Pharmalucence formally CIS-US Inc.
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Capabilities and Specifications
Aseptic Filling
Lyophilization




Capabilities and Specifications

Pharmalucence CMO Capabilities and Specifications

 

Please Note: Upon our aquisition by Sun Pharma in July 2014, we no longer perform CMO services for external third parties.

Best in Class Technology combined with Solid Leadership and Experience

  • Over twenty years of parenteral manufacturing experience as a fully integrated pharmaceutical company
  • CMC experts
  • Currently manufacture and release over 40 lots of commercial products annually

Development Expertise

  • Formulation Development
    • Lyophilized
    • Liquid
  • Process Validation
  • Technical Transfer
  • Analytical Method Development and Validation
  • Impurity Identification
  • Stability Services
  • Global Regulatory Support
  • Packaging Development

Manufacturing Expertise

Non-cytotoxic, non-high potency products only
  • Fully isolated filling line from vial preparation to ISO 5 RABS capping station
  • Multiple product capability
  • Clinical to commercial scale
  • Aseptic process
  • Terminal sterilization
  • Liquid Fill: up to 120 vials/minute
  • Lyophilized Fill: 180 sq. ft. capacity (x2)
  • Automated CIP/SIP
  • Automated vial load/unload
  • Vial sizes from 2 ml to 100 ml
  • 100% fill check (by weight)

 


29 Dunham Road, Billerica, MA 01821 | Telephone: 781-275-7120    © Pharmalucence Inc. All rights reserved.
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