Pharmaceutical elastomers are commonly applied in the form of stoppers, plungers, and O-rings for parenteral drug-delivery applications. Here, good sealing is an apparent property for effective drug containment; however, there are several other critical attributes that govern the selection of an appropriate elastomeric component for safe and efficacious drug-delivery.
In this two-day training course, you will gain insight into the fundamentals of pharmaceutical elastomers with practical considerations. Industry experts will describe component selection strategies, review manufacturing technologies, component processing and sterilization techniques. There will be a focus to understand the origin of defects and analytical tools applied for their characterization.
In addition, you will participate in a plant tour of Datwyler’s FirstLine® manufacturing facility in Alken, Belgium!
- Select an appropriate packaging container for drug delivery with a focus on elastomers and lined aluminum seals
- Explain the science and manufacturing principles behind elastomers for pharmaceutical packaging
- Evaluate the critical processing parameters that determines if RFS or RTU
- Discuss the evolution in the regulations that govern elastomeric closures
- Describe best practices in primary packaging selection
Standard Member Price€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
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Tuesday, 19 March 2024
Welcome & Introduction and Collecting Participants' Expectations
Introduction to Container Closure Systems
- Vials, Pre-filled Syringes, and Cartridges with a focus on elastomeric and aluminum components
Introduction to Pharmaceutical Elastomers
- Selection criteria and key considerations
- Physical and chemical properties
- Applications, variations, and functionalities
- Extractables & Leachables profiles
Pharmaceutical Elastomer Manufacturing Process
- Manufacturing technologies
- Understanding critical manufacturing parameters
Processing of Elastomeric Components
- Fundamentals of RFS (Ready-for-sterilization) and RTU (Ready-to-use) components
- Importance of siliconization and selection criteria
- Basics of camera inspection
- Sterilization choices and elastomer packaging selection
- Manufacturing technologies and processes
- Applications and functionalities
Plant Tour: Visit Datwyler's FirstLine Elastomer Manufacturing
- Manufacturing technologies and processes
- Key considerations, quality parameters, testing methods
End of Training Course Day 1
Wednesday, 20 March 2024
Different Coating Technologies and Their Unique Benefits
- Understanding the origin of defects
- Defect classification (discussion of PDA TR76 report)
- Commonly applied analytical methods
- Test methods discussion – for eg. CCI, silicone, moisture retention, chemical identification
Exercise: Defect classification
(All participants will see and be able to recognize some possible defects in Datwyler's products)
Regulatory requirements applicable to Elastomeric Closures and Aluminum Seals
- Pharmacopeial requirements
- PFAS (per-and poly-fluoroalkyl substances): current situation, potential solution, and consequences
- Recent changes/updates in USP <381> and Ph. Eur. 3.2.9
- FDA requirements & post-approval changes for container closures system/components
- Recent EU regulations on primary packaging
Case Studies and Best Practices
Q&A and Summary
End of Training Course
Elke Geuzens graduated with a doctorate in chemistry from Hasselt University, Belgium. Before she joined Datwyler in 2010 as a product support manager, she had several years of experience in the chemical industry. Currently, Elke is a technical key account manager and she has more than 10 years of experience in similar roles within the company.
In her current role, Elke consults with pharmaceutical and medical device companies on parenteral packaging solutions to develop safe and efficacious drug-delivery systems. She holds global responsibility for several key clients, where she is responsible for technical projects from the ideation to the commercialization stage.
Peter Loyen holds a Bachelor degree in Electronics. After working in the Automotive industry, he joined Datwyler in 1994. Peter has over plus 20 years of experience within Datwyler in multiple positions. In 2017, Peter became Technical Key Account Manager, supporting the profitable growth of Datwyler Healthcare through demonstrating industry-leading Technical Expertise inside and outside the Datwyler organization.
Tabassam Sharif has been with Datwyler since 2018 and is currently a Manager of Regulatory Affairs. He has a Master’s degree in natural sciences and has worked within the Regulatory Affairs discipline of the pharma industry for 15 years. In his current role, Tabassam holds global responsibility for submission and update of Drug Master Files with the health authorities in order to support pharma companies in seeking regulatory approvals. He is also a member of several standardization groups, such as the Ph. Eur. experts Group 16, ISO Technical Committee 76 / WG4, and PDA Task Force on TR 73-2.
Sponsorship and exhibit opportunities are not available for this course.
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Training Facility: Datwyler Pharma Packaging Belgium NVIndustrieterrein Kolmen 1519
Alken, Belgium ,
PDA recommends the reservation at the following hotel:
Sint-Jozefsstraat, 2-10, 2-10
Distance to the venue: 7. 1 km (15min by the car)
Please visit the hotel website for more information.