INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • With many of the blockbuster biologic drugs of the ’90s are coming off of patent, companies are racing to provide a clinically similar alternative to these pioneering products. Like any biologic drug, they require care and attentiveness throughout the manufacturing process. Therefore, it is necessary to maintain aseptic conditions throughout the production process of these drug products.

  • The big bag emptying stations of Dec are based on a modular design. This allows to be ideally equipped with systems for each product’s characteristics with corresponding docking systems for non-potent to highly active powders. Depending on the product flow, there is a range of discharge devices or lump breakers available. With the use of load cells, it is possible to dose accurately into the receptacle.

  • Used MG2 PLANETA 100 continuous motion capsule filler, nominally rated up to 100,000 capsules/hour, with touch screen HMI, vacuum system, serial# 4661, built 2010.

  • Our NP-400 is a 24/7 workhorse that features built in controls and off-the-shelf electronics. A self-lubricated turret and upper and lower cams reduce maintenance costs and provide longer operation time. The NP-400’s compact design is ideal for tablet manufacturers who need a reliable, efficient press to make up to 3,000 tablets per minute.

  • 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.