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