Medical Devices and Pharmaceutical Testing
QRA is the preferred laboratory services partner for many multinational companies in the medical devices and high technology industries to carry out test for their products and devices.
Our Lab is running 24 hours 7 days a week to carried out testing for our clients in the highest standards according to the latest International Standards.
Accelerated Ageing testing
Accelerated Aging tests are commonly used to demonstrate that a product (including materials, coatings, packaging, and labelling) can be stored for an extended period of time and still function properly.
To accelerate the effects of time, the product is subjected to harsher temperature and humidity conditions than it would normally encounter during its shipping, storage, and operational life cycle.
The objective is to provide confidence that the product will meet its expected lifetime and reliability goals without having to wait an entire life cycle for results.
Common Accelerated Aging Tests:
ASTM F1980: Accelerated Aging of Sterile Barrier Systems for Medical Devices
Typical variables for accelerated ageing test
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Testing temperature: Typically between +50°C and +60°C, most commonly +55°C.
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Ambient storage temperature: Generally between +20°C and +25°C. +20°C will generate the shortest test duration due to the largest temperature delta
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Conservative Q10: Typically 2 for medical devices.
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Relative Humidity: RH is not a factor in the Arrhenius equation. Relative humidity is typically recorded, but not controlled.
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Testing duration: Expiry dates for medical products are typically based on manufacturing date. Some manufacturers add an extra month to the aging study to allow for sterilization and distribution. For example, a 12-month shelf life is simulated based on a 13-month study.
Medical Device Performance and Safety Testing
Our performance and safety testing is designed to accommodate your needs for both healthcare products and laboratory equipment. Our global facilities allow us to provide efficient and custom solutions tailored to your product or facility’s requirements. Our experts understand the changing market and how to best serve your business’ specific needs.
We can help you with:
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Standards testing to help you bring compliant products to market quickly.
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Customized on-site support and training
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Convenient, localized testing in global facilities for electromagnetic compatibility (EMC), software validation and wireless security
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Clearance of FDA 510(k) submissions for devices
Medical Device Packaging Testing
Validation of packaging procedures, such as the forming and sealing of sterile barrier systems, as per ISO 11607-2 is one of our services. Sterilized and final-packed test devices are subjected to both thermal and regular ageing, as well as transport simulation, as part of a combined stability and packaging validation study, according to ISTA or ASTM standards.
The specific qualities of medical equipment and their packaging systems must remain stable during their shelf life, according to ISO 11607-1. Following that, products can be put through a series of testing to determine the packaging system's performance, aseptic presentation, and microbiological barrier qualities, as well as the performance of the enclosed medical device, functionality, and biocompatibility.
The following test systems may be applicable for the packaging system:
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Dye test for seal integrity
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Peel test, burst test and bubble test
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Air permeability test and test for microbiological tightness
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Qualification of packaging materials
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Validation of the forming, sealing, and assembly processes of packaging for terminally sterilized medical devices
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Validation of final packaging systems for sterile medical devices
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Evaluation of the shelf life of the sterile packed medical device
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Stressed medical devices are subjected to specific performance tests as well as to a biological evaluation test strategy