Mail: info@sterilize.it  – Linkedin: sterilize.it


  • Member Area
  • Registration
  • About us
  • Processes
  • Applications
  • Bookstore
  • Useful Links
  • Contact us
  • About us
  • Processes
  • Applications
  • Bookstore
  • Useful Links
  • Contact us

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.

 

[…]
  • author: Mauri Sergio

The content you requested is only available for registered users. Please, register to download the file.
It's fast and free. Register here.
If you are a registered user enter your e-mail address and password to log in.

• Download
PDF File

0
0
0
0

related articles

  • Non-heat terminal sterilization of controlled released material
  • A history of isolator and containment technology, Part 6: Development of the validation of isolators
  • Chemical Surface Bio- Decontamination Applied to Material Transfer into Sterile Enclosures
  • Implementing a fully integrated solution for the food canning industry
  • Moist-heat sterilization of blood bags

0 Commenti

Leave Reply Annulla risposta

Il tuo indirizzo email non sarà pubblicato. I campi obbligatori sono contrassegnati *

Search
  • Enter your keyword

  • Processes

  • Applications

  • Author

Recent articles
  • A History of Isolator and Containment Technology, Part 5: Development and use of sterilising agents with associated devices
  • A history of isolator and containment technology Part 4: Transfer devices
  • A history of isolator and containment technology Part 3: Non-flexible film isolators including RABS
  • A history of isolator and containment technology Part 2: Flexible film isolators
  • Importance of risk assessment for aseptic transfer in pharmaceutical compounding

Aseptic Processing Risk Assessment: The Simplified Akers-Agalloco Method

Emerging Gloveless Robotic Technologies in Aseptic Manufacturing for Personalized Cytotoxic Drugs

Scroll
Contact

Mail: info@sterilize.it
Linkedin: sterilize.it

Member Area
Accesso
Password persa
Process
  • Aseptic processing
  • Cleaning
  • Chemical bio-decontamination
  • Moist-heat sterilization
  • Sterilization
Application
  • Blood bags
  • Environmental Monitoring
  • Food
  • General
  • Hyaluronic Acid
  • Other applications
  • Package Integrity
  • Pharma – Liquids
  • Pharmaceutical compounding
  • Pre-filled syringes (PFSs)
  • Robotics
  • Sealed containers
  • Validation
Subscribe to newsletter

Subscribe to our newsletter to stay informed about our news and info.

Join here

© Copyright 2020 Sterilize.it. All rights reserved. Privacy Policy e Cookie

Fedegari Autoclavi SpA | Albuzzano - SS 235 Km 8, CAP. 27010 (PV) | REA: PV- 130961 | P.IVA IT00303010185 | PEC: amministrazione@pec.fedegari.com | Capitale Sociale Versato 5.000.000,00 € i.v.