SOLID DOSE MANUFACTURING SOLUTIONS

• Pharmaceutical Preformulation Support Services

  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.

• Pharmaceutical Encapsulation Training Courses For The Pharmaceutical and Supplement Industries

  Immerse yourself in this comprehensive two-and-a-half-day training event that focuses on two-piece hard shell capsule filling for pharmaceutical and supplement manufacturing. Learn about the encapsulation process, common equipment, terminology, and gain practical knowledge with hands-on breakout sessions.

• Unused 600 Liter GEA High Shear Mixer

  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.

• A User-Friendly Solution For Fill-Finish Professionals

  When AST came to the table on the design for our new fill-finish isolator, one of the first areas AST engineers wanted to address was the usability and accessibility of the isolator and corresponding operations. With our customers’ point of view in mind, we wanted to address specific points of friction routinely encountered by operators and closely examine whether those friction points were necessary.

  Does an isolator need to be ergonomically unfriendly to clean?

  Should simple mechanisms like isolator doors be challenging to engage? (As much as one can appreciate exercise, no one wants to do “arm day” in cleanroom coveralls).

  Does routine maintenance have to be time-consuming and laborious?

  Many of these factors are accepted as par for the course in aseptic fill-finish manufacturing. Our question was, why?

• Pharmaceutical Containment Isolators

  Our Rigid Stainless Steel Containment Isolators have been designed for handling potent compounds that can offer guaranteed levels of operator protection as low as 10ng/m3 (task duration). These include designs for sampling, dispensing and sub-division, mixing, milling and vessel charging, as well as containing integrated process devices such as filter dryer units, tablet press enclosures, blenders, mills and pack off systems.

• Drug Product Manufacturing
• Containment: Bag In Bag Out
• Multiparticulates For Modified Release Systems
• Pharmaceutical Powder Handling Systems