by Lean Biologix | May 7, 2026 | Supply Chain Testing
In today’s increasingly complex pharmaceutical supply chain, ensuring the authenticity and safety of prescription drugs is more important than ever. The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to strengthen the integrity of the U.S. drug supply...
by Lean Biologix | Apr 21, 2026 | Packaging and Labeling Support, Supply Chain Testing
Selection of Representative Materials for Shipping Qualification Shipping qualification is the rigorous process of proving that a packaging system can protect its contents through the hazards of the supply chain. A critical question arises during this process: Do we...
by Lean Biologix | Mar 19, 2026 | Packaging and Labeling Support, Supply Chain Testing
Dry Ice Effects on CO2 Ingress Dry ice, the solid form of carbon dioxide (CO2), is used in shipping for maintaining low temperatures, such as ≤ -60℃ or ≤ -65℃, due to its sublimation property. As dry ice transitions directly from solid to gas, it releases significant...
by Lean Biologix | Mar 10, 2026 | Packaging and Labeling Support
How EU’s PPWR Impacts US Medical & Biotech Exports For US manufacturers of medical devices, diagnostics, and biotechnology products, the European Union (EU) represents a critical market. However, access to that market now requires navigating the complex new...
by Lean Biologix | Aug 22, 2025 | Supply Chain Testing
What is ASTM D4169 testing? ASTM International developed the standard ASTM D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems,” to test a shipping systems’ ability to withstand typical distribution hazards that occur in a supply...
