It has been observed that packaging is not considered enough in the product development process. Due to which, manufacturers may face serious issues that could have been avoided if addressed earlier. Here, we outline the steps that must be taken while developing a new or revising existing packaging for terminally sterilized medical devices.

Testing of medical device packaging has two major objectives:

1) It ensures the integrity of a sealed package
2) It ensures that the package must not permit leaks to develop during sterilization, normal handling, transportation, and storage.

Testing assures a package's ability to provide and maintain a sterile barrier around a medical device.
According to ISO 11607-1997, Packaging for Terminally Sterilized Medical Devices, the seal-strength testing and package integrity testing both are required to precisely analyse a package's design and record its conformance to specifications. In this article, we will focus on seal-strength testing methods.
Seal-strength testing checks the mechanical strength of the seal, ensuring strong material bonding to maintain package integrity throughout its life. One of the seal-strength test methods majorly applied in medical industries is burst strength testing.

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Burst Strength Testing Method

Bursting test is a peak inflation pressure test. A package is inflated under a uniform pressure and flow rate until the seal burst open at its weakest point.

This test does not require any sample preparation, and it can be performed with little operation training. However, the resulted burst pressures may vary as per the package characteristics. Packaging size will also influence the results; burst values for a large sample will be less than those of a smaller sample.

We bring you a highly advanced and standardized Bursting Strength Testing equipment which can help you ensure high-quality packaging experience.

Bursting Strength tester

Key features:

• Easy to operate, highly advance digitalized model with feather touch control
• Generates accurate, consistent, repeatable and reliable data
• Equipped with Peak & TARE facility
• Calibration facility is available
• Single Push Button Operation
• Microprocessor based display for accurate test
• Memory to hold up to 9 tests
• Highly accurate test results under multidirectional Force
• Strong Gripping clamps
• Grooved structure of Test Specimen Holder to avoid slippage and intact holding of specimen under test
• No slippage in case specimen is tightened uniformly using operating wheel

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