Choose Wisely: Considerations in Selecting Your Vial/Stopper/Seal Components
Primary packaging components play a critical role in maintaining the safety and efficacy of parenteral drug products. A number of factors must be considered when selecting a combination of components such as drug/container interactions, inter-component compatibility for maintaining container closure integrity (CCI), and component compatibility with manufacturing processes. This 6 hour workshop will provide an overview of these factors within the context of glass vials, elastomeric stoppers, and aluminum seals. Topics to be covered will include the processes used to manufacture these components, extractables and leachables, chemically-induced particulate formation, assessing the inter-compatibility of components, the impact of storage conditions on CCI, and recommended handling practices in fill-finish operations.
Agenda:
First Session: Basic review of primary packaging components (9:00 am - 12:00 pm; includes Q&A)
- Glass vials
- Elastomer stopper
- Aluminum crimp seals
LUNCH: 12:00-1:00pm
Second Session: Considerations for packaging selection (1:00 - 4:00 pm; includes Q&A)
- Drug-container interactions
- Container closure integrity
- Component performance on fill-finish lines
Up to 6.0 PDH Hours will be offered for this event; we will NOT be offering each session as a standalone segment.
Speakers:
Dr. Matthew Hall
Technical Affairs Director
Corning Pharmaceutical Technologies (CPT)
Dr. Bettine Boltres
Director Scientific Affairs & Technical Solutions, Glass Systems
West Pharmaceutical Services
Registration Information:
|
COST |
|
|---|---|
|
ISPE Members |
$70 |
|
Non-Members |
$90 |
|
Emerging Leader |
$45 |
| Student - ISPE Member (must show current student ID) | $0 |
| Student - Non-ISPE Member (must show current student ID) | $20 |