INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • The aseptic/sterile Fill-Finish equipment solutions need to be cGMP compliant, dependable and accurately designed to comply with the most recent revisions of the “Annex 1 Manufacture of Sterile Medicinal Products guidelines”. Newly designed equipment needs to accommodate for small batches, various speeds and containers, including RTU / RTF (Ready To Use or Ready To Fill) bottles, vials, cartridges, syringes and pre-sterile nested trays. Moreover, the filling equipment solution should also improve the ergonomic use for operators and maximize cleanroom efficiency.

  • 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.

  • Used IMA Zanasi 6 F Capsule Filler, rated up to 6000 capsules/hour, no change parts, capable of producing 00-5 size capsules, with controls and Siemens PLC, 230 volt, 3 phase, serial# 35071, built 2006.

  • Used Fuji Paudal Marumerizer spheronizer, model QJ700, stainless steel construction, with 2.0 mm grooved spheronizing plate with plate lift mechanism, jacketed bowl, side discharge with pneumatically operated plug valve, on base, serial 20050, built 1990.

  • 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.