Stability and transportation testing ensures that medical devices and combination products maintain their safety, performance and sterility throughout shelf life and distribution. Accuprec provides ICH-aligned stability programs and real-world transit simulations (ASTM / ISTA) to validate packaging systems, sterile barriers and device functionality under environmental and mechanical stresses.

Stability Studies (ICH-Aligned)

• Real-Time & Accelerated Conditions — Temperature/RH profiles (e.g., 25/60, 30/65, 40/75) with programmable chambers.
• Thermal Cycling / Freeze–Thaw — Stress evaluation for materials, seals, drug–device interfaces.
• On-Stability Testing — Functional checks, visual integrity, CCI support, label/IFU endurance.
• Photostability (as applicable) — Light exposure effects on packaging and device materials.
• Protocol & Report — Time-point plans, acceptance criteria, change-control rationale.

Transportation Testing (ASTM / ISTA)

• Vibration Profiles — Random/sine profiles to simulate truck/air/sea logistics.
• Drop & Impact — Free-fall drop, concentrated impact, rotational edge drops.
• Compression — Static and dynamic compression for stacking/warehousing.
• Atmospheric Conditioning — Altitude, thermal/humidity pre-conditioning.
• Data Logging — Temperature, humidity and shock monitoring with traceability.

Packaging Validation & Sterile Barrier Integrity

• ISO 11607 Compliance — Validation of packaging systems and processes.
• Seal Strength & Peel — ASTM F88, burst, dye leak, bubble emission.
• Aging Studies — Real-time/accelerated aging for shelf-life substantiation.
• Post-Distribution Checks — Visual integrity, label durability, traceability/UDI legibility.

Outcome: Regulator-defensible evidence that your product and packaging withstand storage and distribution without loss of safety, sterility or performance.