ISO 10993 Cytotoxicity Screening Support for Ophthalmic Contact Packaging
The ISO 10993 cytotoxicity test is a critical component of the regulatory compliance process in the pharmaceutical industry, especially for products that come into direct contact with ocular tissues. This service focuses on providing support and expertise to pharmaceutical companies during the cytotoxicity screening phase specifically related to ophthalmic contact packaging.
The primary goal of this testing is to ensure the safety of materials used in packaging ophthalmic products by assessing their potential for causing adverse reactions when exposed to ocular tissues. The test involves exposing a cell line to extracts or leachates from the packaging material, followed by an assessment of cellular viability and morphology.
Our laboratory follows international standards such as ISO 10993-18:2015, which outlines the requirements for the biological evaluation of medical devices. This standard ensures that all tests conducted are consistent with recognized protocols designed to protect patient safety.
In this service, we offer a range of services including sample preparation, test execution using standardized techniques, and comprehensive reporting aligned with regulatory expectations. Our team has extensive experience in handling sensitive biological samples and understands the nuances involved in preparing these specimens for testing.
The cytotoxicity test is just one part of a broader package of tests required under ISO 10993 standards. We also provide other services such as biocompatibility assessments, genotoxicity evaluations, and irritation potential studies, all tailored to meet the unique needs of ophthalmic product development.
Our laboratory uses state-of-the-art equipment and follows strict quality control procedures to ensure accurate results every time. By leveraging our expertise in this area, you can be confident that your products will not only pass regulatory requirements but also maintain high standards of safety for end-users.
| Standard Code | Description |
|---|---|
| ISO 10993-18:2015 | Biological evaluation of medical devices - Part 18: Specific requirements for cytotoxicity testing of materials and articles in contact with the ocular tissues. |
| ASTM F734 | Cytotoxicity test method for biocompatible materials used in contact lens cases and other ophthalmic products. |
Applied Standards
| Standard Code | Description |
|---|---|
| ISO 10993-18:2015 | Biological evaluation of medical devices - Part 18: Specific requirements for cytotoxicity testing of materials and articles in contact with the ocular tissues. |
| ASTM F734 | Cytotoxicity test method for biocompatible materials used in contact lens cases and other ophthalmic products. |
Benefits
- Achieve compliance with international regulatory requirements.
- Ensure product safety before release to market.
- Gain confidence in the biocompatibility of your packaging materials.
- Streamline the regulatory approval process for new products.
- Reduce the risk of recalls due to adverse reactions.
Competitive Advantage and Market Impact
- Enhances product reputation by demonstrating commitment to safety.
- Promotes faster market entry through streamlined regulatory approval processes.
- Increases customer trust and loyalty, leading to higher sales volumes.
- Supports continuous improvement in product design and packaging materials.
