In vitro Biocompatability Testing

Pace Analytical Life Sciences (PLS) has been supporting ISO 10993 testing of medical devices for more than ten years. We have continued to add capabilities and upgrade our analytical testing equipment and resources to support the chemical characterization of materials. Now, we have built a new, dedicated laboratory space to support In vitro biocompatibility testing. As we expand to add these new capabilities, our suite of testing capabilities include:

Cytotoxicity Testing

  • MEM Elution
  • Agar Diffusion
  • Direct Contact

Hemocompatibility Testing

  • Hemolysis (ASTM, human blood)
  • Complement Activation C3a and SC5b Assay
  • Partial Thromboplastin Time (PTT)
  • Prothrombin Time Assay (PT)
  • Platelet and Leukocyte count
  • In vitro Blood Loop (Thrombogenicity)

Genotoxicity Testing

  • Ames (Bacterial Mutagenicity)
  • Chromosome Aberration Test
  • Mouse Lymphoma Assay
  • In vitro Micronucleus Test

Quality You Can Trust

Pace Analytical Life Sciences (PLS) has established an effective quality system and has demonstrated a long history of compliance through highly successful audits performed by clients and regulatory agencies. Pace Analytical has a reputation for delivering quality data and has a strong culture of quality throughout the organization complete with tight procedural controls. Clients can expect quality compliance commensurate to the study stage and data quality objectives:

  • ISO / IEC 17025 accredited
  • Good Laboratory Practices (GLP)
  • Good Manufacturing Practices (GMP)

Download Evaluation of Medical Devices literature.