Quick conversion on the lock-and-key principle
Bausch+Stroebel and isolator specialist Skan have developed the versatile production modules VarioSys — a small, space-saving line for processing a wide variety of products and batches inside an isolator, in quick succession thanks to the extremely short conversion times.
The principle behind this new solution is extremely simple in practice: in a special isolator enabling production in cleanroom class A conditions, individual production modules can be installed that fit on the lock-and-key principle; for instance, a machine for processing syringes in nests or a filling and closing machine for vials. A freeze-dryer can also be integrated.
Installation effectively means that the respective production module simply slides out of the isolator like a work bench and can be replaced by another one. To ensure that the connection between the isolator and the production module is sealed securely and hermetically a special seal is inflated in the L-flange. The quick airlock SARA permits material transfers into and out of the isolator safely and effectively. There the decontamination with hydrogen peroxide (H2O2) runs completely independently of the isolator and only takes 15 minutes on average.
Available production modules are, for example:
- a production module that can be equipped with a wide variety of laboratory units or semi-automatic machines to suit the individual requirement.
- a fully automatic, universal machine for filling and closing (KSF 5105) or only for closing (KS 4105) bottles or vials at an output of up to 2000 containers per hour.
- a fully automatic, intermittent-motion machine for filling and closing ready-to-fill disposable syringes, vials or cartridges supplied in nests in tubs at an output of up to 4200 containers per hour (SFM5105). For this application an automatic tub unpacking system can also be connected to the system.
- further modules for stability tests, product formulation, etc.
To achieve maximum versatility, different dosing systems are also available; for example, peristaltic pumps or valveless rotary piston pumps can be used for liquid products or dosing augers for powder products. Single-use systems also present no problem. A special air routing inside the isolator also permits safe processing of toxic products.
Furthermore, the entire system is self-contained and can easily be moved to a different location. As it has no particular requirements on the site, it is immediately operational ("plug and play").
This time- and space-saving system for the production of small batches can be converted quickly, can combine highly differing components individually and can be adapted to suit changing situations by adding extensions — all for modest investment costs and (thanks to standardisation) short validation time.