Flexibility and cost-effectiveness for advanced aseptic production

Abstarct

The use of robotics and automation in the industry is not new. For several decades now, many assembly lines have utilized production robots in different functions to increase productivity. Although human operators result in a potentially risky activity in sterile areas, pharma manufacturing remains heavily human. This article discusses how to apply current isolation technologies with robotic systems to reduce the risk of microbial contamination in aseptic processes caused by human intervention.

Keywords: Aseptic manufacturing, isolators, robots, contamination control.

Introduction

In the last 50 years, aseptic manufacturing has evolved slowly. In the mid-1950s, the highefficiency
particulate air (HEPA) filters started to be adopted to perform most of the aseptic processing activities. The use of isolators for sterile processing was firstly introduced in the 80s. Since then, a critical point in isolators has been the reliability of gloves as manual operations were still required (1). The automation of aseptic processing and the creation of gloveless systems to avoid direct human activities can be considered a real revolution. An advanced aseptic process can only be achieved if the industry is able to take personnel out from its processing.

This automated approach aims to remove human interventions responding to the US Food and Drug Administration’s 2004 Guideline on Sterile Drug Products Produced by Aseptic Processing as well as the agency’s report on Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (2). In this perspective, Fedegari has presented at the last year PDA Parenterals conference in Munich, Germany, a gloveless fully sealed isolator that uses a robotic – GMP compliant – arm. This solution is currently in an advanced development phase and offers a flexible and modular solution for small-scale manufacturing of personalized, cytotoxic materials used for clinical trials. The revolutionary isolator is completely sealed and based on a batch system with no operator required.

It supports a completely automated fill/finish process – without the need for gloves and the resulting glove ports and gauntlets – guaranteeing a greater level of sterility assurance. The system includes Cleaning in Place (CIP) capabilities to remove the contamination generated by the process. Single-use material such as ready-to-use primary containers and closures, beta bags and disposal waste bags can be used within the system.