Parenterals

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FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of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.
Nov 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.
Aug 01, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.
May 01, 2003
Pharmaceutical Technology
Training for aseptic processing cleanrooms must be a dynamic process to meet job requirements and industry demands. The author discusses various approaches that may be taken to ensure a successful training session.
May 01, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.
May 01, 2003
Pharmaceutical Technology
Members of FDA, industry, and academia formed a working group within PQRI to openly discuss topics from a scientific perspective and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.
Mar 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
As parenteral drug delivery becomes more complex and sophisticated, excipients that can facilitate drug (or gene) delivery to specific therapeutic targets will be required. An overwhelming majority of these excipients are derived from natural sources.
Mar 02, 2003
Pharmaceutical Technology
The recently issued FDA concept paper about aseptic processing shows how the current guidelines could be expanded and makes recommendations for alternatives to traditional cleanroom installations such as isolator-equipped aseptic filling lines and blow?fill?seal equipment.
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