Medical Device Package Seal Validation & Integrity Testing

Medical packaging can lose its integrity as a result of dynamic events that occur during processing and/or distribution.  Because of this, QTS employs physical test methods that validate the package integrity has been maintained throughout all the phases of processing, handling and expected shelf life. If your project is particular, QTS will develop custom validation protocols to meet your specific quality requirements.

Package Validations for Sterilized Medical Devices

QTS adheres to ISO standard 11607, “Packaging for Terminally Sterilized Medical Devices,” an international standard that specifies the requirements for single-use materials and re-usable containers for packaging of terminally sterilized medical devices.

QTS completes rigorous package and seal validations to ensure every package meets the requirements to protect medical devices by complying with ISO and ASTM standards.

Validation Services

• Seal Validation Protocol Development
• Package Integrity Testing
  • Dye Penetration (ASTM F1929)
  • Bubble Leak (ASTM F2096)
  • Visual Inspection (ASTM F1886)
• Seal Strength Testing
  • Tensile Testing (ASTM F88)
  • Burst Testing (ASTM F2054)
• Shelf Life Studies and Accelerated Aging (ASTM F1980)
• Transportation and Distribution Testing (ASTM D4169, ISTA1, 2 & 3 series)
• Sterilization Validations
  • Ethylene Oxide, Gamma irradiation, Steam, Electron Beam irradiation
  • Protocol Development
  • Sample Preparation
  • Analytical Testing
  • Reports
• Cleaning Validations

Establishing Product Families

Product families are often established so that a representative product can be chosen to represent an entire product family for validation purposes. This can considerably reduce the costs associated with a validation.

The experienced packaging engineers and microbiologists on staff at QTS can assist in establishing product families for validation and routine monitoring purposes. By establishing product families, QTS can help minimize testing costs. We’ll help you through the process of justifying product family groupings, as well as selecting product family representatives.  Product families can be established for:

• Packaging validations
• Cleaning validations
• Radiation sterilization dose setting
• Ethylene oxide sterilization validations