About this training


This training on aseptic manufacturing facilities starts with an introduction to basic concepts: cleanrooms, airlocks, HVAC, isolators and RABS.

Then starting from the regulatory GMP requirements (US and EU) we learn what is needed to build and operate an aseptic manufacting facility.

This training includes the requirements of the new Eudralex Volume 4 annex 1 published in August 2022.

The training covers important areas such as floor plan design, HVAC requirements (pressure, air changes, etc.), qualification of cleanrooms according to ISO 14644.

  • Language: English
  • Duration: 6 - 8 hours
  • Audience for this training: project managers, project engineers, QA engineers, validation engineers with no or limited experience on pharmaceutical facilities


Highlights

Part 1: introduction

Understand basic concepts such as cleanrooms, airlocks, HVAC, isolators and RABS.

Part 2: regulatory background

Covers the regulatory GMP requirements (US, EU) including the new Eudralex annex 1. Learn where to find and how to meet regulatory requirements on aseptic manufacturing.

Part 3: intermezzo on contamination

Part 4: cleanrooms

Covers in detail cleanroom, HVAC and facility design.

Part 5: cleanroom qualification

A technical introduction to cleanroom qualification in accordance to ISO 14644 and Eudralex Volume 4 annex 1. Covers all qualification tests required by the new annex 1.

Part 6: operational controls

An overview of operational aspects such as maintenance, cleaning and disinfection.

Part 7: barrier technology

Introduction to isolator and barrier technology, also covering disinfection and transfer technologies such as VHP, dry heat, E-beam.



Pharmaceutical Facilities Training / Overview

  Introduction
Available in days
days after you enroll
  Regulatory background
Available in days
days after you enroll
  Contamination control
Available in days
days after you enroll
  Cleanrooms and facility design
Available in days
days after you enroll
  Cleanroom qualification
Available in days
days after you enroll
  Operational controls
Available in days
days after you enroll
  Barrier technology
Available in days
days after you enroll
  References and further reading
Available in days
days after you enroll

Take this course