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Aseptic Filling Manufacturing

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  • Rob Walker
  • Director
  • Rob Walker GMP Consultancy Limited, United Kingdom
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KEY TOPICS

Introduction to Aseptic Manufacturing

Contamination Sources

Introduction to Sterilisation

Particle Counting, Clean-room Classification & Environmental Monitoring

Cleanroom Clothing Systems, RABS and Isolators

HVAC System Overview

Cleanroom Behaviours and Aseptic Practices

General Cleanroom Design Principles

Contamination Control & Cleaning

Component Preparation and Handling

Training features

Interactive sessions & practical group exercises

Individual case by case consultancy with the trainer

Comprehensive printed and digital course documentation

5H+ of Networking with industry experts

Case studies from the trainer's experience

Certificate of Completion issued by the Trainer

Key takeaways

Learn

• About Cleanrooms, RABS and Isolators

• Particle Counting, Cleanroom Classification and Environmental Monitoring

• Equipment decontamination/ preparation and sterilisation

• Aseptic process simulations and different methods for different dosage forms including sterile APIs

Understand

• The concept of sterility and Sterile medicinal products

• Potential consequences of poor aseptic practices

• Contamination Control & Cleaning

Gain

• Aseptic manufacturing regulatory requirements

• Accepted particle limits and airflow velocities

• Risk assessment approach for microbial contamination

REGISTRATION

Delegate Fee

from 2196 € Buy

CUSTOMIZE THIS TRAINING TO YOUR COMPANY NEEDS

Based on your requirements, we will build a practical training including content tailored to your specific needs, our cutting edge methodologies and relevant modules from our training portfolio.

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