Confarma

Medical devices industry

Solvias provides analysis and testing for the medical technology industry, medtech, and its associated products. We offer services for all stages of medical product development, from R&D to commercial QC.

R&D

  • Packaging testing (sterility, integrity)
  • Biocompatibility (ISO 10993, USP<87>, <88>)
  • Chemistry (extractable & leachables, cleaning validation)
  • Microbiology (steam sterilization process development and qualification, D-value determination)

QUALITY CONTROL FOR BATCH RELEASE & SITE MANAGEMENT

  • Microbiology (sterility test, endotoxins (LAL), bioburden, microbial evaluation)
  • Chemistry (hydrocarbon (HCT), particles, Total Organic Carbon (TOC))
  • Biology (cell-based assay, in-vitro pyrogen test, cytotoxicity)
  • Environments (room qualification, water analysis)

We have an expertise in the following applications:

  • Hyaluronic acid gel (NaHA quantification, BDDE detection)
  • Orthopedic
  • Spinal
  • Combination Product
  • Ocular

All our medtech services are performed according to GMP, CGMP (FDA approved), GLP, ISO 17025, ISO 9001 standards. To fully understand your analytical testing and service requirement, we believe that effective collaboration is essential. Our philosophy is to provide you with more than just reliable test results.