Pelletizing

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.

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.

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.

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.

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