When this applies
Before commissioning chemical characterisation of any consequence. Both ISO 10993-18 and current US FDA guidance expect the extraction conditions, the analytical methods and the analytical evaluation threshold to be justified in advance — a profile generated first and rationalised afterwards is where deficiency letters come from.
When to run it
First, ahead of the analytical work. Two weeks here routinely saves a repeat campaign, because the AET depends on the device’s clinical use and dose, and an AET set too high means the study missed things it should have found.
What you receive
A protocol defining the extraction conditions, the solvent set, the analytical methods and the analytical evaluation threshold with its justification — and, after the work, the report written against that protocol. Two weeks for the protocol.
What it does not settle
The protocol governs how the chemistry is done; it does not conclude on patient safety. That is the ISO 10993-17 assessment. Nor does it guarantee the outcome: a well-designed programme can still find a constituent that needs assessing.
Method
Prepared per ISO 10993-18 and current US FDA guidance. Extraction conditions, analytical methods and the analytical evaluation threshold are defined and justified before testing begins, and the report is written against the protocol.
Where it runs
The analytical work under this protocol is subcontracted to an ISO/IEC 17025 accredited, GLP certified laboratory, and the documentation is issued under Groenakker cover, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
The chemical characterisation arms the protocol governs, and the ISO 10993-17 assessment that interprets them. ChemTox bundles protocol, chemistry and assessment as one programme.
