In pharmaceutical manufacturing, product safety and regulatory compliance depend on absolute confidence in material performance. Every tubing, fitting, bag, filter, and closure used in a GMP environment must meet strict biological, chemical, and physical criteria defined by international standards such as USP and ISO.

As sustainability becomes a greater priority, quality teams need assurance that new materials can meet these same standards without adding risk or requalification work. ecobio™ components are designed from the start to maintain full validation continuity, combining certified sustainability with the same proven compliance trusted by the industry.

Same Material. Same Performance. Same Validation.

ecobio™ components are manufactured from ISCC PLUS certified, mass-balance resins that are chemically identical to their fossil-based equivalents.  Because the polymer structure, manufacturing process, and performance are unchanged, existing validation data remains applicable.  This ensures that sustainability can be introduced into pharmaceutical systems without any compromise to product integrity, safety, or compliance.

Understanding the Standards That Matter

Pharmaceutical manufacturers and their suppliers rely on a set of well-established standards to ensure material safety and performance. ecobio™ components are designed, tested, and documented to align with these same benchmarks.

How Mass Balance Supports Validation Continuity

Unlike bio-based resins, which often require new polymer grades and process reformulation, mass-balance certified resins are drop-in equivalents within the same production infrastructure.  What this means, is:

• The chemical composition and molecular structure remain identical.

• The manufacturing conditions and equipment are unchanged.

• The product validation, certification, and regulatory files remain valid.

Mass balance certification impacts feedstock accounting, not material chemistry, which is why ecobio™ products maintain full alignment with USP and ISO standards.

Documentation You Can Expect

When sourcing ecobio™ components, customers receive the same documentation package used for traditional materials, plus added sustainability transparency.
Typical documentation includes:

• Certificate of Conformance (CoC)

• Validation Summary Report

• ISCC PLUS Certificate and Statement of Attribution (SD)

• Regulatory and Extractables Summary

This ensures your quality and regulatory teams can verify compliance, traceability, and sustainability in a single file.

Why Validation Alignment Matters

In regulated manufacturing, even a small material deviation can lead to weeks of review, testing, and reapproval. By maintaining equivalency at every stage, ecobio™ allows sustainability progress without risking process disruption or requalification.

For QA and validation teams, this means:

• No duplicate validation testing.

• No new master file or material ID creation.

• Simplified change control and documentation updates.

Key Takeaways

• ecobio™ components are made from mass-balance certified resins that are chemically identical to traditional materials.

• Because the material formulation and process remain unchanged, existing USP and ISO validation data apply directly.

• ecobio™ provides full documentation packages for regulatory review and supplier audits.

• Manufacturers can meet sustainability and compliance goals simultaneously with no trade-offs required.