Support for Companies Manufacturing Medical Supplies to Fight COVID-19 (Coronavirus)

Many companies are stepping up to the increased demand for medical supplies due to COVID-19 (Coronavirus) and newly released US FDA COVID-19-related guidance for the industry. EAG Laboratories is proud to support these innovators with testing and engineering services including:

Respiratory Protection Testing

  • Ventilator testing
  • CPAP Device testing
  • Airborne VOC and particle testing
  • Leachable analysis to determine the bio-compatibility of medical devices with breathing gas pathways (ISO 18562)
    • Tests for emissions of particulate matter (ISO 18562-2)
    • Tests for emissions of volatile organic compounds or VOCs (ISO 18562-3)
    • Tests for leachables in condensate (ISO 18562-4)

Medical Device Power Evaluation

  • Electrostatic discharge (ESD) testing
  • Engineering support for failure analysis
  • Electronic troubleshooting
  • Fault localization and root cause determination

Medical Equipment Cleaning Compatibility

  • Investigating the interaction of cleaning chemicals with medical equipment surfaces
  • Bleach or disinfectant degradation of certain plastics and polymers

Sanitizing Liquids & Wipes

  • Chemical compatibility studies with sanitizing wipes/sanitizer with household objects (anything made of plastic)
  • Quantitation of ethanol in liquid hand sanitizer (is it >60%)
  • Deformulation of commercial hand sanitizer (identify and quantify ingredients in a novel proprietary formula)
  • Quantitation of quaternary ammonium compounds in sanitizer

Supply Chain & Manufacturing Quality Support

Our surface, organic and microscopic analyses play an important role in supply chain support including contamination control during manufacturing, residual solvent analysis and surface cleanliness.

  • Vendor consistency
  • Sources of materials
  • Reliability of subcontractors
  • Testing for toxins including lead from solder or carcinogens outgassing from plastic
  • Verifying polymer/plastic material identity and similarity (for example, parts of an instrument supplied from multiple vendors)
  • Verifying metal and alloy material identity and similarity (for example, confirm two alloys from different suppliers or countries are equivalent)

Product Innovation & Improvement

From selecting the raw or starting materials to assessing a new manufacturing process, we help clients understand their surfaces and materials. This includes surface modifications to enhance bio-compatibility, materials purity and surface cleanliness.

  • Product development consulting
  • Specifying materials to be used in products, depending on the application
  • Verifying and identifying coatings and thickness (for example, protective coating to reduce corrosion or reactivity under certain circumstances)

Product Failure Investigation & Troubleshooting

When failures or problems occur, we design investigations from basic characterizations to extended troubleshooting projects. Our metallurgists, polymer and coating chemists, electrical engineers and pharmaceutical scientists have years of experience finding the root cause of problems.
  • Investigating materials related issues like strange smell or wrong color
  • Identifying unknown particles
  • Investigating adhesion problems
  • Verifying material properties including hardness and performance of a part that is stressed mechanically including pumps, valves or switches
  • Investigating product reliability and determining likely failure modes

EAG is here to help companies bring innovative, safe and effective devices to patients. We are ISO 9001:2015 and ISO 17025:2017 certified and cGMP and GLP inspected.

Would you like to learn more about Laboratory and Testing Support?

Contact us today for your laboratory and testing support needs. Please complete the form below to have an EAG expert contact you.

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