Sustainability/Green GMP

8./9. April 2025, Wiesbaden/Germany

Objectives

This conference track will take a closer look at and discuss the possibilities of sustainability, environmental thinking and energy saving also under GMP conditions. The extent to which regulatory requirements, quality demands and modern sustainability requirements fit together will also be a topic of discussion. Case studies will be used to present practical implementations and highlight improvement measures.

Registration

Register as a congress delegate for just 690 EUR/day!
This special offer is only valid until 31 December 2024!

Background

In the past, compliance with quality requirements and safety aspects in the manufacture of drugs, active ingredients, etc. was often the primary focus. Environmental aspects, energy costs, water consumption and the like were usually not at the top of the priority list. This has changed in recent years - under the influence of climate change, rising energy prices, increased transport costs and scarcity of raw materials. Buzzwords like Sustainability or Green GMP are heard more and more often. On the one hand because of the increasing environmental problems and on the other hand because of the rapidly rising costs for energy, water and raw materials. The challenge is often how to combine the requirements of GMP and sustainability.

Targe Audience

This conference track is aimed at all persons in the field of manufacturing, facility management, quality assurance and quality control who have to deal with the problems of suatainability aspects under the regulation of GMP.

Detailed Programme

Tuesday, 8 April 2025
09.00 - 17.30 h

How can Sustainability be integrated into a pharmaceutical Quality Management System? ... or is it already included?
Dr Andrea Bauer, ABC&Q

  • Definition of sustainability: not just "green"
  • Are sustainability elements already included in GMP regulations / ICH Q10?
  • How can existing structures and processes be used to promote sustainability?

Circular Economy Opportunities for the pharmaceutical Industry
Susana Santos, BIAL Portela & Cª

  • Relevance of the Circular Economy in the Pharmaceutical Industry
  • Strategies to extend the shelf life of pharmaceutical products
  • Strategic partnerships and reverse logistics
  • Efficient and clean use of energy in the production of medicines

The new F-Gas Regulation and its Impact on pharmaceutical Freeze-Drying
Thomas Beutler, GEA

  • The new F-Gas Regulation in force since March 2024
  • The changes and what to look out for when planning new freeze-drying lines.
  • What risks are there for existing systems. Can the old HFC refrigerants still be refilled? What alternatives to HFCs are already available today?

European Union – Supply Chain Directive, Green Deal and National Regulations like the German Supply Chain Due Diligence Act
Leonie Evans, Meisterernst Attorneys

From Compliance to Sustainability: The Green GMP Journey
Ana Cláudia Pinho, BIAL

  • Introduction to Green GMP and Sustainability
  • Sustainability Expectations and Stakeholders
  • Energy Efficiency
  • Process Optimization

Greenfield Project – A sustainable Manufacturing Building
io consulting/Erbe Elektromedizin

Wednesday, 9 April 2025
09.00 - 18.00 h

Process Load Profiles as a Basis for a Cost Efficient and Sustainable Design of Utility Supply Systems
Bianca Bohrer, PSM Saar
Peter Gross, PGC

  • High Level Equipment Operating Program in early project phases
  • Demand Simulation: Process load profiles as a basis for cost efficient Utility network design
  • Operating options for reducing energy consumption
  • Supply Systems: Additional Constraints by Volatile Energy markets for an optimized Design of Central Units and Storage Tanks
  • Calculation and Monitoring of Facility Benchmarks and KPIs like e.g. CO2/m²/year, kWh/m²/year, kWh per vial

Sustainability Strategies at Pekana
Dr Marius Beyersdorf, Pekana

Recycling and Cleanroom Garments
Carsten Moschner, CMC3

  • Cleanroom Garments made from recycled material - what is already available today
  • First test results and wearing tests with cleanroom garments made of recycled material
  • Recycling of worn cleanroom garments - the state of the art today and an outlook on future solutions

Sustainable Refrigeration Technologies: Overview and Implementation of innovative Air-Cooling Technology for Freeze-Drying Processes
Fabian Plaum, Hof
Christian Sonntag, Roche

  • Freeze-Drying Process Overview
  • Regulatory Requirements (e.g. F-Gases Regulation, PFAS Regulation) and their effects to industry
  • Sustainable Refrigeration Technologies for Freeze-Drying Process (liquid nitrogen, natural refrigerants, air as refrigerant)
  • Implementation of cold air technology for Freeze-Dryers (Case Study by Roche Penzberg)
  • Decision Criteria for the technology

Sustainable Heat and Cooling Systems – the LUnA Projekt
Michael Eberhard, Abbvie
Thomas Frank, Refolution

Understanding the "Hidden Factory" in pharmaceutical manufacturing
Dr Frank Thielmann, Takeda

  • What are the special challenges in pharmaceutical production?
  • What approach is chosen for the optimization of business processes and what challenges do we face when automating business processes?
  • How can the improvement of manufacturing and business processes be linked?

Programme last upated: 12 November 2024

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