Packaging/Packaging Materials – Challenges & Solutions
Objectives
In this conference you will learn which requirements apply for packaging material and pre-sterilized material (e.g., ready-to-use, ready-to-sterilize). You will get to know relevant GMP aspects for packaging materials (e.g., vials, stoppers) that influence the quality of the final product. In addition, practice-oriented presentations and case studies will guide you through the relevant requirements on qualification / validation, and controls for packaging materials, including text control.
Registration
Background
Currently there is a growing demand in the development of packaging materials (e.g. ready-to-fill, ready-to-use, sterile clean filling) for several enhanced Biotech applications. However, new GMP requirements for the sterile packaging material apply with the revised EU GMP Annex 1. In addition, there are various other requirements like testing on E&Ls, distribution testing and text and code control (e.g., Data Matrix codes required for serialization purposes).
This event will therefore deal with the current discussions and trends in the packaging operations and packaging materials:
- Regulatory Challenges & GMP requirements
- Primary and Secondary Packaging
- Text and Code Control
- Packaging Challenges in Aseptic / Sterile Manufacturing
- Microbiological Control
- Distribution Testing
The presentations will be provided in a practice-oriented way from the different viewpoints of suppliers of packaging materials / devices / services, and the pharmaceutical industry.
Target Audience
This event is designed for employees working in the pharmaceutical industry (including drug device combination products), for suppliers of packaging materials & devices and to all who have to deal with the manufacture, control and release of packaging materials. The key areas are
- Sterile Production
- Packaging material / Medical Devices
- Manufacturing / Processing / Assembling
- Quality Control
- Quality Assurance
Moderator
Dr Marcel Goverde, MGP Consulting
Detailed Programme
Wednesday, 20 March 2024
Primary and Secondary Packaging of Drug Substances
Jyotsna Agnihotry, Flavine Europe
- Primary and secondary packaging in the Biopharmaceutical industry
- Types of primary packaging
- Single Use Systems (SUS)
- Secondary packaging for Biopharmaceuticals
- Packaging of Biopharmaceuticals for safe storage and shipping (e.g., correct packaging to enable efficient filling, freezing, and transportation)
Regulatory Challenges in Primary Packaging Materials
Pirkko Lahti, Orion
- Regulatory demands for
- QC testing (routine, development)
- Extractables studies
- Leachables studies
Packaging Materials Challenges in Aseptic / Sterile Manufacturing
Sergio Cuevas Luján, Boehringer Ingelheim
- Packaging materials for aseptic manufacturing: a complex packaging for a complex process
- Safety, efficiency, sustainability in packaging design and packaging materials for aseptic processes
- Packaging materials validation for aseptic manufacturing
- New trends in packaging materials for aseptic manufacturing
Microbiological Control of Packaging Materials
Dr Marcel Goverde, MGP Consulting
- Regulatory Expectations
- Microbiological Specifications
- Testing Methods
Development and Validation of a Cloud-based System for Automated Text Verification
Dr Carsten Börger, Valicare
Frank Hessler, Schlafender Hase
- User requirements for automated text verification for leaflets and graphical artworks
- Good documentation in software development
- Comparison of internal software validation for release versus software validation of a COTS-software
- Delimitation of duties in cloud-based system
Distribution Testing: How to make sure, the Product makes it to the Destination?
Mahboobeh Rastegar, GfPS
- The significance of distribution testing and commonly applied standards
- Potential hazards on the transport field
- How to interpret the test results to optimize the packaging
- Improving the protecting function of the secondary packaging
- Subsequent testing on the primary packaging