Hi, old friends and new acquaintances, HERBIOTEK has further extended its service scope after the successful establishment of biological activity techniques. If you are interested in the service of extractables and leachables test for medical devices, you are welcomed to explore the influences on the safety impact of extractables and leachables with us.

Extractables/Leachables of medical devices are the terms to collectively refer to the substances leached/released during clinical use. The extractable/leachables generally include residue of biocides, process residues, degradation products, monomer, and the monomers or additives contained in raw materials (including stabilizers, antioxidants, plasticizers, colorants, etc.). Medical devices may lay leave short-term or chronic safety harm on human bodies through the extractables/leachables during the contact with human bodies.

According to the regulation of ISO 10993-1 or the most important regulation of medical devices, ISO 10993-18 (GB/T16886.18-2011), medical devices are assessed by their chemical characterization and extractable/leachables play important roles during the product R&D process. The monomer and additives of the polymers and other hazardous substances from the manufacturing equipment, primary and secondary package may migrate into the products under storage conditions.

The most important part of the safety assessment for extractables and leachables is to establish the allowable limit. Secondly, the released amount should be determined under the conditions that mimic the worst case in clinical use, then the extractable/leachables safety assessment report should be completed according to the judgment on whether the released amount exceeds the allowable limit under the estimated use condition. In the above procedures, the design and the validation of the analytical method used for the determination of the released amount of extractables and leachables is the critical support for the quality and reliability of the extractables and leachables safety assessment report.

Based on the previous practical experience on drug compatibility, HERBIOTEK performed the determination of extractables and leachables for medical devices according to the actual product characteristics and mimic the worst case in clinical use to acquire the maximum leach. By utilizing methods of extraction, selection of extraction solution, proportion, temperature, time, etc. (ISO10993-12), and the characteristics of the extractable/ leachables, the analytical evaluation threshold (AET) was assessed. The total design and validation of the analytical method are supported by specific scientific evidence and fulfill the requirements for safety assessment.

HERBIOTEK has professional experience for analysis and owns chemical analytical technical platform including the high precision instrument techniques such as HPLC/PDA, HPLC/ELSD, HPLC/MS, HPLC/MS/MS, GC/MS, and ICP/MS, providing the complete and total test program for the extracts contained in the medical devices and packing materials of products and for the leachables contained in the final product.