Abstract
With the emergence of barrier systems to isolate the operator from the aseptic fill and finish operations, new technical issues appeared regarding the introduction of material inside the barrier without compromising its integrity. The first transfer systems were complex and were not absent of contamination risks. New technologies have appeared with two major aims: simplify the operations and increase the reliability of the transfer. In this chapter, various transfer systems are identified, their advantages and weaknesses are assessed and finally various case studies are presented to illustrate the selection process which could lead to most appropriate solutions.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Abbreviations
- CIP:
-
Clean-in-place
- PBT:
-
Polybutylene terephthalate
- RABS:
-
Restricted access barrier system
- SIP:
-
Steam-in-place
- VHP:
-
Vapor hydrogen peroxide
- WFI:
-
Water for injection
References
Lechiffre B, Barbault D (2010) Rapid transfer port system: the key element for contained enclosures in advanced aseptic processing. In: Agalloco J, Akers J (eds) Advanced aseptic processing technology. Informa Healthcare, New York, pp 80–90
Lysfjord J, Porter M (2010) Barrier isolator survey, oral communication. In: ISPE meeting, Washington
Sigwarth V, Vanhecke P (2011) VHP airlock system, oral communication. In: ISPE meeting, Washington
Verjans B, Thilly J, Hennig H, Evrard P, Vandecasserie C (2007) A new system for the rapid transfer of sterile liquid through a containment wall. Pharmaceutical technology, April
Zandbergen J-E, Monge M (2006) Disposable technologies for aseptic filling. BioProcess Int 4(6):S48–S51
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 American Association of Pharmaceutical Scientists
About this chapter
Cite this chapter
Verjans, B. (2013). Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations. In: Kolhe, P., Shah, M., Rathore, N. (eds) Sterile Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 6. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7978-9_9
Download citation
DOI: https://doi.org/10.1007/978-1-4614-7978-9_9
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-7977-2
Online ISBN: 978-1-4614-7978-9
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)