Extractables & Leachables Support Services
Comprehensive Extractables & Leachables (E&L) Support Services for Medical Devices, Pharmaceuticals, Packaging & Product Development
Extractables and Leachables (E&L) studies play an important role in evaluating materials that
may come into contact with pharmaceutical products, medical devices, biologics, packaging
systems, manufacturing equipment, and healthcare products. Understanding whether chemical
compounds can migrate from materials under various conditions helps organizations better
evaluate product quality, material compatibility, manufacturing processes, and long-term product
performance.
As medical devices, pharmaceutical products, and advanced biomaterials become increasingly
sophisticated, extractables and leachables evaluations provide valuable scientific information
supporting product development, material selection, manufacturing quality, and regulatory
readiness.
At CMDC Labs
provides professional Extractables & Leachables (E&L) Support Services for organizations throughout the United States. Our multidisciplinary laboratory combines analytical chemistry, material characterization, advanced spectroscopy, chromatography, and scientific expertise to help manufacturers, researchers, biotechnology companies, pharmaceutical organizations, and medical device developers better understand the chemical interactions between materials and their intended environments.
CMDC Labs is
accredited under
What Are Extractables & Leachables?
Extractables are chemical compounds that can be released from a material under aggressive
laboratory extraction conditions.
Leachables are compounds that may migrate from materials during normal manufacturing,
storage, transportation, or product use.
E&L investigations commonly evaluate:
- Medical device materials
- Pharmaceutical packaging
- Polymer components
- Elastomers
- Plastics
- Tubing
- Seals
- Coatings
- Manufacturing materials
- Biomaterials
- Single-use systems
- Product-contact components
Understanding these interactions helps organizations make informed decisions throughout product development and manufacturing.
Why Extractables & Leachables Studies Matter
Comprehensive E&L investigations help organizations:
- Better understand material compatibility
- Support product development
- Evaluate packaging systems
- Assess manufacturing materials
- Improve product quality
- Support risk assessments
- Strengthen quality systems
- Improve manufacturing consistency
- Support scientific research
- Generate dependable analytical data
These studies provide valuable scientific insight throughout a product's lifecycle.
Industries We Support
Medical Device Manufacturers
Medical device companies utilize E&L studies during biomaterial evaluations, implant
development, polymer investigations, packaging assessments, and product development.
Pharmaceutical Manufacturers
Pharmaceutical organizations evaluate packaging systems, manufacturing equipment, container
closure systems, processing materials, and product-contact components.
Biotechnology Companies
Biotechnology organizations investigate single-use systems, bioprocess materials, laboratory
components, and advanced healthcare technologies.
Medical Packaging Manufacturers
Packaging manufacturers utilize extractables and leachables evaluations to better understand
product-contact materials and packaging performance.
Industrial Manufacturers
Industrial companies evaluate polymers, elastomers, coatings, specialty materials, and
advanced manufacturing components.
Universities & Research Institutions
Research organizations utilize E&L investigations during biomaterials research, analytical
chemistry studies, and scientific innovation.
Applications of Extractables & Leachables Studies
Extractables and leachables investigations support numerous scientific applications, including:
- Medical device development
- Pharmaceutical product development
- Packaging evaluations
- Biomaterial investigations
- Material characterization
- Product comparison
- Manufacturing quality
- Material selection
- Research studies
- Scientific investigations
- Product validation
- Quality assurance
Reliable laboratory data supports informed technical and scientific decision-making.
CMDC Labs Extractables & Leachables Capabilities
CMDC Labs provides multidisciplinary laboratory services supporting E&L investigations across
multiple industries.
Material Characterization
Scientific evaluation of polymers, biomaterials, coatings, elastomers, plastics, packaging
materials, and medical device components.
Chemical Characterization
Analytical investigations supporting:
- Material composition
- Organic compounds
- Chemical impurities
- Manufacturing consistency
- Product comparison
- Research investigations
Packaging Material Evaluations
Scientific investigations supporting:
- Container systems
- Packaging materials
- Product-contact components
- Manufacturing materials
- Polymer systems
- Advanced packaging technologies
Medical Device Support
Extractables and leachables investigations support:
- Implant materials
- Biomaterials
- Medical-grade polymers
- Medical tubing
- Product-contact components
- Healthcare technologies
Product Development Support
Scientific investigations supporting:
- Material selection
- Manufacturing optimization
- Product development
- Material comparison
- Research initiatives
- Scientific innovation
Failure Investigation Support
E&L investigations may contribute to studies involving:
- Material degradation
- Chemical migration
- Manufacturing inconsistencies
- Material compatibility
- Product investigations
- Root cause analysis
Analytical Technologies Supporting E&L Studies
Depending on project objectives, CMDC Labs utilizes advanced analytical technologies
including:
- High-Performance Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- ICP-MS Analysis
- FTIR Analysis
- Raman Spectroscopy
- SEM Analysis
- XPS Analysis
- Material Characterization
- Chemical Characterization
- Advanced Spectroscopy
Combining multiple analytical techniques provides a more comprehensive understanding of
material composition and potential chemical interactions.
Benefits of Extractables & Leachables Support
Organizations utilize E&L investigations to:
- Better understand material compatibility
- Improve product quality
- Support product development
- Evaluate packaging systems
- Improve manufacturing consistency
- Investigate material performance
- Strengthen quality systems
- Support scientific innovation
- Reduce development uncertainty
- Generate reliable laboratory data
Comprehensive analytical investigations provide confidence throughout product development and manufacturing.
Complementary Laboratory Services
Extractables & Leachables investigations frequently support additional CMDC Labs laboratory
services, including:
- Medical Device Materials Testing Services
- Material Characterization Services
- Chemical Characterization Services
- Surface Characterization Services
- Surface Chemistry Analysis Services
- Analytical Chemistry Laboratory Services
- Trace Metals Analysis Services
- Failure Analysis Services
- Medical Device Testing Services
- Product Validation Support Services
These multidisciplinary laboratory capabilities provide comprehensive scientific support from early research through commercialization.
Why Organizations Choose CMDC Labs
Advanced analytical chemistry expertise
Material characterization capabilities
Medical device laboratory experience
Scientific collaboration
Product development support
Packaging material expertise
Responsive customer service
Nationwide laboratory support
Commitment to scientific excellence
Our objective is to provide dependable Extractables & Leachables support that helps organizations make informed scientific, manufacturing, and product development decisions.
Frequently Asked Questions
What are extractables and leachables?
Which industries require E&L studies?
What analytical techniques support E&L investigations?
Can Extractables & Leachables studies support medical device development?
Does CMDC Labs provide Extractables & Leachables support nationwide?
Supporting Product Safety Through Extractables & Leachables Investigations
Understanding how materials interact with pharmaceutical products, medical devices, packaging
systems, and manufacturing environments is essential for successful product development and
long-term quality. Extractables and leachables investigations provide valuable scientific
information that helps organizations evaluate material compatibility, improve manufacturing
processes, support innovation, and strengthen quality systems.
CMDC Labs combines advanced analytical chemistry, material characterization, spectroscopy,
chromatography, and multidisciplinary laboratory expertise to deliver dependable Extractables &
Leachables support tailored to each client’s scientific and technical objectives.
Whether your organization is developing medical devices, evaluating pharmaceutical packaging,
investigating biomaterials, supporting manufacturing quality, or conducting advanced scientific
research, our laboratory is prepared to provide reliable analytical data backed by scientific
excellence.
Request Extractables & Leachables Support Services from CMDC Labs
Whether you are a medical device manufacturer, pharmaceutical company, biotechnology
organization, packaging manufacturer, industrial manufacturer, healthcare organization, or
research institution, CMDC Labs Extractables & Leachables Support Services provide
advanced analytical chemistry expertise and multidisciplinary laboratory support to help you
better understand your materials, products, and manufacturing systems.
Contact CMDC Labs today to discuss your Extractables & Leachables investigation
requirements and discover how our laboratory can support your research, product
development, manufacturing quality, and scientific testing objectives.
PFAS Water Testing
Per- and polyfluoroalkyl substances (PFAS) have emerged as one of the most critical environmental and public health concerns worldwide. Often referred to as “forever chemicals,” PFAS compounds are highly persistent, resistant to degradation, and capable of accumulating in water systems, soil, and the human body over time.
Drinking Water Contaminant Analysis
Drinking water is one of the most critical resources for public health, and even trace levels of contaminants can pose serious risks. Contamination may originate from natural sources, industrial activities, aging infrastructure, or environmental exposure, making regular and precise testing essential.
Heavy Metal Testing
Heavy metals such as lead (Pb), arsenic (As), cadmium (Cd), and mercury (Hg) are among the most critical contaminants monitored across industries including food, pharmaceuticals, cosmetics, medical devices, and environmental systems.
Water Testing
Drinking water quality directly impacts public health, industrial operations, and regulatory compliance. Whether supplied through municipal systems, private wells, or industrial infrastructure, water must meet strict safety standards to ensure it is free from harmful contaminants.
