Environmental Conditioning, Cycling and Simulation Testing

We employ high-performance Cincinnati Sub-Zero environmental chambers to provide conditioning, accelerated aging and real-time storage programs to pharmaceutical/biotechnology, medical device and consumer product manufacturers.

Our experts perform accelerated aging on materials, products and packaging systems including packaged medical devices to provide a theoretical equivalent to real-time shelf life. Accelerated-aging conditioning, based on the Q₁₀ theory of ASTM F1980, allows you to evaluate your package system performance.

Our series of qualified test chambers helps you evaluate and define shelf life claims in a fraction of the time. We also offer real-time aging programs and storage at typical conditions in one integrated laboratory.

We continually upgrade and expand our state-of-the-art equipment. We offer a variety of core conditions for your testing needs:

• -30°C to +60°C walk-in environmental chamber for larger projects
• +23°C ± 1°C /50% RH ± 2% walk-in environmental chamber for real-time/controlled environment, ASTM and TAPPI
• Reach-in and bench-top chambers with capabilities from -70°C to +190°C for developmental studies
• +5°C ± 3°C ICH refrigerated long-term storage
• +25°C ± 2°C/60% RH ± 5% ICH long-term/accelerated (refrigerated)
• +30°C ± 2°C/65% RH ± 5% ICH intermediate (Zones I, II, III and IVa)
• +30°C ± 2°C/75% RH ± 5% ICH long-term (Zone IVb)
• +40°C ± 2°C/75% RH ± 5% ICH accelerated (Zones I–IV)
• -20°C ± 5°C ICH long-term (frozen)
• -70°C through -90°C cryogenic storage

Our precision CSZ temperature/humidity chambers are fully programmable for profile cycle testing, including:

• Thermal performance of packaging
• Product quality and reliability
• Product life expectancy
• Drug stability protocols
• Forced degradation studies

Thermal cycle testing is important for product and package development to ensure that adverse effects from extremes in climatic conditions do not harm the efficacy of drug products, that packaging protects products from excursions in temperature and humidity and that the packaging itself does not deteriorate under extremes in climatic conditions.

We conduct package and distribution testing in accordance with the following industry guidances:

Pharmaceutical/Drug Stability/Cold Chain Package

• PDA TR #53 Stability Testing to Support Distribution of New Drug Products
• PDA TR #39 Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment
• ICH Q1C Stability Testing for New Dosage Forms
• ISTA Standard 20/7E Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment
• ISTA 7D Temperature Test for Transport Packaging

Medical Device Package

• ASTM D 4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
• ASTM F 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• ASTM F 2825 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
• ISO 11607 Packaging for Terminally Sterilized Medical Devices — Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems