Temperature-Controlled Vibration with Pressure Testing for Drug Product Stability

Real-world simulation for sensitive pharmaceutical products

Smithers provides advanced temperature-controlled vibration with pressure testing to assess the stability of pharmaceutical drug products and active ingredients during distribution.

This service replicates the combined stresses of temperature variation, vibration, and reduced pressure to evaluate how products perform under true-to-life cold-chain and air-freight conditions.

Why simulate vibration with temperature and pressure?

During global shipment, drug products are exposed to vibration, temperature fluctuation, and low-pressure environments - particularly during air transport.

For many active pharmaceutical ingredients (APIs) and biologic formulations, these factors can interact in complex ways that affect stability, efficacy, or appearance.

‘Real-world’, non-time-compressed simulations combining temperature, vibration and pressure can be used to better understand these environmental impacts and generate meaningful data for API and formulation stability.

Supporting drug stability and formulation studies

Smithers’ temperature-controlled vibration with pressure testing supports:

• Stability and formulation studies for APIs and biologics
• Validation of drug product integrity during cold-chain or air transport
• Investigation of field performance issues
• Route-specific shipment simulations

Our capabilities

Smithers combines precise vibration control with programmable temperature and pressure environments to create authentic, repeatable shipment profiles.

Test configuration includes:

• Temperature range: -10°C to +35°C
• Pressure control: simulation up to 40,000 ft altitude
• Single-axis vibration control for road, air, or sea transit
• Programmable real-world (non-accelerated) vibration profiles
• Capacity for single vials, syringes, carton and shipper boxes

Trusted partner in pharmaceutical shipment studies

Smithers works with leading pharmaceutical and biotech organisations to design tailored transit simulations that reflect true distribution environments. Our ISO 17025-accredited and ISTA-certified laboratories deliver reliable, reproducible data to support development, risk assessment, and regulatory submissions.

Partner with Smithers

Whether validating product stability or exploring the impact of distribution conditions on sensitive APIs, Smithers provides scientific insight, regulatory confidence, and expert guidance.

For packaging validation under combined vibration and temperature stresses, see our Temperature-Controlled Vibration Testing for Healthcare Packaging.

Contact an expert or request a quote to discuss your testing requirements.