Articoli correlati a Disposable Technology and Single-Use Systems. Regulatory...
Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables - Brossura
Sinossi
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.
Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.
Compra nuovo
Visualizza questo articolo
EUR 27,95
EUR 11,00 per la spedizione da Germania a Italia
Destinazione, tempi e costiRisultati della ricerca per Disposable Technology and Single-Use Systems. Regulatory...
Immagini fornite dal venditore
Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables
Print on DemandDa: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germania
Valutazione del venditore 5 su 5 stelle
Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. 56 pp. Englisch. Codice articolo 9783346064790
Quantità: 2 disponibili
Immagini fornite dal venditore
Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables
Da: AHA-BUCH GmbH, Einbeck, Germania
Valutazione del venditore 5 su 5 stelle
Taschenbuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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. Codice articolo 9783346064790
Quantità: 1 disponibili
Immagini fornite dal venditore
Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables
Editore:
GRIN Verlag, GRIN Verlag Feb 2020, 2020
ISBN 10: 3346064794
ISBN 13: 9783346064790
Nuovo
Taschenbuch
Da: buchversandmimpf2000, Emtmannsberg, BAYE, Germania
Valutazione del venditore 5 su 5 stelle
Taschenbuch. Condizione: Neu. Neuware -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.Books on Demand GmbH, Überseering 33, 22297 Hamburg 56 pp. Englisch. Codice articolo 9783346064790
Quantità: 2 disponibili
Foto dell'editore
Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables
Da: California Books, Miami, FL, U.S.A.
Valutazione del venditore 5 su 5 stelle
Condizione: New. Codice articolo I-9783346064790
Quantità: Più di 20 disponibili
Immagini fornite dal venditore
Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables
Da: preigu, Osnabrück, Germania
Valutazione del venditore 5 su 5 stelle
Taschenbuch. Condizione: Neu. 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: BoD - Books on Demand, In de Tarpen 42, 22848 Norderstedt, info[at]bod[dot]de | Anbieter: preigu. Codice articolo 118002778
Quantità: 5 disponibili
Immagini fornite dal venditore
Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables (Paperback or Softback)
Editore:
Grin Verlag 11/5/2019, 2019
ISBN 10: 3346064794
ISBN 13: 9783346064790
Nuovo
Paperback or Softback
Da: BargainBookStores, Grand Rapids, MI, U.S.A.
Valutazione del venditore 5 su 5 stelle
Paperback or Softback. Condizione: New. Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables 0.19. Book. Codice articolo BBS-9783346064790
Quantità: 5 disponibili