Glossary Term
Package Integrity Testing
Definition
Package Integrity Testing is a process used to assess the seal and strength of packaging used for medical devices and pharmaceuticals. The goal of this testing is to ensure that the packaging maintains its protective qualities, such as sterility, containment, and safety, throughout the product's lifecycle, from manufacturing through distribution and storage to end-use. This testing verifies that the packaging is secure and capable of protecting the product from contamination, degradation, or damage.
Relevance to the MedTech Industry
Package integrity is critical to ensuring that medical devices, particularly sterile products, remain safe and effective until use. Effective package integrity testing ensures that devices are not compromised during storage or transport, maintaining compliance with regulatory standards such as ISO 11607 (sterile barrier systems for medical devices) and ensuring patient safety.
Additional Information & Related Terms
Key Components of Package Integrity Testing
Seal Strength Testing:
Measures the strength of the seal between two components of the package (e.g., lid and base) to ensure it remains intact under stress.
Example: Testing the seal strength of sterile medical device packaging to prevent leaks or contamination.
Vacuum or Pressure Decay Testing:
Assesses the packaging's ability to maintain a vacuum or pressure, ensuring that it does not allow the ingress of air or microbes.
Example: Testing the vacuum seal of a sterile packaging system used for surgical instruments.
Bubble Emission Testing:
A test used to detect leaks in sealed packaging by submerging the package in water and observing whether bubbles are emitted.
Example: Checking a medical device packaging for micro-leaks that could compromise sterility.
Seal Peel Testing:
Involves peeling open the package to ensure that the seal is intact and that the opening process does not damage the product.
Example: Ensuring that a sterile barrier system can be opened easily without compromising the product’s integrity.
Thermal Testing:
Determines how the packaging performs under various temperature extremes to simulate storage and transportation conditions.
Example: Testing packaging materials of vaccines to ensure that they maintain integrity during transportation in extreme temperatures.
Related Terms
Sterility Assurance: Package integrity testing is a critical part of sterility assurance, ensuring that medical devices and products remain sterile and safe for use.
ISO 11607: A set of standards that defines the requirements for packaging used in the medical device industry, ensuring sterility and product safety.
Quality Control (QC): Package integrity testing is an integral part of quality control, ensuring that packaging defects are detected before products reach customers.
Packaging Validation: Validation ensures that packaging processes meet all regulatory and quality standards. It overlaps with package integrity testing to confirm that packaging methods are effective.
Barrier Systems: These systems, which include packaging materials that protect sterile products, are critical in maintaining package integrity, especially in devices like surgical tools or implants.