PDA EU00188 Characteristics of Pharmaceutical Elastomers and Aluminum Seals in Parenteral Packaging Systems
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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
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Agenda
Discover What's Happening Each Day
Tuesday, 19 March 2024
9:00
Welcome & Introduction and Collecting Participants' Expectations
9:15
Introduction to Container Closure Systems
- Vials, Pre-filled Syringes, and Cartridges with a focus on elastomeric and aluminum components
09:45
Introduction to Pharmaceutical Elastomers
- Selection criteria and key considerations
- Physical and chemical properties
- Applications, variations, and functionalities
- Extractables & Leachables profiles
Coffee Break
11:00
Pharmaceutical Elastomer Manufacturing Process
- Manufacturing technologies
- Understanding critical manufacturing parameters
12:00
Lunch Break
13:00
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
13:45
Combiseal
- Manufacturing technologies and processes
- Applications and functionalities
14:30
Plant Tour: Visit Datwyler's FirstLine Elastomer Manufacturing
16:15
Coffee Break
16:30
Aluminum Seals
- Manufacturing technologies and processes
- Key considerations, quality parameters, testing methods
17:15
End of Training Course Day 1
17:30
Dinner
Wednesday, 20 March 2024
9:00
Different Coating Technologies and Their Unique Benefits
10:00
Elastomeric Testing
- 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
11:00
Coffee Break
11:15
Exercise: Defect classification
(All participants will see and be able to recognize some possible defects in Datwyler's products)
12:00
Lunch Break
13:00
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
14:00
Case Studies and Best Practices
15:00
Q&A and Summary
16:00
End of Training Course
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Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Training Facility: Datwyler Pharma Packaging Belgium NV
Industrieterrein Kolmen 1519Alken, Belgium
PDA recommends the reservation at the following hotel:
HasHotel
Sint-Jozefsstraat, 2-10, 2-10
3500 Hasselt
Belgium
Distance to the venue: 7. 1 km (15min by the car)
Please visit the hotel website for more information.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
€ 2.090Non-Member
€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Sponsorship and exhibit opportunities are not available for this course.
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