Today, 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 and a similarly standardised, interchangeable machine module by Bausch+Ströbel which works on the key-lock principle.
This space-saving modular system owes its tremendous scope and versatility in part to the possibility of combining a speciality isolator with a range of different machine modules. In addition, multiple isolator chambers can be linked together to build a production line in combination with sterilising tunnels, cleaning machines or a special GEA freeze-dryer. This means that Variosys is just as suitable for small-batch processing in the laboratory as it is 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 the 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 special cleanroom robots. When used together 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 four metres, 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 in a small package
The modules meet exacting requirements within a tiny footprint. Although each production module is only two metres long and one-and-a-half metres 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 has the benefit that process data can be transferred between Variosys and conventional B+S filling systems.
“We use 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 changes but also through short isolator sterilisation cycle times”, he adds.
Another important consideration for Schwarz is the system’s ease of expandability. “Variosys is not so much a machine but a system solution. For example, a system originally used solely for bulk processing can also be used to process RTU syringes by adding a nest filling module. What’s more, the line concept can be expanded subsequently to include additional isolators, machine modules and freeze dryers”, he explains.
Low cost thanks to standardisation
As 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 or be adapted simply to new requirements by adding extensions. Moreover, this can be done with a minimum of investment as well as (thanks to standardisation) short qualification and validation times – a major advantage in the race to bring new developments to market.
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Author: Lukas Bindewald
Product Manager,
Bausch+Ströbel
