Parenterals

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.
Oct 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors review current industry practices and regulatory expectations for the aseptic processing of sterile drugs. They compare and outline critical issues in current manufacturing technology and capabilities with regulatory requirements.
Sep 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.
Jul 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The limitation-of-risks (LR) method can be used as an engineering tool in risk assessment work for the identification, minimization, and evaluation of potential airborne risks, and for the identification of adequate monitoring points.
Jun 02, 2004
Pharmaceutical Technology
The role of microbial testing to ensure the sterility of aseptically filled sterile products is explained, from the product development phase to in-process monitoring to finished product testing.
May 01, 2004
Pharmaceutical Technology
In spite of regulatory uncertainties, the industry continues to develop improved aseptic processing technologies.
May 01, 2004
Pharmaceutical Technology
FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.
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