For over 10 years, Chromatosync BioLabs has directed biocompatibility testing for the clinical gadget and
pharmaceutical businesses. Our staff toxicologists have tried many gadgets with an assortment of
arrangements, applications and segment materials.
ChromatoSync BioLabs is situated in a shocking 22,000 square foot office in El Paso, NM. This best in class
office permits us to offer top quality testing administrations to our customers all through the world. The vivarium
contains a careful suite, necropsy lab, radiation lab and a few method rooms. The 26 specimen rooms
(counting a different SPF suite) are served by a devoted HEPA-separated HVAC framework. The
vivarium has abundant help regions, including an enclosure/rack washer, a different tidy up confine extra space, and
devoted example prep lab.
Microbiology Services, Analytical Chemistry, Quality
Affirmation, Administration and office bolster capacities
are housed in the second floor of the office. The structure
site can likewise oblige an arranged 18,000 square foot
extension.
With ISO 9001:2008 and ISO 13485:2003 ensured
activities, AAALAC certify offices, and 30 years of
experience, Pacific BioLabs is sure to meet your quality
also, administrative necessities.
Our accomplished staff can assist you with planning a financially savvy
wellbeing test program for your item. We give cites
inside 24 hours on most biocompatibility testing ventures. Furthermore, we are committed to furnishing you with clear,
elegantly composed reports and brief, customized administration. If it’s not too much trouble call Business evelopment at 510-964-9000 to
examine your testing prerequisites, or visit our site at PacificBioLabs.com.
Pacific BioLabs’ trying capacities for clinical gadget organizations incorporate the accompanying methodology.
Biocompatibility Tests QA/QC Testing Validation Support
Concentrates/Material
Portrayal
• Cytotoxicity
• Sensitization
• Irritation
• Systemic Toicity
• Genotoxicity
• Implantation
• Hemocompatibility
• Surgical Models
• Subchronic Toxicity
• Chronic Toxicity
• Bioburden
• AAMI/ISO Dose Audits
• Biological Indicator Tests
• Environmental
Observing
• Bacterial Endotoxin
(LAL)
• Microbiology/Sterility
Testing
• AAMI/ISO Sterilization
Approval
• Reusable Device
• Cleaning, Disinfection,
furthermore, Sterilization
Approval
• Accelerated Aging and
Steadiness Testing
• Package Integrity
Testing
• GC/MS
• LC/MS/MS
• USP Physiochemical Tests
– Plastics or Elastomeric
Terminations
• Sterilant Residues
• AA, IR, GC, HPLC
• Total Organic Carbon (TOC)
• Organic Solvent Residues
• Non-Volatile Residues
