTU vial denesting, VarioSys is now even more user-friendly.

This module comes equipped with cleanroom robots. Used in combination with the KSF5105 bulk filling and closing machine, it offers fully automatic in-nest opening, denesting, filling, stoppering, crimp capping and tray loading of RTU vials over a length of just meters, i.e. inside two isolator chambers.

The advantage is that nested vials can now be processed with 100% In Process Control (IPC) at maximum machine output (up to 60 tubs per hour). The module is designed primarily for processing RTU vials, but can also be used in combination with a nest filling module by deactivating the denesting function.

High-tech, small size

The modules meet exacting requirements within a tiny footprint. Although each production module is only 2 meters long and 1.5 meters wide, cutting edge drive and control systems provide aseptic-toxic filling and closing of RTU vials to the same high standard as industrial production systems – and using identical technology. This means that process data can be transferred between VarioSys and conventional B+S filling systems.

Versatility through interchangeable machine modules

“Bausch+Ströbel uses container-specific machine modules for the production process. This enables customers to achieve a higher level of process reliability with less expenditure on validation, as well as ensuring a highly robust production process,” explains Heiko Schwarz, the engineer in charge of VarioSys development in the Product Management department at Bausch+Ströbel.

"Versatility is always at the top of our minds. We achieve this, firstly, through fast and simple module changing, but also through short isolator sterilisation cycle times,” adds Schwarz.

“This degree of expandability ensures that our customers stay flexible and competitive in the long term,” adds Lukas Bindewald, B+S product manager with responsibility for VarioSys.

Low cost of investment thanks to standardisation

A time and space saving system for small-scale production, VarioSys can not only be converted easily – it can also combine a wide variety of components individually and can easily be adapted to new requirements by adding extensions. Moreover, this can be done with a minimum of investment and (thanks to standardisation) with short qualification and validation times: a major advantage in the race to bring new developments to market.