INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • Closed RABS as a housing for aseptic processes, e.g., filling, loading, and unloading of freeze dryers. Product protection is achieved through a barrier (cRABS housing with gloves) between the operator and the product.

  • 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.

  • 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.

  • Ensure sterile compliance and safety by understanding proper airflow and pressure dynamics in your compounding workflow. Choose the right hardware for your facility.

  • Dec has designed a wide range of versatile and low cost flexible containment solutions such as disposable glove bags, complete flexible enclosures and semi-rigid isolators suitable for many operations whether it be formulation plants including dispensing and granulation or around tablet pressing machines for both R&D and production facilities.