Equivalence study of extractables from single-use biopharmaceutical manufacturing equipment after X-ray or gamma irradiation Article Swipe
Roberto Menzel
,
Ina Pahl
,
Samuel Dorey
,
Tanja Maier
,
Armin Hauk
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1016/j.ijpharm.2023.122677
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1016/j.ijpharm.2023.122677
Single-use (SU) devices and assemblies used as manufacturing equipment in the biopharmaceutical industry require comprehensive qualifications. These qualifications include the assessment of compounds released from SU devices in contact with the process fluids, and how these leachable compounds potentially influence process performance, drug product quality, and patient safety. SU suppliers need to provide comprehensive qualification data for several parameters, for both new products and product changes, such as changes in the sterilization process applied to the SU device. The introduction of X-ray irradiation as an alternative to the currently used and established gamma irradiation of SU devices represents a situation where robust data is required to demonstrate equivalency between these two radiation technologies. Here, we present the results of a comprehensive extractables study for three SU components, bags, tubing, and sterilizing grade filters, evaluated after X-ray and gamma-ray irradiation. The selected study conditions were set up to allow a direct comparison of the results from the two sterilization methods, and to allow conclusions to be made on the impact of irradiation type on the polymers and their additives. Orthogonal analytical methods are applied to identify and quantify all organic compounds present. The data package provided here supports risk assessments for application of irradiated SU equipment in biopharmaceutical manufacturing. The formation of reaction products and the fundamental chemical pathways are discussed and found to be independent of the irradiation type. The results demonstrate the equivalency of both irradiation methods for extractables from plastic components used in pharmaceutical and biopharmaceutical manufacturing.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1016/j.ijpharm.2023.122677
- OA Status
- hybrid
- Cited By
- 6
- References
- 34
- Related Works
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- OpenAlex ID
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All OpenAlex metadata
Raw OpenAlex JSON
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https://openalex.org/W4319159390Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1016/j.ijpharm.2023.122677Digital Object Identifier
- Title
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Equivalence study of extractables from single-use biopharmaceutical manufacturing equipment after X-ray or gamma irradiationWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
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2023-02-03Full publication date if available
- Authors
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Roberto Menzel, Ina Pahl, Samuel Dorey, Tanja Maier, Armin HaukList of authors in order
- Landing page
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https://doi.org/10.1016/j.ijpharm.2023.122677Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
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hybridOpen access status per OpenAlex
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https://doi.org/10.1016/j.ijpharm.2023.122677Direct OA link when available
- Concepts
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Biopharmaceutical, Irradiation, Sterilization (economics), Process engineering, Gamma irradiation, Materials science, Computer science, Biochemical engineering, Business, Engineering, Physics, Biology, Nuclear physics, Finance, Foreign exchange market, Exchange rate, GeneticsTop concepts (fields/topics) attached by OpenAlex
- Cited by
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6Total citation count in OpenAlex
- Citations by year (recent)
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2025: 5, 2024: 1Per-year citation counts (last 5 years)
- References (count)
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34Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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