Risk Analysis for Aseptic Processing: The Akers-Agalloco Method

Feb 19, 2015
Aseptic processing is considered by many in this industry to be among the more difficult activities to execute properly. The number of variables that affect the safety of sterile products manufactured aseptically is substantial. In the design and operation of an aseptic production facility, it is essential that risk to the patient be minimized. This article presents a new approach to risk assessment for aseptic processing that emphasizes the contributions of personnel.
Author: Akers, James. Agalloco, James.
KEYWORDS: aseptic processing, risk analysis methods, sterile manufacturing, validation, aseptic filling, lyophilization, decontamination, isolation, microbial contamination.

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