Manufacturing Technology Guide No.1: Aseptic Filling, Engineering, and Operation

The PDA Manufacturing Technology Guide No. 1: Aseptic Filling, Engineering, and Operation is designed to communicate the Parenteral Drug Association’s thoughts on the topic and encourage further dialog among industry, health authorities, and suppliers of technology and materials, taking into consideration the changes and needs of the modern, global, sterile, healthcare product manufacturing industry. It does not represent an industry standard or regulatory guidance. This document addresses topics relating to major technologies for sterile filling and extends to the point of container closure, with the aim of discussing key considerations, risk and benefits of each technology.

This guide provides an overview of the elements that should be considered in the selection of an appropriate filler technology and for the successful integration of the filling system into the broader aseptic operation. Precautions with regard to sterility assurance (SA) are paramount for both liquid and powder filling systems. Innovation in filling technology continues throughout the industry in an effort to improve filling precision, increase throughput, reduce the need for interventions, and improve SA. This document will serve as a comprehensive resource for the considerations and components to be included in any design project.