INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • 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.

  • Explore an encapsulator with accurate operation for orientation, separating, filling, closing, and ejecting capsules along with sensors to control powder, pellets, and capsules.

  • Used Sejong rotary tablet press, model GRC-15C, 15 station, D tooled, 6 kn main compression, 2 kn pre compression, 25 mm max tablet diameter, 22 mm max depth of fill, with feed hoppers, rated up to 67500 tablets/hour, with integrated controls and touchscreen interface, serial# ST17866, built 2017.

  • Used A Berents BECOMIX planetary mixer, model RW 30, stainless steel construction, 60 liter total capacity, 30 liter working capacity, chamber rated -1/2 bar(-14.5/29 psi) at 134 c internal, jacketed for 4 bar(58 psi) at 152 c, top mounted variable speed agitator with side wall scrappers, bottom mounted homogenzier, dome top with lift/lower mechanism, cone bottom, with on board controls and external control panel, 3/50/400 volt, Fabr# 011/1-586, built 1996.

  • The production and handling of highly potent sterile APIs within a multi-purpose designed plant are becoming more and more prevalent within the pharmaceutical industry.