Key material attributes in E&L assessment, including material identity, construction, additives, pre-treatment and prior extractables/leachables knowledge.
The intrinsic properties of a material influence which chemicals it may contain, release or transform into potential leachables.
Material identity
Glass, elastomers, polymers, metals, coatings and composite materials have different chemical compositions and potential extractables profiles. Specific material identification is more informative than relying only on a broad category.
Material construction
Coatings, multilayer systems, adhesives and composite constructions can introduce additional chemical sources or alter migration pathways.
Additives
Colorants, antioxidants, plasticizers, stabilizers, processing aids and other additives can be relevant contributors to an extractables profile depending on the material and use.
Pre-treatment and processing of the material
Treatments such as washing, sterilization, irradiation, siliconization or other processing steps may modify the chemical profile of a material or component.
Existing E&L knowledge
Historical extractables data, supplier information, pharmacopeial information and prior product knowledge can substantially improve risk characterization and guide the scope of additional testing.
Frequently asked questions
Why is specific material identity important?
Because materials within the same broad category can have different compositions, additives and extractables profiles.
Do material additives matter for E&L?
Yes. Additives can be important sources of extractables or leachables.
Can coatings affect E&L risk?
Yes. Coatings can act as barriers, but can also introduce their own chemical species.
Does material pretreatment matter?
Yes. Processing such as sterilization or siliconization can change the chemical profile.
Can prior knowledge reduce additional testing?
It can support risk-based justification when the prior knowledge is relevant, reliable and applicable to the intended use.