Extractables and Leachables Test Strategies for SUT

Our FDA registered chemistry laboratories provide analysis of extracts identifying and quantifying single use systems extractables such as:

• Gas Chromatography Mass Spectrometry (GC-MS)
• Liquid Chromatography Mass Spectrometry (LC-MS)
• Static Headspace Gas Chromatography Mass Spectrometry (SH-GC-MS)
• Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES)
• pH
• Conductivity

Risk Assessment and Study Design for SUT Users

Assessing extractables and leachables is important for patient safety and to calculate any potential impact on the process and product. Therefore, Smithers recommends that an extractables and leachables risk assessment should be created for your biopharmaceutical manufacturing processes. When creating an assessment the following factors should be considered:

• The nature of the extractable species
• Process fluid
• Contact time
• Contact temperature
• Downstream processes, (holding tanks, diafiltration, chromatography etc.)

SUT Leachables Assessment

Making the right choices about where and how leachable assessments of SUS are performed can significantly affect timelines, testing costs and minimise impact of future materials changes (unfortunately they do happen). Smithers works with customers to find the best strategy that meets their needs.