European Aseptic Conference

Objectives

Reasons to attend this conference:

  • You will be informed on new regulatory and technological developments in aseptic / sterile manufacturing
  • You learn how current GMP and production requirements have to be implemented technologically in sterile manufacture
  • You will get case studies from pharmaceutical companies

Registration

Background

The revised EU GMP Guideline Annex 1 was published in August 2022 after extensive discussion and came into force mainly in August 2023. Among other things, the consequences of this revised Annex 1 will be presented and discussed with inspectors and industry representatives. The discussion on Annex 1 will be complemented by case studies from pharmaceutical companies on new technological developments in the pharmaceutical production environment.

Target Audience

The event is directed at specialists and managers from the pharmaceutical industry as well as at engineers and planners who have to deal with European Annex 1 and current aseptic technologies in clean areas in their daily practice.

Moderators

Dr Friedrich Haefele, formerly Boehringer Ingelheim Pharma
Frank Studt, gempex

Detailed Programme

Tuesday, 19 March 2024

Industry asks - Annex 1 unfortunately does not answer! - What to do?
Dr Ingrid Walther, Pharma Consulting Walther

  • From 16 to 59 pages - is everything equivalently clearer?
  • The role of Quality Risk Management: Is there room for interpretation?
  • The key to understand the guideline is to read it word by word?

Aseptic Production in the Light of the new Annex 1
Dr Frank Sielaff, Hessian State Office of Health and Care, Germany

  • (New) requirements of Annex 1
  • Dealing with the new requirements
  • First inspection experiences

Compliance in Aseptic Production from a QP-Perspective
Dr Rita Jacobs-Haage, Vetter Pharma-Fertigung

  • Definition Compliance
  • GMP-Compliance
  • Confirmation of GMP Compliance as a Qualified Person
  • Confirmation of GMP Compliance as a CMO / delineation of responsibilities – Quality Agreements

Particle Life Cycle Concept
Dr Philip Hörsch, Vetter Pharma-Fertigung

  • How to implement
  • What are the prerequisites
  • What does it tell about the product
  • What can we learn about the visual inspection process and operator qualification

Case Study: Critical Process Parameters for filling of Sterile Products with BFS Technology
Dr Martin Haerer, Rommelag CMO

  • Defining of critical quality attributes for the product
  • Correlation of Quality attributes with process parameters to guarantee sterility of the product
  • Results of a case study with a small volume parenteral container filled with BFS Technology

Advancing Aseptic Manufacturing: Insights and Best Practices from a Chief Quality Assurance Officer
Dr Hiva Hossein Tehrani, CinnaGen

  • Pre-Use Post-Sterilization Integrity Testing (PUPSIT
  • Upgrading filling machines to Restricted Access Barrier Systems (RABS)
  • Development of a comprehensive contamination control strategy
  • Aseptic Process Simulation (APS)

Small Volume sterile Manufacturing– Challenges derived from new GMP Annex 1
Marta Rodríguez-Vélez, Letipharma

  • Facing the implementation of new GMP Annex 1 in a small volume multiproduct manufacturing site
  • Contamination Control Strategy
  • Manufacturing technologies (RABS, SUS, automation) in small volume production
  • Filtering and PUPSIT in small volume manufacturing

Wednesday, 20 March 2024

Container Closure Integrity Testing (CCIT) and Biologics – Some Case Studies
Olaf Wegener, Siegfried
Dr Constantin Hozsa, Siegfried

  • Role of container closure integrity in pharmaceutical industry
  • Definition of CCI
  • CCI as a concept
  • Choosing a CCIT method for your (biologics) drug product
  • Product specific considerations, hurdles and pitfalls

Single-Use Design for Small-Volume Filling
Julia Mathy, Roche Diagnostics

  • Challenge: small-volume filling with small batch sizes and small amount of vials/syringes -> every drop matters; especially for more patient-centralized medicine
  • Presentation of possible SUA designs allowing ventilation, blow-down, water flush, etc. to minimize product loss at the start and during the batch
  • Full process chain (compounding to filling) will be evaluated, e.g. right DS amount, best filter size, etc.
  • Output of the presentation: Ideas on what can be considered if product loss in a single-use chain shall be minimized without impacting the processability of the product

Implementation and Execution of an active microbial Air Monitoring System into a sterile, radiopharmaceutical Environment
Dr Emad Albarouki, Particle Measuring System
Stefanie Ziesche, ABX advanced biochemical compounds

  • Process technical integration of active microbial air monitoring
    • Communication, control and installation
    • Sterilization cycles
  • The use of single use impactor heads for active microbial air monitoring in a sterile environment
  • Advantages compared to sampling with classical agar plates and stainless steel impactors or aspects of cleaning, sampling time, safety, false positives and ease of use
  • Validation of sampling time with single use impactors and measurement point positioning
  • Calibration and maintenance of the system in accordance with current regulations
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