Stability Testing

The shelf life or the expiration date of a combination product is determined by the shortest estimated shelf life of the stability testing including drug stability, device aging, and packaging system/ sterile barrier aging. The stability testing provides regulatory agencies with critical information for approval, assure product quality throughout the storage period, provides health care providers with product label instructions for storage period and condition, and provides patients with confidence in the product safety.

STEMart provides a variety of stability testing services to help manufacturer determine the shelf life of their combination product.

Applicable Standards

• ICH Guideline Q1A Q1A(R2) Stability Testing of New Drug Substances and Products
• ICH Guideline Q1B, Photostability Testing for New Drug Substances and Drug Products
• ICH Guideline Q1E Stability Data Evaluation
• ASTM F1980 – 07: Standard Guide for Accelerated Aging Sterile Barrier Systems for Medical Devices, Information for Developing Accelerated Aging Protocols to Determine the Aging Effects on Sterile Barrier System (Packaging)
• AAMI TIR 17 – 08: Compatibility of Materials Subject to Sterilization, Annex G Accelerated Aging Programs, Summary on Accelerated Aging Principles and Use of Fixed and Iterative Aging Methods
• AAMI TIR 22, 2007. Guidance for ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices— Part 1 and Part 2: 2006

Stability Testing Services

• Drug Stability Testing
• Long-term storage at 25 °C/60% RH
• Intermediate storage at 30 °C/65% RH
• Accelerated conditioning storage at 40 °C/75% RH
• Photostability testing: Evaluate the product's ability to withstand exposure to UV / VIS light without any adverse effects.
• Forced degradation studies: Exam degradation products under predetermined stress conditions to assist in establishing degradation pathways and developing and validating stability indicating analytical procedures.
• Temperature cycling studies: Assess the impact of temperature changes on the product.

Typical drug stability testing attributes include:

• Appearance
• Total Drug Content (Assay)
• Drug Degradation Products/Impurities
• Drug Release/Drug Elution/Dissolution (USP) Particulate Matter
• Device Aging
• Sterile Barrier System (SBS) Aging

Test seal strength, impact resistance, seal leaks, etc. at regular intervals according to ASTM guidance.

STEMart provides stability testing of combination product to help manufacturer investigate how the quality of their product varies with time under the influence of different environmental factors such as temperature, humidity and light and establish product shelf life and recommended storage conditions. If you want to learn more detail about our stability testing services, or would like to consult with the experts at STEMart, please feel free to contact us.