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Live eLearning - PDA 808.3 Characteristics of Pharmaceutical Elastomers and Aluminum Seals in Parenteral Packaging Systems

Jun 16 - Jun 18, 2020
10:00 AM
-
12:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

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 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, and an introduction to the elastomer manufacturing process.

Day 2 of the training course will include an introduction to how elastomeric components are packaging, sterilized, and a review on the testing of products in accordance with regional Pharmacopoeia standards.

Day 3 of the training course will include 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

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Tuesday, June 16, 2020

    Introduction to Container Closure Systems and Pharmaceutical Elastomers

    • 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

    Pharmaceutical Elastomer Manufacturing Process

    • Manufacturing technologies
    • Understanding critical manufacturing parameters
  • Wednesday, June 17, 2020

    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

    Elastomeric Testing

    • 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)
  • Thursday, June 18, 2020

    Regulatory Requirements Applicable to Elastomeric Closures and Aluminum Seals


    Introduction to Aluminum Seals - Manufacturing Technologies and Processes

Trainers

Renaud Janssen
Renaud Janssen
Datwyler Sealing Solutions
Rahul  Thakar
Rahul Thakar
Datwyler

Learning Objectives

  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

Who Should Attend

This training course is intended for professionals who are responsible for primary packaging components for pharmaceutical containers.

Departments
  • Quality Control
  • Quality Systems
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Research and Development
  • Regulatory Affairs
  • Validation
  • Packaging

Roles
  • Specialist
  • Supervisor
  • Manager
  • Engineer
  • Director
  • Scientist

Registration Fees

Register Now
Registration Type Price
Member $500
Non-member $500
Gov't/Health Auth./Academic $500

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