Dynatec's Chemistry Department performs various analytical assays. Each assay is performed by qualified and experienced personnel. Each validated assay is accompanied by quality standards and is performed in accordance with national/international standards. A summary of those services/standards are:
Medical Device Assays
(ANSI/AMMI/ISO Standards 10993-7)
- Ethylene Oxide Residual Analysis
- Dissipation Validation/Parametric
(AAMI TIRI 9)
Environmental Protection Agency Assay A.O.A.C.
- Disinfectant Efficacy Assay
- United States Pharmacopeia Guidelines
- Total Organic Carbon
Method Development
- Spectrophotometric Analysis
- Gas Chromatography
Wet Chemistry
- Solvent Purity
- Total Solids
- Total Dissolved Solids
- Total Coliform
- E. Coli
- pH/Conductivity
Rapid Microbial Identification - GC Fatty Acid Analysis-Bacteria, mold and yeast is identified utilizing the MIS-System. Submit your environmental isolates to Dynatec's Chemistry Department for accurate and rapid analysis.
SEAL STRENGTH TESTER/ACCELERATED AGING STUDIES
Standard test method for Seal Strength of Flexible Barrier Materials (ASTM F88-89)
Accelerated Aging Studies
- Temperature/Humidity controlled chamber
- (ASTM F 1980) - Standard Guide for Accelerated Aging of Sterile Material Devices Packages
- (AAMI TIR 17) - Radiation Sterilization-Material Qualification
In addition, Dynatec has implemented the Win Wedge software system for seal strength assay analysis. Call our Chemistry Department at (915) 849-1322, email us your questions or:
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