Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables

Suzanne Culleton

ISBN 10: 3346064794 / ISBN 13: 9783346064790

Published by GRIN Verlag, 2020

About this Item

Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables | Suzanne Culleton | Taschenbuch | 56 S. | Englisch | 2020 | GRIN Verlag | EAN 9783346064790 | Verantwortliche Person für die EU: GRIN Publishing GmbH, Waltherstr. 23, 80337 München, info[at]grin[dot]com | Anbieter: preigu Print on Demand.

Seller Inventory # 118002778

Bibliographic Details

• Title: Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables
• Publisher: GRIN Verlag
• Publication Date: 2020
• Language: English
• ISBN 10: 3346064794
• ISBN 13: 9783346064790
• Binding: Taschenbuch
• Condition: Neu
• Dimensions: 210W x 148H x 5D millimeters 210 millimeters width by 148 millimeters height by 5 millimeters depth
• Weight: 96 grams
• Seller catalogs:
  • Bücher

About this title

Synopsis

Master's Thesis from the year 2015 in the subject Medicine - Biomedical Engineering, grade: 1.1, course: MSc. Industrial Pharmaceutical Science, language: English, abstract: With the adoption of Disposable and Single-use manufacturing equipment on the rise, it is logical there is an industry push to develop a standardised set of testing requirements to thoroughly evaluate the impact of extractable and leachable (E&L) contaminants on patient safety. The main objectives of this work are to critically evaluate the preliminary research previously undertaken on the subject area of Single-Use Systems (SUS) with emphasis on the data currently generated from vendors of single-use systems, the need for harmonised supplier data, current methodologies and best practices employed for E&L testing, and also identification of key areas that warrant further study. This will be accomplished using both quantitative and qualitative research methods where primary data is sourced directly from interviews with experienced professionals in the field. The secondary information is obtained from the critical analysis of scientific publications, scholarly articles, databases, and use of statistical data generated from recent surveys on the challenges E&L present and how industry have addressed this matter thus far. From an extractables and leachables viewpoint the regulatory outlook is still quite uncertain. Some SUS suppliers deliver a very strong data package which satisfies the needs of the drug product manufacturer while others fail in this regard. So, in that sense the evaluation of extractables and leachables remains a grey area at present. The challenge for the industry now is to achieve uniformity of data across multiple single-use vendors to facilitate end user risk assessment and compliance for future regulatory submissions and better patient care.