Cold Chain

Pharmaceutical – Cold Chain

Cold Chain experts combine their technical knowledge with years of hands-on experience.  This combination provides clients the desired temperature management outcome and often a cost savings.

Cold Chain Solutions

Unbiased assessment and evaluation of various solution provider’s product offerings

  • Unbiased assessment and evaluation of various solution provider’s product offerings.
  • Investigation of active and passive thermal designs to meet design and user requirements, including temperature monitoring
  • Passive & active thermal protection system development and qualification
  • Ambient temperature profile development
  • Legacy packaging systems consolidation and improvement

Quality Systems Documentation

Appropriate documentation supports critical components of temperature management efforts.

  • Gap analysis of current systems with business and user requirements
  • Creation and review of thermal qualification protocols and reports, including acceptance criteria
  • Technical justification to support systems and company and global regulatory requirements
  • Quality systems documentation development and/or support

Good distribution practices (GDP) support

Completing the end-to-end cold chain process through suppliers and supply chain partners

  • Shipping lane qualifications
  • 3PL assessment and auditing
  • Development of quality and supply agreements with supply chain partners
  • E-pedigree and serialization support

Testing & Validation Services

Experts use their unique knowledge of temperature controlled testing to demonstrate cold chain effectiveness.

  • Consulting for selection or development of appropriate thermal profile challenges
  • Execution of validation testing, trials and protocols for temperature controlled packaging solutions to achieve global compliance
    • Includes simulated distribution and thermal profile testing of packaging materials and components
  • Support for lane qualification and good distribution practices