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Selection of Representative Materials for Shipping Qualification

Selection of Representative Materials for Shipping Qualification

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...
Dry Ice Effects on CO2 Ingress

Dry Ice Effects on CO2 Ingress

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...
PPWR Impact on US Medical & Biotech Exports

PPWR Impact on US Medical & Biotech Exports

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...
Clinical Drug Packaging and Labeling Operation

Clinical Drug Packaging and Labeling Operation

by Lean Biologix | Jul 27, 2022 | Packaging and Labeling Support

The world leader in neurological therapies initiated a plan to bring their clinical packaging from a CMO to an in-house operation. The plan required tripling the current operational capacity. Summary of Engagement Lean Biologix instituted several process improvement...
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  • Selection of Representative Materials for Shipping Qualification
  • Dry Ice Effects on CO2 Ingress
  • PPWR Impact on US Medical & Biotech Exports
  • Comparing ASTM D4169-22 to ASTM D4169-23e1
  • Navigating the Gauntlet: ASTM D4169 vs. ISTA Distribution Tests

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  • Home
  • About
  • Services
    • Supply Chain Testing Services
      • Design Qualification
      • Operational Qualification
      • Performance Qualification
    • Packaging and Labeling Support
    • GxP Computer Systems Validation Services
      • Automated Computer Software Assurance
      • Optimal synTQ Consulting
      • HxGN EAM Consulting
      • SaaS Migration Consulting
      • GxP System Periodic Review
      • Data Science
      • Tibco Statistica
    • Distribution Quality
    • Facility and Asset Management
    • GMP Staff Augmentation
    • Process Improvement
    • Project Management
  • Projects
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    • IT Business Analyst
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GxP Computer Systems Validation
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