Parenterals

May 01, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
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.

Mar 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for both regulatory and production purposes. This article describes one approach to identifying and validating the materials used in a disposable filling process.
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
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
By Pharmaceutical Technology Editors
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
By Pharmaceutical Technology Editors
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.
Nov 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A discussion of the validation and operation of two commercially available vapor-phase hydrogen peroxide decontamination systems is presented, based on a hands-on examination of both systems.
Oct 02, 2004
Pharmaceutical Technology
Big Pharma is ramping up capital spending in parenteral manufacturing at the same time that contract manufacturers are completing their own major investment programs.
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