Aseptic/Sterile Processing

Mar 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Analytical tools and methods that require less water and detergent are gaining interest for faster, more efficient cleaning.

Mar 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Adding a cleaning step to the field-testing protocol, and combining it with the data generated to register sanitizing and disinfectant agents under FIFRA and the CEN TC 216 work program, produces a sanitation-and-disinfection validation methodology that is cost-effective, simple, and time-saving.
Mar 01, 2006
Pharmaceutical Technology Europe
Clean rooms are areas in which it is essential that microorganisms are not allowed to proliferate because they could contaminate pharmaceuticals and directly affect human health.
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.
Nov 02, 2005
Pharmaceutical Technology
The authors present a new approach to risk assessment for aseptic processing that emphasizes the contributions of personnel.
Oct 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.
Oct 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.
Sep 01, 2005
Pharmaceutical Technology Europe
This article provides an overview of the important factors associated with air handling systems within pharmaceutical and biopharmaceutical facilities. It provides information on the need for these systems, design considerations and advice on the approach to commissioning and qualification.
Jun 01, 2005
Pharmaceutical Technology Europe
Possible cross-contamination issues should be eliminated at the early stage of the project. The project sponsor should ensure that all relevant personnel from the production, quality control, logistics, and maintenance departments, as well as engineering, are involved in the conceptual stages of a design.
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.
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