Using extractables data from single-use components for extrapolation to process equipment-related leachables: The toolbox and justifications-Reference-Cited by-同舟云学术

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Using extractables data from single-use components for extrapolation to process equipment-related leachables: The toolbox and justifications

Published:2021-08 Issue: Volume:163 Page:105841
ISSN:0928-0987
Container-title:European Journal of Pharmaceutical Sciences
language:en
Short-container-title:European Journal of Pharmaceutical Sciences

Author:

Hauk Armin^ORCID,Pahl Ina,Dorey Samuel,Menzel Roberto

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference75 articles.

1. U.S. Food and Drug Administration, Code of Federal Regulations (CFR), Title 21, Part 211, Sec. 211.65 - Equipment Construction. 2017.

2. European Commission, EudraLex, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. 2010.

3. European Medicines Agency (EMA), Guideline on Plastic Immediate Packaging Materials. 2005.

4. U.S. Food and Drug Administration - Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics. 1999, 41.

5. United State Pharmacopoeia <1663>Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. 2018, 41, 7910–7924.

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1. Parylene C Coating Efficacy Studies: Enhancing Biocompatibility of 3D Printed Polyurethane Parts for Biopharmaceutical and CGT Applications;ACS Applied Bio Materials;2024-07-23

2. Cell and Gene Therapies: Challenges in Designing Extractables and Leachables Studies and Conducting Safety Assessments;Journal of Pharmaceutical Sciences;2024-03

3. A comprehensive study of the effect of elevated temperature on the extractability and rate of exaggerated and exhaustive extractions of medical devices;Journal of Pharmaceutical and Biomedical Analysis;2023-10

4. Modeling extraction of medical device polymers for biocompatibility evaluation;Regulatory Toxicology and Pharmacology;2023-06

5. Equivalence study of extractables from single-use biopharmaceutical manufacturing equipment after X-ray or gamma irradiation;International Journal of Pharmaceutics;2023-03

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