Parenterals

May 01, 2009
Pharmaceutical Technology
The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.
May 01, 2009
Pharmaceutical Technology
The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.
Jan 07, 2009
PTSM: Pharmaceutical Technology Sourcing and Management
Outsourcing sterile manufacturing involves an integrated approach in product life-cycle management.
Nov 01, 2008
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A comparison of conventional cleanrooms, restricted access barrier systems, and isolators, shows the benefits of using isolators in high-potency drug manufacturing.
Nov 01, 2008
Pharmaceutical Technology
The author discusses the key issues to consider when using isolators such as containment, protection of personnel, the efficiency of biodecontamination cycles, sterility assurance levels, barriers and their integrity, and environmental impact.
Dec 13, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration issued a rule that clarifies its requirements for current good manufacturing practices for aseptic processing, water standards, and verifications standards.
Aug 02, 2007
Pharmaceutical Technology
This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.
May 01, 2007
Pharmaceutical Technology
Aseptic processing has advanced over the past several decades, yet the pharmaceutical industry is still accepting of its limitations, particularly as it relates to human intervention as a source of contamination. The authors explain the importance of further diminishing the role of operators in aseptic processing and the approaches and technologies needed to achieve that goal.
May 01, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Irradiation is an established method of sterilization for pharmaceutical products. Radiation sterilization can be achieved with gamma rays, electron beams, and X-rays. Each of these techniques has its advantages and disadvantages. The author describes these methods, the ways to find the correct sterilization doses, and the regulatory and safety concerns about irradation sterilization.
Nov 16, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
Research Triangle Park, NC (Nov. 13)-Eisai Inc. broke ground here for a new pharmaceutical production and formulation research and development facility for parenteral oncology drugs.
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