The adoption of Single Use Systems in biopharmaceutical manufacturing has greatly accelerated in recent years. Components of SUS may include:
- Process containers (bags)
Unfortunately, all product contact surfaces have the potential to release extractable material into a process. Smithers Rapra utilizes both standard and customized 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)
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 minimize impact of future materials changes (unfortunately they do happen). Smithers Rapra works with clients 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
For more information or to request a quote, please contact us.
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