Our packaging tests are primarily geared towards medical products in sterile packaging and take mechanical and climatic stresses into account. Products are exposed to high loads during transportation, handling and storage. In our institute, we simulate the complete transport cycle of your product for you.
Transport simulation
The transport simulation includes a large number of specific tests that check the suitability of packaging for the respective intended use.
Products are often transported to their respective destinations via a long and sometimes complex transportation route. As part of the supply chain, transportation is carried out by truck, plane, rail or ship. During transportation, the products and packaging are exposed to various conditions or hazards, including temperature fluctuations, high relative humidity, vehicle vibrations, low pressure loads or the pressure exerted on a package by the stacked shipping units.
The effects of these stresses must be viewed very critically in the case of sterile medical devices, as the sterility of the medical device must be maintained without restriction during transportation.
Carrying out standardized stress tests, such as compression tests, shocks, vibrations, low-pressure loads and climate zone simulation, on your products in combination with the intended packaging provides you with valuable information about the quality and safety of your packaging.
This protects your product, patient safety and your competitiveness on the market.
With the scientific and technical prerequisites, we have created the basis for carrying out stability tests in accordance with ASTM D4169
We attach great importance to the quality and safety of our simulations and analyses.
The test cycle includes the transport simulation:
- Manual handling, free-fall test: to evaluate stability during handling
- Compression test: to determine the maximum load caused by palletizing and stacking
- Low pressure test (air path): to assess the load at low ambient pressure
- Vibration tester for standardized exposure to vehicle vibration in the air and on land.
Exposure to environmental conditions:
- Climate zone simulation: for exposure to climates that are to be expected during transportation, such as high/low temperatures, high/low humidity or alternating thermal stresses.
Guidelines
- according to ASTM D4169
- ISTA packaging tests
For further information, please contact us at
verpackungspruefung@gfps.de
1. manual handling, free-fall test: to assess stability during handling
The safety and integrity of medical devices during transportation are of crucial importance for the promised quality. An important component of the packaging test is the free-fall test, which simulates the effects of accidental impacts and falls during transportation.
During the free-fall test, the medical devices are embedded in their packaging and dropped from a defined height. This simulates the uncontrolled fall of the package during transportation. The aim is to determine whether the packaging and the medical device it contains can survive the fall undamaged.
The free-fall test allows manufacturers to assess the robustness of their packaging and make adjustments where necessary to ensure that products are safely protected.
By carrying out the free-fall test in accordance with the relevant standards, manufacturers can ensure that their medical devices meet the requirements for transportation protection and that patient safety is guaranteed.
Free fall test in slow motion
2. crush pressure test: to determine the maximum load caused by palletizing and stacking
The integrity of packaging for medical devices plays a crucial role in ensuring product quality and patient safety. An important part of the packaging test is the compression test, which assesses the ability of the packaging to withstand pressure without breaking or failing.
During the compression test, the packaging is compressed with a defined force to simulate the load that can be exerted on it during transportation or storage. The aim is to determine whether the packaging is sufficiently robust to protect the medical devices it contains from damage.
The results of the crush pressure test provide valuable information on how the packaging reacts to different loads and whether adjustments are required to ensure the safety of the products.
Carrying out the compression test in accordance with the applicable standards is an important step in the quality control of packaging for medical devices, which helps to ensure the safety and reliability of the products
Upset pressure test
3. low pressure test (air path): to assess the load at negative pressure
Ensuring that packaging for medical devices is airtight is crucial to prevent contamination from external influences such as air, moisture or harmful substances. An essential part of the packaging test is therefore the low-pressure test for transportation by air, which checks the tightness of the packaging under low pressure.
During the low-pressure test, the medical device packaging is placed in a special vacuum chamber in which a negative pressure is generated. This simulates the low pressure conditions to which the packaging may be exposed during transportation or storage. The aim is to ensure that the packaging remains airtight under these conditions and that no undesirable substances can penetrate.
The results of the low-pressure test provide important information about the airtightness of the packaging and enable manufacturers to identify and rectify any leaks. By complying with the relevant standards for the low-pressure test, manufacturers can ensure that their packaging meets the requirements for product integrity and that the safety of the products is guaranteed.
Low pressure test
4. vibration tester (land, air and sea): to assess the effects of sinusoidal and noise vibrations
Exposure to vibrations during transportation can cause considerable damage to medical devices if the packaging is not sufficiently robust. In order to assess the stability of packaging for medical devices, a vibration test is therefore carried out to simulate the reaction of the packaging to vibrations.
During the vibration test, the medical device packaging is placed on a vibration platform that generates different frequencies and intensities of vibration. The aim is to determine whether the packaging and the products it contains can withstand the vibrations without being damaged or losing their integrity.
The results of the vibration test provide valuable information on how the packaging reacts to the stresses caused by vibrations and whether adjustments need to be made to improve the stability of the packaging.
The vibration test is therefore an important part of the packaging test for medical devices, which helps to ensure the quality and reliability of the products.
Vibration test
5. test for resilience in environmental simulation: climate zone simulation: to evaluate the effects of temperature, wetness and thermal cycling
Ensuring the product integrity of medical devices during transportation requires consideration of various environmental conditions, including temperature and humidity. The climate zone simulation is used to evaluate the reaction of packaging for medical products to these environmental conditions.
During the climate zone simulation, the medical device packaging is placed in a climate chamber that simulates various temperature and humidity conditions to which the packaging may be exposed during transportation. The aim is to determine whether the packaging and the products it contains remain stable and retain their integrity under these conditions.
The results of the climate zone simulation provide important information on how the packaging reacts to different environmental conditions and whether adjustments are required to improve the stability of the packaging.
Climate zone simulation is therefore an indispensable step in the packaging testing of medical products, which helps to ensure the quality, safety and reliability of the products.
Our transport simulations, as well as the possibility of subsequent packaging testing and microbiological testing, enable us to offer you everything from a single source.