INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • Building on the capabilities of the NP-RD10A benchtop tablet press (discussed in our previous article on USP <1062>), our services are further enhanced by the integration of the Presster™ compaction emulator. This state-of-the-art tool is designed to replicate the compaction dynamics of production tablet presses in a laboratory setting. It allows for tangible fine-tuning of the compression cycle, providing an accurate depiction of how a tablting formulation will behave under commercial manufacturing conditions. Using the Presster, Natoli Scientific can simulate full-scale production, permitting us to forecast problems before they escalate to costly production delays. Our experts can optimize the tablet design for our clients, ensuring a smooth transition from laboratory to production while adhering to the rigorous standards set by the industry including the current USP <1062> chapter.

  • Used 79 gallon (300 liter) Inox reactor, stainless steel construction, approximately 24" diameter x 34" straight side, dish lid top with dish bottom, jacket and interior rated 30 psi and full vacuum at 300 F, 6" top access, with (1) 4", (1) 3", (2) 2" and (2) 1.5" nozzles on top, with bottom entering magnetic agitator, .75 hp with controls, 1.5" center bottom outlet, with load cells, all on portable frame, serial# 95011-2, CRN# K82555, built 1995.

  • Ropack Pharma Solution’s ample, nimble capacity and validated processes bring quality and reliability to encapsulation.

  • Eurofins CDMO Alphora handles small molecule APIs and HPAPIs from IND-enabling through commercialization, with FDA and Health Canada-approved facilities scaling up to 125 kg per batch. Contact them to discuss your program.

  • Unused 600 liter GEA high shear mixer, model PMA 600 Advanced, 316L stainless steel product contact surfaces, 240-450 liter working capacity, 36 kw main impeller, 1-170 rpm, 11 kw chopper, 1000-3000 rpm, jacketed bowl, machine designed to 16 bar shock rating, full vacuum rated bowl, 8" side discharge with valve, integrally mounted Quadro Comil, model U20, integrally mounted blade hoist, associated control systems with Allen Bradley plc and HMI designed for class 1 div 2 area, 480 volt, with GEA temperature control unit, model PMS 600, WIP design, through the wall design mounted on base with PL600 IBC hoist with (4) approximately 750 liter IBC's, PMA 600 Advanced serial# 14369.1310, built 2015 and unused.