When this applies
Whenever ISO 10993-18 chemistry will be submitted to the FDA. The agency's expectations for extractables studies go well beyond a laboratory's standard report: a justified analytical evaluation threshold, an explanation of solvent and extraction selection, method sensitivity and validation evidence, and a clear path from the compound list to the toxicological assessment. A generic laboratory report rarely meets that bar, and a deficiency letter on chemistry is a slow way to find out.
When to commission it
Before the chemistry starts. The protocol defines extraction conditions, analytical methods and the AET up front, which is what the FDA wants to see — a protocol written after the data exist is visibly post hoc. Allow two weeks between commissioning and the laboratory start date.
What you receive
A study-specific protocol issued before testing and a matching report issued after it, in Groenakker’s template or yours. Together they document the device description, extraction rationale, solvents and conditions, the AET calculation with its uncertainty factor, every instrument and method setting, the compound list with identification confidence, and the hand-off to the ISO 10993-17 assessment.
What it does not cover
The analytical work itself — the VOC, SVOC, NVOC and metals screens are ordered separately or as a ChemTox package — and the toxicological risk assessment, which is GRK-2001. It also does not replace a biological evaluation plan.
Method
A study-specific chemical characterisation protocol and report, written to US FDA expectations for ISO 10993-18:2020 data so the chemistry you submit is reviewable as well as correct. Groenakker writes the protocol against ISO 10993-18:2020 and current FDA guidance on chemical characterisation, agrees it with the laboratory, and after testing compiles the report from the laboratory data in the same structure, so protocol and report read as one document set.
Who does the work
In-house at Groenakker. The work is authored, reviewed and approved by Groenakker’s biological safety specialists under its ISO 13485:2016 certified quality system, and issued in Groenakker’s template or in your document template on request at no extra cost.
Usually ordered alongside
The chemistry screens it governs, the toxicological risk assessment (GRK-2001) that follows, and a biological evaluation plan where the overall testing strategy has not yet been set.
