Material Characterisation and E & L Studies
Drug delivery devices, pharmaceutical containers, single use process equipment, medical devices, cleaning validation studies; the degree of analysis required in each case can be difficult to define.
MET’s Extractables and Leachables Testing Laboratory now offers 5 service levels:
Level 1: Is suitable for surface contacting devices with transient or short term duration.
Level 2: Is suitable for medium risk devices: up to 30 days use, tissue contact.
Level 3: Is designed to validate implant and repeat use devices.
Level 4: Container closure analysis for low risk pharmaceutical products.
Level 5: In depth, validated analysis considering: extractables and leachables after a thorough risk analysis designed for intravascular, ophthalmic, inlaled and chronic use combination devices.
As the analysis moves up the levels the detail of the initial material review increases, along with the number of analytical techniques applied and the amount of method validation.
MET delivers a wide variety of analytical techniques to identify organic and inorganic substances (metals, volatiles, non volatiles). We work to ISO, USP and EP standards and methods. These programmes can also be combined with performance and sterility testing to provide complete design validation for your products.