Robust packaging ensures product integrity, sterility maintenance, traceability and patient safety throughout shelf life and distribution. Accuprec validates packaging systems and evaluates mechanical performance to meet ISO 11607 and global regulatory expectations for medical devices and combination products.

Sterile Barrier System Validation (ISO 11607)

• Process Validation: Form–fill–seal parameters, sealing temperature/pressure/time windows, reproducibility.
• Seal Quality & Integrity: ASTM F88 (seal strength), burst testing, peel testing, dye penetration, bubble emission.
• Aging Studies: Real-time & accelerated aging for shelf-life substantiation and package durability.
• Label/IFU Endurance: Print legibility, adhesion, barcode/UDI readability post-aging and transit.

Mechanical & Durability Testing

• Tensile / Compression / Flexural: Material strength, crush resistance, stacking integrity.
• Puncture & Tear Resistance: Film and pouch toughness against sharps and handling.
• Drop & Impact: Corner/edge/face drops, rotational impacts for packaged devices.
• Environmental Conditioning: Temperature/humidity cycling, freeze–thaw, altitude simulation.

Transportation Simulation (ASTM / ISTA)

• Vibration Profiles: Random/sine spectra to emulate road/air/sea logistics.
• Shock & Compression: Handling abuse, stacking and warehousing conditions.
• Post-Transit Checks: Visual integrity, seal strength, sterile barrier maintenance and label durability.

Documentation & Deliverables

• Validation protocols (rationales, acceptance criteria, sampling plans).
• Calibrated equipment records, chamber mapping and data logs.
• Comprehensive reports aligned to EU MDR / USFDA 510(k)/PMA submissions.

Outcome: Regulator-defensible evidence that packaging and device assemblies maintain sterility, identity and performance from manufacture to point of use.