Packaging Integrity Testing

Medical and pharmaceutical packaging integrity testing to ISO 11607 and USP <1207>.

Packaging Integrity Testing for Medical & Sterile Packaging

In medical device and pharmaceutical manufacturing, packaging integrity testing is non-negotiable. With terminally sterilized products, a failed seal isn’t just a bad batch — it is a direct threat to patient safety and regulatory compliance. Proving that your sterile barrier holds requires a technically defensible, quantitative quality-control cycle.

Optimeasure supports packaging integrity programmes with the UK-made Optiburst platform, which brings an economic, distributed burst and seal-strength testing capability directly to the cleanroom or production floor. Operators can pull products straight from the line and verify structural and seal strength within seconds. Full specifications are on the Optiburst product page.

Regulatory Compliance & Standards

Meeting the expectations of auditing bodies means aligning with global consensus standards:

ISO 11607 (Parts 1 & 2) — mandates a validated process-control system for terminally sterilized medical device packaging. Burst testing (ASTM F1140, ASTM F88) proves seals withstand the internal pressure fluctuations of Gamma or Ethylene Oxide (ETO) sterilization cycles.
USP <1207> — emphasises quantitative, deterministic package integrity testing. Where vacuum decay handles non-destructive micro-leak testing, burst testing is the foundational stress test that maps a package’s physical limits before container closure integrity testing (CCIT).

Burst & Seal-Strength Methods

▶ ASTM F1140 vs ASTM F2054 — how they differ

Method	Objective	Why it matters
ASTM F1140 — Unrestrained	Open-air “stress test” that inflates the pouch until it ruptures	Identifies the absolute weakest point; defines the maximum safe pressure for downstream leak/decay tests
ASTM F2054 — Restrained	Package locked between rigid plates during pressurisation	Limits material stretch so pressure acts on the seal line — a highly repeatable measure of true seal-bond strength

Typical Medical & Pharmaceutical Applications

▶ View medical & pharmaceutical applications

Category	Applications tested
Flexible medical products	Catheters & medical tubing (lumen and bonded-joint pressure thresholds); IV & drainage bags (fluid-retention boundaries)
Sterile medical packaging	Sterile pouches & Tyvek® trays (perimeter seal validation); foil packs & high-risk implant laminates (barrier seal strength)

Engineered for Validated Environments

Three test modes — Burst (peak blowout), Creep (sustained pressure) and Creep to Failure for operational qualification (OQ) data.
Audit-ready accuracy — direct-acting solenoid valves and pressure sensing with <1 mbar accuracy and <0.5% of span linearity.
Hermetic needle seal — foam sealing spots ensure all pressure data reflects the actual status of the package.

Looking for the burst method and equipment overview? See burst testing, or view the Optiburst product page.

Discuss a Packaging Integrity Programme »

Frequently Asked Questions

What standards govern medical packaging integrity testing?

The primary standards are ISO 11607 Parts 1 & 2 (validated packaging for terminally sterilized devices) and USP <1207> (package integrity for pharmaceutical containers). Burst methods ASTM F1140 and ASTM F2054, plus seal-strength ASTM F88, are used within these frameworks.

Is burst testing destructive?

Yes — burst testing is a destructive stress test that inflates the package until it fails, mapping its physical limits. It's typically paired with non-destructive leak methods such as vacuum decay for a complete package integrity programme.

Can the Optiburst support ISO 11607 validation?

Yes. With Burst, Creep and Creep-to-Failure modes, <1 mbar accuracy and audit-ready data output, the Optiburst provides the quantitative seal-strength evidence required within an ISO 11607 validated process-control system.