Integrity Testing

(Download: Integrity Testing in PDF by Medistri)

Integrity testing (also known as Sterile Barrier Integrity Testing) is a critical quality control measure used to ensure the integrity, or the ability of a package to contain and protect its contents. Integrity testing is used to detect any leaks, punctures, or other defects that can compromise the packaging and potentially lead to contamination or spoilage of the contents.

Integrity testing is a critical step in validating the quality and safety of packaging materials and ensuring that they meet regulatory requirements. There are several methods used for integrity testing, including visual inspection, dye penetration, bubble emission testing, vacuum decay testing, and pressure decay testing. Each method has its own advantages and limitations, and the choice of method depends on the nature of the package and the contents.

Integrity testing is important for several reasons:

✔ Product safety: Integrity testing ensures that the package is capable of maintaining the integrity of its contents, preventing contamination or spoilage of the product. This is especially critical medical devices or pharmaceuticals products.

✔ Regulatory compliance: Regulatory agencies require that packaging materials meet specific standards, and integrity testing is often required to demonstrate compliance. Failing to meet these standards can result in regulatory action or product recalls.

✔ Quality control: Integrity testing is an important part of a comprehensive quality control program, helping to identify any defects or issues with the packaging materials before they are used to package products.

✔ Cost savings: Detecting defects or leaks early in the production process can help to prevent costly product recalls and production delays.

👉 Overall, integrity testing is essential for ensuring the safety and efficacy of packaged products and for maintaining the quality of packaging materials.

At Medistri, we have a complete range of tests to ensure the integrity of your package:

  • Accelerated Ageing Tests, according to ASTMF1908.
  • Real-Time Ageing Tests, according to ISO 11607-1.
  • Visual Inspection Tests, according to ASTMF1886.
  • Dye Migration Tests, according to ASTM F1929 & F3039.
  • Bubble Emission Tests, according to ASTM F2096.
  • Seal Tensile Strength Test, according to ASTM F88.
  • Peel Strength Test, according to EN 868-5.
  • Burst Test, according to ISO2758.

Sterile barrier systems need to ensure the sterility of their contents until opened for use and ensure aseptic presentation.
The sterile barrier system (depending on conditions of handling, distribution or storage) may provide adequate protection for the sterile medical device. In circumstances where the packaged and sterilized device undergoes repeated handling, additional protective packaging may need to be combined with the sterile barrier system to create a packaging system.

Each establishment should evaluate the performance of each sterile barrier system or packaging system before selection and implementation to ensure conditions for sterilization, storage, and handling can be met. Each establishment that manages sterile items should have a documented plan of education on how to store, handle and transport sterile items.

👉 ISO 11607-1 specifies the requirements for materials, sterile barrier systems and packaging systems, including the qualification of the packaging system design and evaluation of that design;

👉 ISO 11607-2 specifies the requirements for packaging process validation. Both of these documents provide standards to ensure medical device protection, the ability to sterilize, maintenance of sterile package integrity and aseptic presentation.

Integrity testing is an important process that helps to ensure that a system or product is working as it should be. By testing for integrity, it is possible to identify any issues or defects that could potentially impact the performance or reliability of the system in the future. Overall, integrity testing should be considered an essential part of any quality assurance process, and should be conducted on a regular basis to ensure ongoing success and effectiveness.

Should you fully validate your packaging system or should you simply test one particular characteristic of your packaging, Medistri laboratory is accredited and highly experienced for the most common tests methods provided by the regulatory agencies.

🎯 To learn more about Medistri’s Integrity Testing services, visit on our website at or directly contact our team at

- The Medistri Team