High Containment Granulation
High Containment with Maximum Safety for Minimal Volumes
It is precisely because of these requirements that Glatt has developed a containment solution in partnership with Weiss Pharmatechnik based on its wibo-barriersystem, which offers three possible configurations, depending on toxicity:
- Open Containment System (OCS): an open containment with a clean-air curtain for OEB4;
- OCS plus: an open containment with a clean-air curtain plus a sliding pane in compliance with OEB 5 and
- Closed Combined System (CCS): a closed total containment with a clean-air curtain and closed front screen complying with the requirements of OEB 5.
For years, Glatt has been producing apparatuses for weighing out, mixing, granulating, sieving, drying, and coating on a laboratory scale, so that the process technicians in Binzen can assemble a complete granulation line from powder to the finished tablet on a very small scale. The classic line for batch-run fluidized bed processes for testing agglomeration, drying, and coating processes is called Mini Glatt, and comes in three batch sizes ranging from 2.5 to 1,350 g.
Containment with Minimal Footprint
With high shear mixers, various process options in wet granulation can be tested. And if the optimum coating for new tablets with active ingredients needs to be tested, there are always the coaters in Glatt’s own GC series. “Thanks to the modular structure of the containment lab, we are able to adapt the laboratory workspace as required,” explains Maintok. Because of the mobile work benches, on which different laboratory equipment is put, it is possible to carry out several different processes within the same wibo-barrrier.
This reduces the footprint of the unit as a whole as well as the clean room costs. The work bench and the bench top unit are assembled in the Binzen technical laboratory. The containment lab cabin, which is connected to the work bench via pneumatic seals, is adjusted on site. An extraction system ensures that the sealed area remains clean during work. Cleaning between individual work processes is achieved with integrated CIP systems which capture particles, thus permitting contaminant-free transport to the washroom. Intervention is possible at any time through the glove ports in the front screen.