PDA EU00187 Characteristics of Pharmaceutical Elastomers 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 one-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.
- 1. Select an appropriate packaging container for drug delivery with a focus on elastomers and lined aluminum seals
- 2. Explain the science and manufacturing principles behind elastomers for pharmaceutical packaging
- 3. Evaluate the critical processing parameters that determines if RFS or RTU
- 4. Discuss the evolution in the regulations that govern elastomeric closures
- 5. Describe best practices in primary packaging selection
Agenda
Discover What's Happening Each Day
Thursday, 19 October 2023
09:00 Welcome and Collection of Participant's Expectations
09:15 Introduction to Container Closure Systems
- Vials, PFS, Cartridges with a focus on elastomeric and aluminum components
09:30 Introduction to Pharmaceutical Elastomers
- Selection criteria and key considerations
- Physical and chemical properties
- Applications, variations, and functionalities
- E/L profiles
10:30 Coffee Break
11:00 Pharmaceutical Elastomer Manufacturing Process
- Manufacturing technologies
- Understanding critical manufacturing parameters
11:45 Processing of Elastomeric Components
- Fundamentals of RFS and RTU components
- Importance of siliconization and selection criteria
- Basics of camera inspection
- Sterilization choices and elastomer packaging selection
12:45 Lunch Break
13:45 Elastomeric Testing
- Understanding 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
14:45 Coffee Break
15:15 Regulatory Requirements Applicable to Elastomeric Closures
- Pharmacopoeia requirements for elastomers and aluminum seals
- Recent changes / updates in USP <381> and PH. Eur. 3.2.9.
- FDA requirements & post approval changes for container closure system / components
- Recent EU regulations on primary packaging
16:30 Q&A and Summary
17:00 End of Training Course Day
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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.
PDA recommends the reservation at the following hotel
Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg,
Sweden
PDA Europe has reserved a limited number of rooms until the 15th August 2023.
Book your room at the PDA Group Rate via the above-mentioned reservation button.
For group requests over 6 bedrooms please send an email to [email protected]
Attn. Emelie Sandell
Just a 20-minute walk from the hotel you will find The Garden Society of Gothenburg - one of Europe's best-preserved 19th-century parks. At the other end of town you will find the Botanical Garden, a world-class botanical garden with over 16,000 species to admire.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
€ 1.055GovernmentMember Only
€ 1.055
Health AuthorityMember Only
€ 1.055
Early Career ProfessionalMember Only
€ 1.055
StudentMember Only
€ 1.055
AcademicMember Only
€ 1.055
Non-Member
€ 1.055
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
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 [email protected] 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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