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Cirrus Pharmaceuticals, Inc.
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Services

 

 
Overview
Formulation Development
Analytical Services
Characterization
Extractables & Leachables Services
Particle Size Analysis
Peptides and Proteins
Nanotechnology
Stability Testing
Device Evaluation
Process Development
Regulatory Submission
Manufacturing Oversight and Batch Release
   
info@cirruspharm.com

PROCESS DEVELOPMENT

Our formulation scientists and process engineers collaborate to develop a manufacturing process that can be optimized for robustness and efficiency, then scaled-up through careful evaluation of manufacturing parameters. Elements of the process may include:

  • Blending/homogenization
  • Filtration
  • Filling
  • Container/closure selection
  • Terminal sterilization (heat, filtration)
  • Lyophilization

For MDIs, HFA-134a and HFA-227 are the industry standards and equipment is available in house to execute a variety of cold filling and one- or two-stage pressure filling techniques.

Blending equipment is available for blend process development of dry powder formulations.

Novel process development is also available. Some processes have been patented for clients, with the client being the sole owner of the patent.

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