Medical Device – Cold Chain
Cold Chain experts combine their temperature management knowledge with hands-on experience. Medical device products needing temperature management and control throughout the distribution process leverage solutions perfected by the pharmaceutical industry.
Cold Chain Solutions
Determining the right temperature management solution to meet product and distribution requirements, as well as global regulatory requirements, demands expertise and experience in the field.
- 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 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, 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
- Protocols and trials to support globally compliant temperature controlled packaging solutions
- Support for lane qualification and good distribution practices
- Simulated distribution and thermal profile testing of packaging materials and components
- Lane qualification and good distribution practices support