Our design verification test service group is given below. For the requested tests, please fill out the test request form and send it to our e-mail address.
Stability
Medical devices are analyzed to determine the physical effects on the sterile barrier system under aging conditions. The information obtained after aging procedures determines the expiration date of medical device sterile barrier systems.
The products are stored under specified temperatures and humidity in accordance with ASTM F1980 standard, taking into account the physical and chemical properties of the products. It is important to determine the samples taken with a statistical justification to show that stability studies cover all products manufactured.
At the same time, a stability protocol for non-sterile products can be prepared by our experts, taking into account the nature of the product.
Click for test request form.
Packaging Integrity Tests
Packaging designs must have a microbiological barrier to maintain the sterility of a packaged product until use. Medical device manufacturers must prove that the packaging integrity of their products is unaffected by transportation validation, accelerated aging, real-time aging and to the point of specified shelf life.
Testing package integrity is essential for assessing the sterility and shelf life of a medical equipment or product. Package integrity testing includes tests such as visual, tensile, burst, sealing width as specified in the EN ISO 11607 standard series.
First of all, the relevant test request form is requested. According to the request form, tests are carried out and reported by our laboratory experts. The test report is shared with the customer. Our scope of service is as follows:
Packaging integrity tests
- Tensile Strength Test (ASTM F88- EN 868-5)
- Visual Test (ASTM F1886)
- Burst Test (ASTM F1140-ASTM F2054)
- Seal Width Test (EN 868-5)
- Leakage Test (ASTM F1929)
Transport Simulation Tests
Transport studies provide a consistent framework for assessing the resistance of products to the distribution environment in the laboratory. This is performed by putting products through a test plan that includes a series of estimated hazards experienced during different distribution cycles. Together with the test plan, a protocol is drawn up, taking into account the manufacturer's distribution route. Tests are performed in accordance with the protocol and appropriate reporting is done.
ASTM D4169-22 standard is followed when preparing the test plan.
Service scope:
- Transport protocol and report
- Environmental conditioning chamber
- Vibration
- Drop
- Compression
- Vacuum (for airway)
Click for test request form.
You can also visit our sister company NioReg.
