Granulate Filling

Robust mixing of APIs and excipients using high-shear blenders (Diosna P600, VAC 10+60) and free-fall blenders (Bohle PM-series) in both development (0.5–150 kg) and commercial manufacturing (2–750 kg) to achieve uniform blend homogeneity.

High-speed blister packaging on 13 fully automated lines (Uhlmann BEC 300/500, IMA Giant), handling PVC/PVDC, Alu-Alu, ACLAR® and PP foils with serialization and aggregation capabilities in a GMP certified cleanroom environment.

Automated bottle filling on three Uhlmann IBC 120/150 lines and one powder-filling line (Optima), including counting, induction sealing, torque-controlled capping and 100 % in-line inspection, all under GMP compliance.

GMP-compliant production of Phase I–III clinical samples (0.5–150 kg) in an FDA-approved pilot plant, with dedicated project teams for formulation, process upscaling and analytical method support.

Tablet film coating on seven dedicated coaters (All scales available: Bohle BFC 5, BFC50, BFC400, BFC600) for aqueous and organic solvent processes, with automated parameter control and full process documentation in a GMP-certified environment.

Formulation and process development for oral solid dosage forms from lab and pilot scale to commercial production (0.5–150 kg) in a GMP/FDA-approved pilot plant; includes dry-, fluid-bed- and wet granulation, hot-melt extrusion/melt granulation, tabletting, filmcoating, mini-tablet and pellet technologies;...

End-to-end granulation services including fluid-bed (GPCG series), high-shear (Diosna series) and dry roller compaction (Gerteis Mini- and Macropactor) for batch sizes from 1 to approx. 750 kg, all conforming to GMP requirements.

Handling of high-potency APIs with an OEL values from 1µg/m³ onwards is dpendent on drug load and manufcaturing process. Rottendorf will invest into high potency for handling compounds with an OEL value of 0.1/m³.

Continuous melt extrusion using co-rotating twin-screw extruders (Leistritz ZSE 18HP) enabling enhanced solubility and controlled-release pellet formation.

Solvent-free hot melt granulation with heated hoses and nitrogen circulation to improve bioavailability of poorly soluble APIs.

Production of bi-layer tablets on Korsch and Fette Euro B/D rotary presses (Korsch X3 XL200, XL800, Fette F55) with fully instrumented process control, enabling complex dosage forms under robust quality standards.

Extrusion and spheronization with GEA NICA E140/S450 and bottom-spray Wurster coating (Aeromatic MP 3/4) to produce sustained-release and multiparticulate pellets.

Faster time to market: Integrated early-development offering and accelerated commercial pathway for biotech companies.