NAMSA’s chemistry laboratory services provide analytical support for the development and quality audit of medical devices, reagents, and excipients. Most of our work in this area is instrumental analysis of polymers and other product components for purity, uniformity, composition, sterilant residues, and general extractables. The results for the clinical material characterize the material, giving it identity and reproducibility in product manufacturing.
We offer a comprehensive range of analytical chemistry testing services to help ensure product safety, quality, and consistency during all stages of development. Our technical specialists will work with you to design and implement special studies for medical devices and pharmaceutical container or closure systems.
Chemical and Material Characterization Test Procedures
- Physiochemical tests
- Fourier transform infrared spectroscopy (FTIR)
- High-performance liquid chromatography/mass spectrometry (HPLC-MS)
- Gas chromatography/flame ionization detector (GC/FID)
- Gas chromatography/mass spectrometry (GC/MS)
- Inductively coupled plasma spectrometry (ICP)
- Physical and mechanical tests
- Specific gravity
- Durometer hardness
- Gel-permeation chromatography (GPC)
- Differential scanning calorimetry (DSC)
- Analytical method development and validation
- ASTM extractables
- CFR extractables for food and beverage contact
- Container and closure leachables
- EO/EC/EG analysis
- Heavy metals, USP Methods 1 and 2
- International pharmacopoeia (BP, EP, JP, USP)
- Ion content analysis (chloride, fluoride)
- Melting point determination
- Moisture determination
- Particulate testing and analysis
- Protein testing
- Peptide and amino acids
- Purified water testing
- Thermal analysis
- Trace metals (ICP)
- USP plastics and container testing
As technologies change and offerings expand, this may not be the complete list of what we have to offer. If you do not see a test that meets your needs, please contact our Technical Sales & Service Department.
Extractables and Leachables
Extractables are chemical compounds that migrate from any product-contact material (including elastomeric, plastic, glass, stainless steel, and coating components) when they are exposed to a solvent. An extractable study exposes components or systems to conditions that are more severe than normally found in a real-use situation, with the goal of identifying as many compounds as possible that have the potential to become leachables.
Once these compounds are identified, a method development and validation should be performed to ICH guidelines. This ensures that interferences from the drug matrix solution or other medium exposed to the device or container can be dealt with and that appropriate detection and quantitation limits can be established.
Both the FDA and ISO mandate that:
- Containers and closures for human use be analyzed for extractable compounds.
- There be no toxic interaction between the drug product and the container.
- Note: Medical devices that will be used with a specific drug or that will come in contact with other solutions may also be tested using the same procedure as a container.
Leachables are chemical compounds, typically a subset of extractables, that migrate into a drug formulation, solution, or bodily fluid from any product contact material (including elastomeric, plastic, glass, stainless steel, and coating components), as a result of direct contact under normal process conditions or accelerated storage conditions. Leachables are likely to be found in the final drug product or to be released into the body.
Following the validation, the leachables study is carried out, often in conjunction with shelf life studies and at each pull point (varying by shelf life and storage conditions). The solution is evaluated to determine if the extractables did in fact become leachables. It may then be necessary to perform a risk assessment as a final step to make sure all identified leachables are within safety margins.
Are NAMSA’s services a good fit for your needs? Contact a NAMSA representative +1-866-666-9455 (+1-419-666-9455 if you’re outside the US) or through our site contact form.