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

Deliverables

• Stability/transportation protocols with rationales, acceptance criteria and sampling plans
• Chamber mapping records, calibrated instrument certificates and data logs
• Comprehensive validation reports suitable for EU MDR, USFDA 510(k)/PMA submissions

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