SOLID DOSE MANUFACTURING SOLUTIONS

• Pharmaceutical Solid Dose Manufacturing Equipment: Mixing, Blending, Dispensing, Containment

  The pharmaceutical OSD manufacturing sector typically includes the final formulation to produce tablets and capsules, so the need to meet the current Good Manufacturing Practice (cGMP) regulations and quality standards is paramount.

• Integrated Turn-Key Solutions For Aseptic Filling And Containment

  See how aseptic processing, containment, transfer, and integrity testing can be combined into flexible, regulation-ready workflows that improve operator safety and protect product quality.

• Powder Flow Properties & Characterization Services

  Basic Powder Flow Characterization [USP <1174>]:

  A powder flow analysis is an indicator of how well formulation will release from the hopper during the tableting. It is important to know that the developed formulation is showing ‘Mass Flow’ or ‘Funnel Flow’ or ‘Rat Holing’.

  Powder blend shows ‘Mass Flow’ when the entire solid bed is in motion during the discharge of material from the outlet. This is a ‘First-in-First-Out’ process. Hoppers offering ‘Mass Flow’ have steep and/or low-friction walls. This flow offers ‘No-Arching’, ‘Less Segregation’, and ‘Stable Powder Flow’.

  When the hopper is not sufficiently steep and smooth enough to ensure sliding along its wall, the powder blend exhibit ‘Funnel Flow’. Such hoppers are sensitive to arching and ratholing. In this case, powder discharge from the hopper is not predictable.

• 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 Tablet Press Repair and Maintenance

  Each service visit will include the following:

  • Preventative Maintenance
  • Equipment inspection (paddle feeder, tachometer, cams, compression rollers, etc.)
  • Turret inspection
  • Additional Operator and Technician Training

• API Manufacturing And Material Handling Equipment
• Used Freund-Vector Micro Roll Compactor & Granulator: TFC-LAB
• Inhalation Products: Technology And Know-How
• Used 8.5" O'Hara LabCoat BT Pharmaceutical Tablet Coating Pan