Aseptic/Sterile Processing

Jul 02, 2006
Pharmaceutical Technology
This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.

May 01, 2006
Pharmaceutical Technology
There are few, if any, valid reasons not to install an isolator in a new aseptic processing facility.

May 01, 2006
Pharmaceutical Technology
The industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility.

May 01, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Calculations show the predicted contamination levels in cleanrooms with turbulent mixing air and with vertical unidirectional airflow when people are dressed in modern cleanroom clothing systems. Comparisons are made between operation theatres and cleanrooms.

May 01, 2006
Pharmaceutical Technology
Model organisms are useful when validating sterile filtration, but successful retention of the model organism does not always guarantee that effluent is sterile. The authors explore the various factors that influence sterile filtration.

May 01, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author explores the importance of the proposals to revise Annex 1 of the EU GMPs in the context of the desire for science-based, internationally respected GMPs. Commentary also is provided about the relationship between this annex and CEN–ISO cleanroom standards.

May 01, 2006
Pharmaceutical Technology
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.

Apr 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed.

Apr 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Performing D-value and population verification is critical in the acceptance criteria for allowing a new lot of biological indicators into a facility before acceptance and use of the lot in validation work or routine monitoring of sterilization cycles.

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.
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