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Biological Risk Assessment

Life Sciences / Medical Device / Biological Risk Analysis

Reliable Material Characterization Services for Biological Risk Assessment

Complete materials characterization in accordance with ISO 100993-1:2018 plays a critical role in evaluating your medical device’s biological safety. We support testing to determine critical physical and chemical information based on the materials of construction, the nature and duration of body contact, and what safety and toxicology data exist. Our expert team conducts chemical characterization to establish your medical device biocompatibility by identifying and quantifying the chemical components present in the materials. This testing can be used to determine material toxicology, typically following the guidance of ISO 10993-18:2020. Given the wide variety of applications this data presents, partner with our team for comprehensive support and guidance for your unique product.

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Extractable & Leachables Testing

We perform chemical characterization studies to identify extractables, which are soluble substances removed from materials when challenged with solvent, time, and temperature extremes. These studies also identify leachables, chemicals that migrate from a medical device by the action of water and other liquids related to intended use of the device.

Extractable and leachable materials may be composed of organic and inorganic substances typically resulting from additives, lubricants, accelerators, monomers, and high molecular weight oligomers. These substances often arise due to incomplete polymerization, residual solvents, degradation products from temperature, absorption, hydrolysis, oxidation, corrosion, or dissolution, or from the process itself, like mold release agents and anti-static and anti-stick agents. Our highly experienced team supports identifying such materials and determining what this may mean for your product design, production, and compliance.

Polymer Molecular Weight

Material characterization testing often includes Polymer Molecular Weight Determination and distribution utilizing Gel Permeation Chromatography (GPC) and Refractive Index detection. Once the molecular weight distribution of a polymer material is known, the Inherent Viscosity can be measured and mapped back to the GPC data to determine average Molecular Weight values. This process provides a quick Quality Control check to detect lot to lot variations. Inherent and Intrinsic viscosity measurements are also determined using our automated viscometer.

Surface Cleanliness

Surface cleanliness testing is a common application for our material characterization services. Since materials and pieces used in medical devices may be handled multiple times, by multiple departments or specialty contractors this activity often supports quality control. This effort confirms the materials have been properly handled through these various steps.
Variations of a frequently used procedure may include rinsing with Purified Water for Injection (WFI), with or without agitation for a period at a specified temperature. The material is removed from the container and the rinsate is separated into aliquots for one or more analyses that typically include:

  • Total Organic Carbon (TOC), USP <643> or an in-house quantification method
  • Microbial Bioburden, USP <1227>
  • Bacterial Endotoxins (LAL), USP <85>, Kinetic Chromogenic or Kinetic Turbidimetric
  • Particulate Matter, USP <788> Method I Laser Particle Counting method
Elemental Impurities

We provide support assessing levels of elemental impurities in raw materials, in-process formulations, and finished pharmaceutical and medical device products. Our team offers analytical services to support compliance with Quality Control requirements, whether monitoring label-claim or demonstrating control of trace-level elemental impurities. These services follow guidance as published in the European Pharmacopoeia (EP) chapters 5.20 and 2.4.20 and the United States Pharmacopoeia (USP) general chapters <232> and <233>.

We have a dedicated laboratory space for the testing of inorganic analytes including elemental metals, anions, and cations. By dedicating laboratory space to this area of testing, we are in-step with the upcoming and changing regulations and ready to help you comply with more stringent testing requirements. Namely, we have recognized the significant shift from non-specific, colorimetric tests for heavy metals—which do not always provide accurate, quantifiable results—to the requirements as outlined by the EP and USP.

Material Characterization Lab

Raw Materials & Finished Goods
  • Formulation Excipients
  • Active Pharmaceutical Ingredients (API)
  • In-Process Formulations
  • Finished Products
Sample Preparation
  • Open vessel Digestion Blocks
  • Microwave Digestion
  • Inductively-Coupled Plasma Mass Spectrometry (ICP-MS, single and triple quadrupole)
  • Inductively-Coupled Plasma Optical Emission Spectroscopy (ICP-OES)
  • Flame-Aspiration Atomic Absorption Spectroscopy (AA)
  • Graphite-Furnace Atomic Absorption Spectroscopy (GFAA)
  • Cold-Vapor Atomic Absorption Spectroscopy (CVAA)
  • Ion Chromatography (IC), Low-level Anions and Cations
  • In-house Methods for Screening, USP Class 1, Class 2, and Class elements, by ICP-MS
  • Qualitative Screening Methods by ICP-OES
  • Quantitative Assays
  • Custom Method Development & Validation for Quantitative and Qualitative Assays

Integrated Laboratory Services  

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.

Additional Resources

Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.

Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.

Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.

Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.