Hot Melt Extrusion

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;...

Precision filling of dry granulates into bottles using gravimetric and volumetric dosing, integrated bottle cleaning, camera inspection, induction sealing and torque-controlled capping, ensuring uniform fill weights under cleanroom and GMP conditions.

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.

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.

Accurate powder filling into bottles and containers on Optima machinery with in-process checks, suitable for both clinical and commercial scales, in a GMP compliant packaging facility.

Tablet sugar coating in dedicated 120 L and 250 L pans with customizable process steps, combining automated and manual techniques to deliver uniform sugar shells meeting pharmaceutical quality demands.

Precise single- and double-sided tablet imprinting using R. W. Hartnett Delta-Printer and Agate S printer technology to apply logos, batch numbers and text on various tablet shapes and coatings.

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