Medical device packaging testing is an integral part of ensuring the safety and quality of medical devices. Proper packaging protects the devices inside, maintains their sterility, and reduces the risk of damage or contamination during transport. This article will define medical device packaging testing and how it works so you can understand its importance for the healthcare industry.
What Is Medical Device Packaging Testing?
It is an essential part of the product development and manufacturing process. It ensures that the packaging will provide adequate protection to the medical device during shipping and storage. This type of testing helps manufacturers meet government regulations and industry standards while also helping to protect consumers from potentially defective products. The tests ensure the physical integrity of the packaging and the performance of its components to guarantee safety and quality.
How Does It Work?
Medical device packaging testing helps ensure a product is securely sealed before it reaches the consumer. This sealing helps protect the product and the end user from contamination and product failure. During testing, packages undergo tests of strength, shock, vibration, puncture, and other factors to ensure they can withstand the rigors of shipping and handling.
There are different tests depending on the product and packaging type. For example, you may test packages for pressure decay or seal integrity. In addition, particular temperature and humidity chambers come into play to simulate different climates and conditions. Experienced technicians conduct the entire test procedure in a laboratory setting. Testing results are then carefully reviewed to confirm that the product meets the necessary safety and quality standards before it goes into the market.
Types of Medical Device Packaging Testing
Medical device packaging testing typically involves a variety of tests to evaluate the performance and safety of the packaging materials. The following are the common types of medical device packaging testing and what they entail:
- Visual Inspection Test
This test is frequently the first of many. It doesn’t require any special equipment but simply looking at the packaging and identifying any defects or damages that may be present.
- Peel Strength Test
Peel strength testing is the most common type of medical device packaging testing. It involves peeling back a piece of the medical device packaging to determine its strength and ability to withstand forces that might cause it to break or tear.
- Creep Test
The creep test is a standard life span assurance check performed on packaging to establish if it will hold certain transport conditions. A container sample goes into a machine to receive constant tensile loads. Afterward, precise extensometers measure the time it takes for the package to fail. If the packet fails within an acceptable time frame, it passes the creep test.
- Burst Test
This test measures the strength of the seal between the product and its packaging. The test uses a pressurized chamber to establish how long the packaging can take before bursting or failing when exposed to pressure.
- Bubble Emission Test
This test uses ASTM F2096 standards to determine whether there are any holes in the packaging, which can cause air to leak out of the package and damage the product inside.
- Air Permeability Test
This test measures the air leakage rate to determine the amount of air that passes through the device. This test aims to ensure that the product will not interact with moisture in its environment and become damaged.
Medical device packaging testing is a much-needed process when developing new and updated devices. These tests ensure that all safety measures are in place to cover potential incidents from poor packaging design and material instability. When dealing with such an essential aspect of the healthcare industry, you must partner with a reputable medical device packaging testing provider. For this purpose, consider contacting the experts at Seal-Check to learn how they can help you out.