ENVIRONMENTAL CYCLING AND SIMULATION TESTING

Whitehouse Labs operates and array of precision Cincinnati Subzero (CSZ) temperature/humidity chambers and data acquisition equipment.  These high quality and reliable chambers are fully programmable for profile cycle testing including…

  • Thermal performance of packaging
  • Product quality and reliability
  • Product life expectancy
  • Drug Stability protocols  

Thermal cycle testing is important for product and package development in order to ensure that adverse affects from extremes in climatic conditions do not harm the efficacy of drug products; packaging protects products from excursions in temperature and humidity; and packaging itself does not deteriorate under extremes in climatic conditions (e.g. dry desert, tropical, etc.).

For example; chambers are used specifically for cold chain packaging to validate they are performing as intended and designed for shipping drug products.  Accelerated aging protocols are performed in the CSZ chambers to confer shelf life claims to medical devices. Capabilities are shown below:

 

Climatic Description

Temperature Range

Walkin Environmental Chambers for Larger Projects

30°C to +60°C +23°C ± 1°C /50% RH ± 2%

Reach in and Bench Top Chambers for developmental studies

-70°C to +190°C

ICH Refrigerated Long-Term Storage 

+5°C ± 3°C

ICH Long-Term/Accelerated (Refrigerated

+25°C ± 2°C /60% RH ± 5%

ICH Intermediate (Zones I, II, III and IVa)

+30°C ± 2°C /65% RH ± 5%

ICH Long Term (Zone IVb)

+30°C ± 2°C /75% RH ± 5%

ICH Accelerated (Zones I-IV)

+40°C ± 2°C /75% RH ± 5%

Long-Term (Frozen)

-20°C ± 5°C ICH

Cryogenic Storage

-70°C through -90°C

 

DISTRIBUTION AND PACKAGE TESTING

  • ASTM & ISTA Distribution Testing
  • Pharmacuetical Package Testing
  • Consumer Product Testing
  • Shelf Life & Accelerated Aging Testing
  • Environmental Conditioning
  • Packaging Materials Testing
  • Package Integrity Testing
  • Package Strength Testing
  • Package Labeling
  • Environmental Testing

 

INDUSTRIES SERVED

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

Whitehouse Laboratories is happy to assist customers to better understand the testing requirements, the available test options and how to execute packaging validation projects on time and on budget. Have a question about Package Testing?

Contact Us or call 908-823-9336 about your next testing project.