INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • Used ThermoScientific Haake Pelletizing line, with model Phama 11 HME twin screw extruder, item# 553-0020, co-rotating screws, 40:1 l/d, 1000 rpm screw speed, 1.5 kw motor drive, with feeder, and operator HMI touchscreen. ThermoScientific Ph11 Conveyor, item# 553-0600, serial# 1-21004125001. ThermoScientific pelletizer, 6 blade rotor with pull roll, 230 volt, CE design, extruder machine# KU18-000011, serial# 1-1800319001, built 2019.

  • Natoli Engineering’s NP-P20A single-station hydraulic tablet press is a favorite for the production of injectable micropellets and for marginal formulations requiring deep-fill. The NP-P20A meets the FDA’s requirements for batch reporting and secure data management under CFR 21 Part 11 compliance.

  • 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.

  • Partner with Natoli Scientific during the earliest stages. Our scientific expertise with state-of-the-art analytical capabilities is ready to take any preformulation challenge.

    Natoli scientific has an expertise of handling a wide range of APIs for the development of oral solids. We apply principles of ‘Quality by Design’ to define Critical Material Attributes (CMA), Critical Process Parameters (CPP), Critical Quality Attributes (CQA) and Quality Target Product Profiles (QTPP). Because we believe that understanding material and process as much as possible in the early life cycle of drug product development program is an insurance for further development path. Keeping your practices up to date with the ICHQ8 regulatory guidance issued by the US FDA. This is also a gate way for a smooth ride of product in the different stages of product development stages.

  • Master the art of tablet manufacturing with our comprehensive hands-on seminar, designed to equip you with in-depth knowledge and skills required for pharmaceutical and supplement manufacturing. This two and a half-day course covers essential topics such as tablet press setup, powder preparation, formulation, excipients, API, direct compression, wet granulation, dry granulation, tablet press operation, compaction, lubricants, and quality control.