PDA 808.2 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 live eLearning 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.

Day 1 of the training course will include an introduction to container closure systems, with a specific focus on pharmaceutical elastomers; an introduction to the elastomer manufacturing process; and an introduction to how elastomeric components are packaged and sterilized.

Day 2 of the training course will include a review on the testing of products in accordance with regional Pharmacopoeia standards, a review of the regulatory requirements applicable to elastomeric closures and aluminum seals, and an introduction on manufacturing technologies and processes for aluminum seals.

For more options and/or related training courses, please visit the page(s) below.

PDA Parenteral Packaging Training Courses

  1. Identify common types of pharmaceutical elastomers
  2. Recognize elastomer manufacturing technologies
  3. Understand the various elastomer applications, variations, and functionalities
  4. Understand critical elastomer manufacturing parameters
  5. Understand the origin of defects in elastomeric components and detect the defect classification
  6. Use commonly applied analytical methods to test elastomeric components and understand the requirements for each test
  7. Understand the regulatory requirements for elastomeric closures and apply them in practical situations

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Standard Pricing

Standard Member Price

$499

GovernmentMember Only

$499

Health AuthorityMember Only

$499

Early Career ProfessionalMember Only

$499

StudentMember Only

$499

AcademicMember Only

$499

Non-Member

$499

See Qualifying Criteria for Member Types.

Day 1

Introduction to Container Closure Systems and Pharmaceutical Elastomers (60 min)

  • Vials, PFS, Cartridges (with a focus on elastomeric and aluminum components)
  • Selection criteria and key considerations
  • Physical and chemical properties
  • Applications, variations, and functionalities
  • E/L profiles

Break (15 min)

Pharmaceutical Elastomer Manufacturing Process (45 min)

  • Manufacturing technologies
  • Understanding critical manufacturing parameters

Processing of Elastomeric Components (45 min)

  • Fundamentals of RFS and RTU components
  • Importance of siliconization and selection criteria
  • Basics of camera inspection
  • Sterilization choices and elastomer packaging selection

Q&A (45 min)

Day 2

Elastomeric Testing (60 min)

  • Understanding origin of defects
  • Defect classification (discussion of PDA TR76)
  • Commonly applied analytical methods
  • Test methods discussion (e.g. CCI, silicone, moisture retention, chemical identification)

Break (15 min)

Regulatory Requirements Applicable to Elastomeric Closures and Aluminum Seals (60 min)

Introduction to Aluminum Seals - Manufacturing Technologies and Processes (15 min)

Q&A (60 min)

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