Case Study Using Gas Chromatography-Mass Spectrometry
During the manufacturing process for medical stents used in surgical implantation, a chemical release agent is used. The company later uses a "flash off" procedure to remove (burn off) any residue.
The customer delivered the release agent used, products it manufactured and the procedure calling for a flash off temp of 340°C. After the procedure, were the stents ready for surgical implant?
What NH Chemical Analysis Team Did
The staff needed to understand several key factors for this particular problem.
- Was the product able to withstand the "flash?"
- What were the positive and negative control points of the surfactant?
- Was 340°C sufficient to achieve the necessary burnoff?
- After the procedure, was the "part" clean?
We performed a solvent extraction on the stents and then analyzed the extract by Gas Chromatography-Mass Spectrometry. The resulting chromatograms showed surfactant peaks for all positive controls and no surfactant peaks for negative controls or for any of the actual test samples, thus verifying that all of the surfactant is removed by the 340°C flash off procedure.
Customer Benefit and Result
The client has independent verification that the methods and procedures used during the manufacturing process leading to sterile products is correct.
