Single Use Systems and Processing Equipment

Single Use Systems (SUS) are increasingly being used at all stages of the biopharmaceutical manufacturing process. The impact of extractables and leachables on these systems must be considered to ensure components are unadulterated.

The adoption of Single Use Systems in biopharmaceutical manufacturing has greatly accelerated in recent years. Components of SUS may include:

  • Filters
  • Process containers (bags)
  • Tubing
  • Connectors
  • Gaskets
  • Valves

Unfortunately all product contact surfaces have the potential to release extractable material into a process. Smithers Rapra utilises both standard and customised protocols to assess the impact of extractables and leachables on the use of these products.

Extractables and Leachables Test Strategies

Smithers Rapra can design studies to support your testing requirements. This may involve adherence to the full range of solvent and time points outlined in the BioPhorum Operations Group (BPOG) protocol or a subset of these conditions may suffice.  We try to accommodate requirements in the most cost effective manner by working alongside our customers technical teams.

Our FDA registered chemistry laboratories provide analysis of extracts identifying and quantifying 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 SUS Users

Assessing extractables and leachables is important for patient safety and to calculate any potential impact on the process and product. Therefore, Smithers Rapra 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.)

SUS 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 Rapra works with customers to find the best strategy that meets their needs. 

Supporting the Industry

To support the continued growth of this industry we are an active member of the ASTM E55 committee on the Manufacture of Pharmaceutical and Biopharmaceutical Products and the work item WK43975 “New Standard Determining and Characterizing BioProcess Extractables from Components, Subassemblies, and Assemblies Used in Single-Use Applications: Part 1-Preparation of Extractables Test Solutions”. 

Smithers Rapra is also a member of the Bioprocess Systems Alliance (BPSA), an industry-led corporate member trade association dedicated to encouraging and accelerating the adoption of single use manufacturing technologies used in the production of biopharmaceuticals and vaccines. We support users and SUS manufacturers with industry protocols such as the Parential Drug Association’s Technical Report No.66 and BPOG.

Contact Smithers Rapra about extractables and leachables testing

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