Case Study Using Gas Chromatography-Mass Spectroscopy GC/MS
A medical device manufacturer that makes a low-density polyethylene bag had concerns over a list of known banned chemical and substances and wanted verification the final products did not contain any.
The client had an analysis done with another lab and they discovered phthalates and o-hydroxybiphenyl, chemicals known to be on the banned list. A complete analysis was needed to confirm the findings.
What NH Chemical Analysis Team Did
The staff needed to understand several key factors for this particular problem.
- What would be the best method needed to identify every compound present?
- Were all compounds found from the polymer or after-manufacture additions?
- Did the first lab "get it right?"
A portion of the LDPE bag was extracted with high purity methanol and a sample of this extract was injected into the GC-MS. Six contaminant peaks were discovered, three of them were hydrocarbon in nature and the other three were amides. The presence of these contaminants was likely caused by lubricating oils or waxes as well as mold release agents and polymer lubricants. None of the banned chemicals were detected in our analysis.
Customer Benefit and Result
The NHML Team was able to identify a number of residual chemicals from the materials supplied and confirm that none of the banned substances were present.
