Pharmaceutical Cold Chain Validation & Thermal Package Testing

Maintain Regulatory Compliance and Product Integrity with ISO 17025 Accredited Testing.

In the highly regulated life sciences sector, the “last mile” is often the most critical. GH Testing provides comprehensive thermal packaging validation to ensure your temperature-sensitive products—from biologics to clinical trial materials—maintain efficacy throughout the global distribution chain.

Technical Capabilities & Accredited Standards

We validate packaging systems against rigorous industry benchmarks to ensure they withstand atmospheric extremes and mechanical stresses.

• Thermal Performance Testing: We provide validation for refrigerated, frozen, and Controlled Room Temperature (CRT) profiles.
• ISTA Procedures: Our lab is equipped for accredited testing including ISTA 7D and 7E for thermal performance.
• ASTM Standards: We offer comprehensive testing to various ASTM methods for thermal insulation and package integrity.
• Distribution Simulation: We integrate thermal conditioning with mechanical stress tests, including Vibration, Drop, Shock, Incline/Impact, and Compression.

Environmental Conditioning Profiles

Our lab utilizes calibrated environmental chambers to simulate the exact conditions your product will face. We offer a wide range of standard and custom profiles including:

• Extreme Cold and Severe Cold: Testing down to -20F or 0F.
• Humid Environments: Profiles simulating cold/humid 40 (85% RH) or 100 (85% RH) conditions.
• Extreme Heat: Dry heat simulations up to 140F.
• User-Defined & Cyclic Testing: We execute tailored cycles and atmospheric conditioning based on your specific supply chain requirements.

The Validation Framework: IQ, OQ, PQ

We support packaging engineers through every stage of the validation lifecycle:

1. Installation Qualification (IQ): Ensuring all equipment and environmental chambers are installed and calibrated to NIST-traceable standards.
2. Operational Qualification (OQ): Testing “empty box” or worst-case scenarios to establish the thermal boundaries of your packaging design.
3. Performance Qualification (PQ): Validating the fully loaded system—using your specific product or an approved simulant—to ensure it performs under real-world distribution cycles.

Why Engineers Partner with gh Testing

• Data-Driven Reporting: Receive comprehensive reports including measurement uncertainty to satisfy FDA and global regulatory audits.
• Custom Acceptance Criteria: We test against your specific requirements, whether the goal is a damage-free product or an intact package.
• Failure Analysis & Consultation: Our team provides post-test consultation to help you refine the design if a package fails to meet criteria.
• Visual Documentation: High-definition video and photography of tests are available to document the package’s physical and thermal journey.

Ready to Validate Your Thermal Packaging?

Whether you are testing a new passive thermal shipper or performing a retest due to a material or product change, our team is ready to assist.

Why Choose gh Testing?

• Submission-Ready Data: Detailed reporting, video, and photography to support your regulatory audits. 

• Accredited Accuracy: ISO 17025 accredited testing with measurement uncertainty data available. 

• Expert Consultation: Professional guidance from test start to final report.