Thermo Scientific™

Nalgene™ Forced Extraction Study Reports

 Related applications:
Bottles and Accessories

Identify and estimate the amount of compounds that may be extracted from key components under extreme conditions. Thermo Scientific™ Nalgene™ Forced Extraction Study Reports enableconfidence in your validation studies. Leverage the baseline data to determine whether further leachable studies are warranted to meet any applicable regulatory requirements or expectations. An analysis protocol is available upon request (under confidential disclosure agreement/CDA) for review, defining the strategy utilized to perform the extraction process.

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Description

Studies were conducted on four different Thermo Scientific Nalgene product systems:

  • Nalgene PETG Square Media Bottles and Closures (natural and white HDPE)
  • Nalgene™ InVitro™ PC Biotainer Bottles and Closures (silicone liner and PP closure)
  • Nalgene PP Carboys and Closures (TPE Gasket and PP white closure)
  • Nalgene InVitro PETG Biotainer and Closures (PP liner and HDPE closure)

Three extraction solvents were used on each unit for the forced extraction process:

  • Water
  • Ethanol
  • Hexane

Each extracted solution was subsequently analyzed by:

  • Gas Chromatography / Mass Spectrometry (GC/MS) for volatile and semi-volatile organic compounds
  • Liquid Chromatography / Mass Spectrometry (LC/MS) for non-volatile organic compounds
  • Inductively Coupled Plasma (ICP) for metals and elemental extractables using an acid digested solution

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An analysis protocol is available upon request (under confidential disclosure agreement/CDA) for review, defining the strategy utilized to perform the extraction process.

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Documents

Manuals & protocols