Real-world shipment simulation for regulated healthcare products
Smithers provides advanced temperature-controlled vibration testing for medical device and pharmaceutical packaging.This testing accurately replicates the mechanical and thermal stresses experienced during cold-chain transport - helping you verify that packaging systems maintain integrity, sterility, and product protection throughout shipment.
Why combine vibration and temperature testing?
During global distribution, healthcare products face vibration from road, air, and rail transport, while moving between refrigerated or frozen environments. These combined stresses can cause:- Seal and closure failures
- Material brittleness at low temperatures
- Movement or abrasion of components
- Compromised sterile barriers
Testing designed for these packaging challenges
Smithers supports packaging validation and development for:- Medical devices and sterile barrier systems
- Pharmaceuticals and biologics
- Temperature-sensitive and cold-chain products
- Combination products and clinical trial shipments
Our capabilities
Smithers’ environmental vibration systems simulate real-world cold-chain shipment profiles.Test configuration includes:
- Temperature range: -10°C to +35°C
- Single-axis vibration control for road, sea, or air distribution
- Capacity for single packages or full pallets
- Programmable vibration profiles to replicate specific transport routes
- Testing to ISO 11607, ASTM D4169, and ISTA procedures
Our laboratories provide controlled, repeatable data to support packaging validation, troubleshooting, and regulatory submissions.
Compliance and confidence
Smithers’ laboratories are ISO 17025 accredited and ISTA certified, ensuring reliable, defensible data to support:- Regulatory submissions (FDA, MHRA, EMA)
- Design validation and verification under ISO 11607
- Package performance troubleshooting in transit studies
Partner with Smithers
Our experts work with you to define the right test plan, interpret data, and recommend next steps. With facilities in the UK and US, Smithers delivers trusted insight and reproducible results for healthcare packaging.For studies focused on drug product stability under combined temperature, vibration, and pressure, explore our Temperature-Controlled Vibration with Pressure Testing service.
Contact an expert or request a quote to discuss your medical and pharmaceutical packaging challenges.
- ISO 11607 Testing | Healthcare Packaging Validation
- Shelf Life Studies
- Medical and Pharmaceutical Shipment Studies
- Sterile Barrier System Integrity Testing
- Tamper-Evident Packaging Testing
- Temperature-Controlled Vibration Testing for Healthcare Packaging
- Temperature-Controlled Vibration with Pressure Testing for Drug Product Stability
Contact an expert