RMS Foundation
Bischmattstrasse 12
2544 Bettlach
Switzerland
Phone +41 32 644 2000
METHODS
Leachables & extractables studies
A leachable/extractable study (L/E study) is an important part of the safety assessment of medical devices and pharmaceutical products, particularly packaging and delivery systems. These studies aim to identify potential contaminants that may migrate from the materials of the packaging or the components of a delivery system into the medical device and ultimately accumulate in the patient. These studies are conducted at an early stage of product development and are critical to ensure the safety and efficacy of pharmaceutical products as well as to meet regulatory requirements.
According to which standards do we test?
Where possible, we carry out our testing services in accordance with or based on these international standards:
- ISO 10993-12
- ISO 10993-18
- USP 232, USP 233 or ICH Q3D (R2)
- USP 1663 and USP 1664 (under development)
Which devices do we use?
- Capacity Compact Incubator Shaker: IKA KS 4000 i control
- Water purification system: ELGA Pure Lab Flex
- ICP-MS: Agilent, 7700X
- GC-MS: Thermo Trace GC 1310 coupled to a TSQ 9000 mass spectrometer
- LC-MS: external partner lab
- TOC/TN: Shimadzu TOC-L with ASI-L autosampler
- FTIR Microscope: Bruker LUMOS
- SEM/EDX: Zeiss Sigma 300 VP
For which material tests do we use this method?
We carry out leachables/extractables studies on a wide variety of test specimens, such as
- Implants (metallic or alloyed)
- Packaging (plastics)
- Needles, cannulas
- Syringe barrel
- Ceramic medical devices
- Dosing systems
- Plasters and patches
- Products under development
What you should know about this method?
Which analytical parameters are tested in an L&E study?
- Inorganic components (elements such as As, Cd, Hg, Pb and others)
- Organic components, which are subdivided into
- volatile organic compounds (VOC)
- semi-volatile organic compounds (sVOC)
- non-volatile organic compounds (nVOC)
How does an L/E study work?
If it is "only" about inorganic L/E, the study can be carried out without major clarifications.
When investigating VOCs, sVOCs and nVOCs (e.g. polymer components), some clarifications are necessary - please contact us.
Are all tests carried out by RMS?
We have in-depth expert knowledge and a wide range of analytical equipment with which we can carry out the majority of analyses ourselves. For analyses that we do not offer ourselves, we can fall back on reliable partner laboratories. The project management (and therefore your contact person) remains with RMS.
Are the RMS analyses accredited?
RMS is an ISO 17025 accredited analytical laboratory (accreditation type C). Many of the analyses have already been validated or are under development. New or customer-specific analysis methods can be validated by us.
