Powder Filling

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.

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.

Tablet compression on Euro B/D rotary presses (Korsch, Fette, etc.) for single, double-layer tablets, plus capsule filling on Bosch GKF series machines with 100 % weight control, from development to commercial scale.

Comprehensive analytical services from method development and transfer to routine testing of raw materials, excipients and finished products in a GMP/FDA-certified laboratory, leveraging over 180 experts and advanced techniques (HPLC, GC, dissolution, Karl Fischer, ICP, TLC, etc.) to ensure regulatory comp...

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.

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