Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs)

Besheer, Ahmed; Mahler, Hanns‐Christian; Matter-Schwald, Anja; Barrenechea, Sergio Mompart; Vogt, M.; Chalus, Pascal; Heymes, Pauline; Pillow, Timothy; Kirste, Andrea; Favrod, Patrick; Joerg, Susanne; Mathaes, Roman

doi:10.1007/s11095-020-02784-1

Cited by 28 publications

(33 citation statements)

References 12 publications

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“…CSTDs from various manufacturers differ in materials of construction and design and have a wide range of hold-up volumes from 0.04 to 1 mL. 6 The large hold-up volumes in certain brands of CSTDs may result in preventing the full labelled dose being delivered to the patient and consequently patient underdosing. This is more apparent with biologics with low fill volume vial configurations.…”

Section: Proposed Approach For Demonstrating Compatibility With Cstdsmentioning

confidence: 99%

“…Adverse effects in patients a due to potential administration of particles (visible and subvisible). 16 Non-proteinaceous (from stopper coring/ fragmentation 6,11 and CSTD surface) and proteinaceous particles (resulting from lubricant/leachable-protein interaction). 5 Change to a soft rubber stopper, 12 use steam sterilized rather than gamma-sterilized stoppers, 13 and/or use an effective in-line filter during administration.…”

Section: Proposed Approach For Demonstrating Compatibility With Cstdsmentioning

confidence: 99%

“…To minimize the amount of effort required for the assessment, the decision tree was organized for assessments that could be paperbased to those requiring actual experiments. The deviceability risks can usually 6 be assessed with known CSTD hold-up volumes and product overfills, and/or experiments to evaluate stopper coring across a platform container closure system. Leachables and lubricant risks may be assessed through a paper-based evaluation or may require experimentation depending on the unique nature of the formulation.…”

Section: Proposed Approach For Demonstrating Compatibility With Cstdsmentioning

confidence: 99%

“…For example, a biologic that is exposed to an incompatible contact surface or excessive foaming during product withdrawal or transfer can become physically unstable, resulting in the introduction of protein aggregates, visible particles and/or subvisible particles into the dosing solution. Other risks associated with CSTD use may include possible lubricants and leachables, 4,5 stopper coring/fragmentation, 6 and stopper push-in. 7 at the device-to-vial interface.…”

Section: Introductionmentioning

confidence: 99%

“…Additionally, some CSTDs may contribute to dose inaccuracy, in cases where the device design and/or hold-up volume prevents complete withdrawal of the product from the primary DP container and/or transfer of the dose into the infusion container. 5,6 Typically, compatibility of a given product with various infusion component materials that may be used for dose preparation and administration is tested by the drug sponsor prior to clinical use. However, due to the practical limitations in testing all available CSTDs on the market with every DP, it is important to undertake a systematic risk-based approach to address the challenges associated with the use of CSTDs and permit the use of biologic drugs with the marketed CSTDs.…”

Section: Introductionmentioning

confidence: 99%

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An Industry Perspective on Compatibility Assessment of Closed System Drug-Transfer Devices for Biologics

Besheer

Burton

Galas

et al. 2021

Journal of Pharmaceutical Sciences

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The Formulation Workstream of the BioPhorum Development Group (BPDG), an industry-wide consortium, has identified the increased use of closed system drug-transfer devices (CSTDs) with biologics, without an associated compatibility assessment, to be of significant concern. The use of CSTDs has increased significantly in recent years due to the recommendations by NIOSH and USP that they be used during preparation and administration of hazardous drugs. While CSTDs are valuable in the healthcare setting to reduce occupational exposure to hazardous compounds, these devices may present particular risks that must be adequately assessed prior to use to ensure their compatibility with specific types of drug products, such as biologic drugs, which may be sensitive. The responsibility of ensuring quality of biologic products through preparation and administration to the patient lies with the drug product sponsor. Due to the significant number of marketed CSTD systems, and the large variety of components offered for each system, a strategic, risk-based approach to assessing compatibility is recommended herein. In addition to traditional material compatibility, assessment of CSTD compatibility with biologics should consider additional parameters to address specific CSTD-related risks. The BPDG Formulation Workstream has proposed a systematic risk-based evaluation approach as well as a mitigation strategy for establishing suitability of CSTDs for use.

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Section: Proposed Approach For Demonstrating Compatibility With Cstdsmentioning

confidence: 99%