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Chemical Testing Services for Medical Devices  

 

AppTec offers the following chemical testing services for assessing the safety of medical device materials and manufacturing processing aids.  

 

FTIR Analysis

 

UV/Visible Spectrophotometer 

 

EO Residues per ISO 10993, Part 7 

 

Glutaraldehyde Residues 

 

Residual Water (Processed Human Tissue) 

 

Trace Metals 

 

Total Organic Carbon 

 

Osmolality 

 

Residual Carbohydrates 

 

Residual Protein 

 

Protein Assays (Modified Lowry) 

 

Physico-Chemical, USP Elastomeric Closures       

     Heavy Metals       

     pH Change       

     Reducing Agents       

     Total Extractables       

     Turbidity 

 

Physico-Chemical, USP Plastics (Aqueous and Nonaqueous)       

     Buffering Capacity       

     Non-Volatile Residue       

     Heavy Metals       

     Residue on Ignition 

 

USP Identification Tests & Assays  

 

USP Purified Water     

     (TOC, Conductivity) 

 

Karl Fischer Water Titration