PDA EU00194 Advanced Contamination Control Strategy: A Key Element for Aseptic Processing and Sterilization

Albuzzano, Italy
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Program Highlights

The course will be held at Fedegari’s Tech Center, where participants will be able to discuss real-life problems while using Fedegari equipment to apply their new knowledge and capabilities.

Note   In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1 week in advance. Hard copies of course notes will not be provided to participants.

This training course offers a comprehensive background of knowledge for professionals involved in sterile product manufacturing. The participants will enhance their understanding of the complexities of various parenteral drug formulations and their compatibility with aseptic manufacturing processes and sterilization methods.

The course will discuss the development of an integrated and effective Contamination Control Strategy (CCS) and the implementation of a Quality Risk Management approach to identify and mitigate potential sources of contamination. Also hydrogen peroxide, as decontamination technology for ensuring CCS in aseptic environments, will be discussed.

Through case studies and interactive hands-on activities, the training course will provide insight into the aseptic environment and related manufacturing processes (i.e. critical components of filling machines, development and validation of wash-sterilization cycles, etc). The course will provide an overview of up-stream processes in aseptic manufacturing with focus on maintaining grade A and ensuring the sterility of components transferred to filling lines. Course attendees will review the microbial sterilization control procedures and the effectiveness of parametric release in modern pharmaceutical manufacturing in accordance to the EU GMP Annex 1:2022 guideline.

Key objectives:

  • Understand the intricacies of parenteral drug formulations in steam sterilization methods
  • Identify the aseptic environment and their associated manufacturing processes
  • Learn and discuss the role of hydrogen peroxide as a decontamination technology for ensuring effective CCS in aseptic environments
  • Hands-on experience in moist heat sterilization and hydrogen peroxide decontamination process
  • Avoid common issues and pitfalls in Aseptic processing and sterilization
  • Discuss the significant changes introduced by EU GMP Annex 1:2022 guideline

Who Should Attend:

  • Process Engineers
  • Process Developers
  • Validation Engineers
  • QA Managers
  • QC Managers
  • Heads of Production
  • Qualified Persons
  • Sterility Assurance personnell

Participants of the training course are required to bring comprehensive knowledge of sterilization technology/parameters e.g. sterilization assurance level.

Standard Pricing

Standard Member Price

€ 2.980


€ 2.980

See Qualifying Criteria for Member Types.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Tuesday, 12 November 2024

Welcome and Introduction

1. Consideration about the Peculiarity of Different Parenteral Drug Formulations

  • Overview on drug product compatibility with aseptic processes and terminal sterilization methods
  • Challenges on drug product formulation with chemical sterilization and decontamination methods
  • Opportunites for application of steam sterilization to new drug product formulation

Coffee Break

2. Challenges of Manufacturing Technologies for Advanced Parenteral Drugs

  • Overview on new drug product manufacturing processes; biologics, mRNA, ATMPs
  • Manufacturing challenges and new technologies trends; a new approach to sterility and Contamination Control Strategy approach

3. EU GMP Annex 1: Approaches to Sterility and Their Impact on Drug Quality

  • Overview of major changes introduced by EU GMP Annex 1:2022 guideline
  • Microbial sterilization control: Wrapping and sterilization of product contact equipment

Lunch Break

4. Parametric Release: Maintaining the Validated State

  • Overview of parametric release
  • Implementation of parametric release for compliance with EU GMP Annex 1:2022 guideline
  • Parametric release: A case study

Coffee Break

5. Contamination Control Strategy (CCS): A Systemic Approach

  • How to define an integrated and effective Contamination Control Strategy
  • How to implement risk managment

End of Training Course Day 1

Day 2

Wednesday, 13 November 2024

Introduction to Case Studies of Day 2: Overview on Aseptic Environment and Related Manufacturing Processes

6. Case Study 1: Preparing the Aseptic Environment for Filling Operation

  • Definition of critical parts of filling machines and how to handle and create the load for the steam sterilization
  • Strategy to develop and validate a wash-sterilization cycle for filling machine parts to match CCS requirements
  • Critical attributes to be verified after the steam-washing cycle

Coffee Break

7. Case Study 2: Upstream Process of Aseptic Manufacturing, Grade A Continuity, Deep Dive on Sterile Component Transfer

  • Overview on aseptic filling process preparation
  • Focus on sterilization process for rubber bulk elastomer and crimp
  • Automated handling and transfer process to filling line: common practices and trends

Lunch Break

Plant Tour

8. Case Study 3: Ready-to-Fill (RTF) Container: A Way to Mitigate Contamination

  • Overview on RTF container, sterilization strategy and steam compatibility
  • Steam as alternative process to Ethylene Oxide (EtO) for primary container sterilization to avoid chemical contamination
  • Focus on sterilization process for RTF cartridges and cycle composition phases

Coffee Break

Q&A Session

End of Training Course Day 2

Day 3

Thursday, 14 November 2024

Wrap-up of Day 2 and Questions - visit to Technical Center to see unloading machine

9. Practical Session: Challenges in Terminal Sterilization of Pre-Filled Syringes (PFS)

  • EU GMP Annex 1:2022 guideline requirements for extensive application of terminal sterilization processes
  • Overview on air-steam mixture process development
  • Practical session for terminal sterilization of filled PFS with air-steam mixture technology

Coffee Break

10. Hydrogen Peroxide as Decontamination Technology for Ensuring CCS in Aseptic Environments

  • Overview on decontamination process as a cleaning method to introduce raw material in cleanroom
  • Theory behind hydrogen peroxide decontamination mechanism on porous and non-porous materials
  • Cycle composition of hydrogen peroxide decontamination process; approach to process validation

Lunch Break

11. Hands-On Session: Hydrogen Peroxide Distribution Mapping

  • Analysis of porous load to be decontaminated and approach to cycle validation
  • Manipulation of biological indicator and chemical indicator

Q&A Session

End of Training Course

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Fedegari Autoclavi s.p.a.

SS 235 km 8
Albuzzano, Italy , Italy

Training Location

Fedegari Group
Fedegari Autoclavi s.p.a.
SS 235 km 8
27010 Albuzzano (PV), Italy

Hotel Nearby

PDA Europe recommends the reservation at the following hotels. A transfer during the event from and to these hotels is guaranteed.

The general terms of business are valid at the event hotels.

Viale Vittorio Emanuele II, 41
27100 Pavia - Italy
Tel.: +39 0382 303401
Fax: +39 0382 25225
Hotel Website

Viale Vittorio Emanuele II, 25
27100 Pavia - Italy
Tel.: +39 0382 303401
Fax: +39 0382 25225
Hotel Website

How to Get Here
By Air Nearest Airport: Linate Airport
By Car Transfer per Taxi to the Training Location Distance: 52 km Duration: 43 min Estimated Fee: 95 Euros