Fill-Finish

May 01, 2006
Pharmaceutical Technology
There are few, if any, valid reasons not to install an isolator in a new aseptic processing facility.

May 01, 2006
Pharmaceutical Technology
The industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility.

May 01, 2006
Pharmaceutical Technology
Any aseptic processing technology that allows intervention by gowned personnel during operation cannot be considered an advanced technology. Although a standardized definition of restricted access barrier systems has been developed, these systems fall well short of being classfied as advanced technologies.

Nov 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors focus on the effects of cellulosic materials during the performance qualification validation of a transfer barrier isolator used for the purpose of sterility testing.
May 01, 2005
Pharmaceutical Technology
Study results show that the state of a cleanroom clothing system–new or much used–influences the protection efficacy of the system.
May 01, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination.
May 01, 2005
Pharmaceutical Technology
The complete elimination of human-derived contamination is possible only with the elimination of human intervention.
May 01, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A ready-to-fill closed vial can improve aseptic filling quality and reduce process complexity.
Apr 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors argue that chlorine dioxide (CD) is a safe and effective decontaminating agent that can be used for challenging applications.The effectiveness of CD gas for sterilizing complex isolator systems is studied.
Mar 02, 2005
Pharmaceutical Technology
This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.
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