ISO 10993 Biocompatibility Testing Compliance for Packaging Materials
The ISO 10993 series of standards is a comprehensive set of guidelines designed to ensure that medical devices, including those in pharmaceutical packaging materials, are safe and do not cause adverse effects when used as intended. This service focuses on providing compliance testing for packaging materials with the biocompatibility requirements outlined by ISO 10993-18:2017. Our team of experts ensures that your packaging materials meet all necessary criteria to pass regulatory inspections.
The process begins with a detailed review of your product specifications and intended use, followed by the selection of appropriate test parameters based on the material composition and expected application. We then carry out rigorous testing in our state-of-the-art laboratories using cutting-edge equipment and methodologies compliant with ISO 10993 standards.
Our services include:
- Biocompatibility testing according to ISO 10993-18:2017
- Skin patch test (ISO 10993-11)
- Systemic toxicity tests (ISO 10993-4)
- In vitro cytotoxicity testing (ISO 10993-5)
- Subchronic toxicity studies
The testing process involves the use of various specimens, including extracts from your packaging materials. These are subjected to a series of tests designed to identify potential adverse effects on human health.
We also provide detailed reports that outline all test results and conclusions drawn from them. Compliance with ISO 10993-18 ensures that your packaging meets the biocompatibility requirements set forth by regulatory bodies such as the US FDA, EU EMA, and others.
By choosing our service, you ensure that your pharmaceutical packaging materials are not only safe but also compliant with international standards. This can help avoid costly delays in product launches and potential legal issues down the line.
| Applied Standards | Description |
|---|---|
| ISO 10993-18:2017 | Biocompatibility evaluation of medical devices for use in contact with blood. |
| ISO 10993-5:2018 | In vitro cytotoxicity testing of medical devices. |
Applied Standards
| Standard | Description |
|---|---|
| ISO 10993-5:2018 | In vitro cytotoxicity testing of medical devices. |
| ISO 10993-4:2016 | Systemic toxicity tests for medical devices. |
Industry Applications
| Application | Description |
|---|---|
| Pharmaceutical packaging materials compliance testing | Ensuring that the materials used in pharmaceutical packaging do not cause adverse effects when exposed to human tissue or fluids. |
| Biocompatibility evaluation for medical devices | Evaluating the safety of medical devices that come into contact with blood and other bodily fluids. |
Customer Impact and Satisfaction
- Simplified compliance: We handle all aspects of ISO 10993-18 testing, ensuring your packaging meets regulatory requirements.
- Rapid turnaround times: Our streamlined processes ensure that you receive timely results without compromising on quality.
- Cost-effective solutions: By avoiding costly delays and potential legal issues, our service offers significant cost savings for your business.
