Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

For aseptically produced products, contamination control is critical. As a result, various associations and regulatory bodies have published guidance documents on the many safeguards required to ensure compliance with requirements. Most recently, industry has been awaiting the revised Annex 1 guidance from the European Union, which is currently still under consideration in draft form. Additionally, there is an increasing proportion of products in development that cannot be terminally sterilized, meaning there is a rising need for efficient aseptic processing solutions. In a keynote session titled “Evolution of Aseptic Processing”, presented at INTERPHEX 2021 on Oct. 20, 2021, several experts discussed the evolution of aseptic processing and provided insights into some of the challenges and opportunities facing the bio/pharma industry today.

The session was moderated by Felicity Thomas, European editor, 

Pharmaceutical Technology, Pharmaceutical Technology Europe, 

. In this video, Felicity interviewed Rafael Beaus, Global Consultancy Manager, Azbil Telstar. Rafael spoke about Annex 1 and trends in aseptic production.

This video is part 4 of 5. The other speakers in this session were:

Part 1: Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex.

Part 2: Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG.

Part 3: Luke Stockhausen, Lead Process Engineer, CRB.

Part 5: Jordi Serrat, Product & Technology Director, Azbil Telstar.

Watch other videos in this keynote series:

Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies

Serialization on a Global Scale: Deep Dive into the US DSCSA & EU FMD

Articles

Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 4

. In this video, Felicity interviewed Luke Stockhausen, Lead Process Engineer, CRB. Luke spoke about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

This video is part 3 of 5. The other speakers in this session were:

Part 4: Rafael Beaus, Global Consultancy Manager, Azbil Telstar.

Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 3

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part three of four, 

serialization from a software and data management perspective

Watch part 1: serialization from a manufacturing perspective

Watch part 2: serialization from a packaging perspective 

Watch part 4: serialization from a regulatory perspective 

With the aggregation considerations for the US Drug Supply Chain Security Act (DSCSA) on the horizon and uncertainties about authentication of medicines in a post-Brexit Europe, questions about compliance—and the security of the drug supply—are at the forefront.

In this discussion, global supply chain experts examine implications of the DSCSA (specifically serialization and aggregation) and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD). 

As the aggregation considerations for the DSCSA approaches, what do companies across the bio/pharmaceutical supply chain need to tackle now, and what can they expect going forward? 

Within Europe, compliance with the delegated EU FMD regulation has been required since 2019. However, implementation of the delegated regulation has not been smooth sailing. In what position has Brexit left stakeholders with regards to medicines authentication? Has it been/might it be necessary to further update manufacturing and packaging lines to accommodate variances in regulations?

Experts from across the global supply chain will provide insight and answers to these questions.

 is the CEO of advanco, provider for Level 3 and Level 4 Item Level Serialization. Alf has more than 25 years of enterprise software industry experience. He has strong operational experience, specializing in high-growth businesses in Europe and the United States.

 is the president and CEO of Covectra, a leader in track and trace solutions. Steve has more than 30 years of experience in international business development and program management.

Watch other videos in this keynote series

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Software and Data Management | Part 3

. In this video, Felicity interviewed Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG. Richard spoke about the evolution of aseptic processing with a particular focus on isolators.

This video is part 2 of 5. The other speakers in this session were:

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 2

. In this video, Felicity interviewed Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex. Patrick spoke about the changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

This video is part 1 of 5. The other speakers in this session were:

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 1

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part two of four, 

serialization from a packaging perspective

Watch part 3: serialization from a software perspective

Watch part 4: serialization from a regulatory perspective

 is a technical services manager at Sharp, a provider of pharmaceutical contract packaging services. In her role, Lauren is responsible for supporting the development, documentation, implementation, and enhancement of Sharp’s serialization services platform.