Parenterals

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.
Oct 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
There is a growing need for patient-compliant dosage forms within the cancer therapeutics and biotechnology areas. Ease of administration, enhanced therapeutic efficacy, and reduced side effects are factors that differentiate drug delivery products from conventional dosage forms and provide a competitive advantage. This article reviews salient trends in the parenteral drug delivery sector within the realms of a changing regulatory environment, drivers to growth, and recent advances in this field. Challenges associated with bringing parenteral drug delivery concepts to commercialization are discussed.
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
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.

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.
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.
May 01, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination.
May 01, 2005
Pharmaceutical Technology
The complete elimination of human-derived contamination is possible only with the elimination of human intervention.
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