Some Further Comments on Aseptic Processing Guidance, Or The Fool on the Hill | PDA Journal
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Technologies in use and on the horizon could change aseptic processing in ways that
seemed inconceivable years ago but approaches to aseptic process validation still need to …

On February 1, 1985, FDA published a Notice of Availability of a draft guideline on aseptic
processing of sterile drug products. The draft guideline, dated January 1985, provides …

This article reviews current industry practices and regulatory expectations for the aseptic
processing of sterile drugs. It provides comparisons and outlines points of tension between …

Continued technological improvement, beyond what is commonplace today, is the only real
way to achieve continued improvement in aseptic processing. s eptic processing is the met h …

Aseptic process simulation (APS) is a critical validation procedure performed before
implementing a new aseptically-manufactured product or aseptic process. It is the lynchpin …

This chapter will focus on a microbiology reviewer's observationson the evolution of the
barrier system for aseptic processing of pharmaceuticals and the development of standards …

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 …

INTRODUCTION The preparation of many parenteral products must be accomplished by
aseptic processing due to limitations of the formulation and/or container to withstand the …

* To whom all correspondence should be addressed. he aseptic process simu la ti on (APS)
is wi dely used for the va lida ti on of as eptic processing du ring ph a rm aceutical …