The Experts below are selected from a list of 198 Experts worldwide ranked by ideXlab platform

Patrick Favrod - One of the best experts on this subject based on the ideXlab platform.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs).
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs)
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Purpose Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. Methods In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. Conclusion These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.

Ahmed Besheer - One of the best experts on this subject based on the ideXlab platform.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs).
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs)
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Purpose Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. Methods In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. Conclusion These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.

Andrea Kirste - One of the best experts on this subject based on the ideXlab platform.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs).
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs)
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Purpose Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. Methods In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. Conclusion These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.

Hanns-christian Mahler - One of the best experts on this subject based on the ideXlab platform.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs).
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs)
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Purpose Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. Methods In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. Conclusion These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.

Anja Matter-schwald - One of the best experts on this subject based on the ideXlab platform.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs).
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.

  • Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs)
    Pharmaceutical Research, 2020
    Co-Authors: Ahmed Besheer, Hanns-christian Mahler, Anja Matter-schwald, Sergio Mompart Barrenechea, Martin Vogt, Pascal Chalus, Pauline Heymes, Timothy Pillow, Andrea Kirste, Patrick Favrod
    Abstract:

    Purpose Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP monograph was issued. The majority of the studies published so far on CSTDs have focused on their “Containment” Function. However, other important attributes for CSTDs with potential importance for product quality impact are not yet fully evaluated. Methods In the current study, we evaluated four sytems from different suppliers, in combination with different container closure systems (CCS), using solutions of different viscosity and surface tension. The different CSTD / CCS combinations were tested for (a) Containment (integrity) using a highly sensitive helium leak test, (b) the force required for mounting the vial adaptor, (c) contribution to visible and subvisible particles as well as (d) the hold-up volume. Results Results show that the majority of CSTDs may have leaks varying in size, and that some of them generated visible particles due to stopper coring and subvisible particles, both due to silicon oil and particulate contaminations of the Devices. Finally, the holdup volume was up to 1 mL depending on the CSTD type, vial size and solution viscosity. Conclusion These results show that there is a need to evaluate the compatibility of CSTD systems to select the best system for the intended use and that CSTDs may adversely impact product quality and delivered dose.