Capabilities

pictures_capabilitiesCreoSalus’ companies work synergistically to provide unmatched innovation and the highest quality products and services for the peptide industry. Raw materials, research, engineering and design, manufacturing, and finished drugs and devices comprise CreoSalus’ product and service solutions.

read about our Methodology here…

Certifications

  • ISO 13485 and ISO 9001:2000 certified
  • FDA registered
  • Validations: IQ/OQ/PQ
  • GMP compliant
  • CE Mark capabilities

Engineering Services

  • Solidworks
  • Industrial Design
  • Rapid Prototypes
  • Model Shop
  • Injection Molded Part Design – Mold Filling Analysis
  • Structural Analysis – FEA
  • Fluid Flow Analysis & Design
  • Packaging Design
  • Reliability Engineering
  • Shape Memory Design
  • Surgical Instrument Design
  • Catheter Design & Development
  • Laser Processing Metals & Polymers
  • Intellectual Property
  • Fixture Design

Manufacturing Services

  • Clean Room Manufacturing
    • Molding
    • Extrusion
    • Assembly
  • Device History Record Generation
      • Device Specifications
      • Manufacturing Process Instructions
      • BOMs
      • Lot Control & Traceability
  • Material Procurement & Control
  • Purchasing/Sourcing
  • Receiving and Inspection
  • Inventory Management
  • Material & Product Storage
    • Process Development & Validation
    • Tooling/Fixture Design & Fabrication
    • Equipment IQ/OQ/PQ
    • DOE
    • Protocols/Testing/Reports
  • Sterile Package Design, Process & Testing
    • Tray/Pouch Specifications & Design
    • Tray/Pouch Sealing Validation
    • Package Integrity Testing/Package Conditioning
    • Sterilization Validation, Management, Protocols & Reports
  • Metal fabrication
  • Plastic injection molding
  • Electronics lab
  • Volume production services
  • Short-run production services
  • Logistics

Clean Rooms

  • More than 10,000 square feet of clean rooms
  • Aseptic fill room
  • ISO Class 5 and 7 rooms
  • Clean room assembly
  • Custom cGMP peptide synthesis
  • Lyophilization