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Parenteral Drug Association Connecting People, Science and Regulation ®

Container Closure Integrity Testing

Mar 21 - Mar 22, 2019 |
Mar 22, 2019 |
Hilton Molino Stucky Venice | Venice, Italy
  • Education
  • Europe
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This workshop focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to applying these testing methods for CCI verification throughout drug product lifecycle. The Workshop will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this Workshop, participants gain critical problem solving skillsthrough:

  • interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
  • hands-on testing training on the newest innovations and state-of-the-art instruments
  • real-world case studies.

Who Should Attend

  • Parenteral drug packaging engineers and formulation scientists
  • Laboratory scientific staff and managers
  • Parenteral manufacturing staff
  • Sterility Quality Assurance
  • Regulatory affair scientists
  • Pharmaceutical packaging component manufacturing staff

Learning Objectives

This workshop utilizes lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing, with focus on achieving the following key objectives:

  • Understanding up-to-date regulatory and pharmacopeia requirements on CCI.
  • Defining CCI requirements for various container and drug product types using a risk-based approach.
  • Explaining working principles of various CCI testing techniques and their practical applications, with focus on deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laserbased gas headspace analysis, mass extraction leak test.
  • Selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles.
  • Defining CCI testing method development and validation approach and best practices.
  • Avoiding common issues and pitfalls in CCI testing applications

Instructors

Lei Li, Ph.D, Associate Engineer Advisor Delivery and Device R&D, Eli Lilly
Lei Li currently serves as an engineer advisor at Delivery and Device R&D, Eli Lilly and Company. Lei has 9 years of experience in pharmaceutical and medical device industry, with focus on developing API and drug product packaging in support of clinical development and product commercialization, and establishing cold-chain distribution for biologic products. His current responsibilities include developing package integrity verification profiles for Lilly’s diverse pipeline portfolio, developing and validating CCI testing methods, and supporting commercial control strategy development for CCI verification throughout drug product and device life cycle. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Lei Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.

Thursday, 21 March 2019

9:00
Welcome and Introduction


9:15
Regulatory Requirements:
CCI Introduction, Regulatory Requirements, and Industry Trends


9:45
CCI Assurance throughout Product Lifecycle

  • Testing requirement definition – risk based approach
  • CCI Profile & Testing strategy development

10:30
Coffee Break

11:00
Introduction to Group Exercise #1:
Product life cycle testing and method selection


11:15
CCI Test Methods: Fundamentals and Overview

  • CCI defects and commonly used positive controls
  • “Sizing” CCI defects using gas flow dynamics
  • Evolution of CCI testing technology: liquid flow, gas flow, electron flow (electric current)

12:00
Lunch Break

13:00
CCI Test Methods: Fundamentals and Overview(continued)

  • Deterministic vs probabilistic definitions
  • Physicochemical methods vs microbiological methods: differences and correlations
  • Microbial and Dye Ingress Testing Basics
  • Seal Quality Testing
  • Introduction group exercise #2: Method Characteristics

14:00
Advanced CCI Testing Technologies

  • Vacuum and pressure decay
  • Mass Extraction
  • Headspace analysis
  • Seal Quality Testing
  • HVLD

15:00
Coffee Break


15:30
CCI Testing Technologies (continued)

  • Tracer gas (helium leak detection)
  • Seal Integrity method example (residual seal force)

16:00
Current Topics: Industry Best-Practices and Novel Technologies

  1. AMI Optical emission spectroscopy for CCI testing
  2. API Container Testing using HeLD; Review Helium leak detection video

17:00
Group Exercise #2: Method Characteristics

  • review, discussion

Day 1 Review, Q&A


17:30
End of Day 1

Friday, 22 March 2019

8:30
Application Case Studies – Section 1

  • Vacuum and pressure decay
  • Mass Extraction

9:10
Hands-on Training


9:50
Application Case Studies – Section 2

  • Headspace analysis
  • HVLD

10:30
Coffee Break


11:00
Application Case Studies – Section 3

  • Tracer gas (helium leak detection)
  • SQT (Residual Seal Force)

11:40
Instrument Demo and Hands-on Training


12:40
Lunch Break

13:40
Development and Validation of Integrity Test Methods

  • Method development best practices
  • Method validation strategy
  • Pitfalls and solutions

14:30
Approaches to CCI Testing Method Selection

  • Method selection considerations
  • Class discussion - examples

15:00
Coffee Break


15:30
Group Exercise #1: Method Selection Review, Discussion, Q&A


16:00
Class Discussion, Recognition, Certification


16:30
End of Workshop

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1595 Euro

All fees given in Euro and excluding VAT (22%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Exterior

Hilton Molino Stucky Venice
Giudecca, 810
30133 Venice
Italy
Tel: +39 041 272 3311
Hotel Website

Once a flourishing flourmill, Hilton Molino Stucky Venice has been beautifully restored and offers a different view of the magical city of Venice. Just 30 minutes from the airport, we also offer a shuttle boat service to the city center. With 379 rooms and suites, the largest Congress Center and the second largest spa in Venice, a collection of bars and restaurants and a stunning rooftop pool, our hotel is the perfect location for your stay in Venice.

The comfort of their guests is a commitment reflected in the quality and finishes of their 379 rooms. Designed to be a place to unwind, all the rooms offer elegant amenities, spacious marble bathrooms and comfortable beds. Treat yourself with an upgrade and enjoy breathtaking views or access to the Executive Lounge.

Experience a real taste of the Mediterranean in the elegant Aromi restaurant or savor the authentic flavors of Venetian cuisine at Bacaromi. Spoil yourself with Nutella desserts or relax with a coffee at the lounge. Sip a cocktail Skyline Rooftop Bar enjoying outstanding views over Venice.

PDA Europe has reserved a limited number of rooms until the 19th December 2018.
Book Your Room for the PDA Group Rate

Single Room € 209 per night*
Double Room € 239 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • VAT, Taxes and Service Charge will apply

How to Get There

Venice Marco Polo Airport – VCE
Airport Phone: +39 041 260 9260

Hotel direction: 17 km
Airport shuttle service:

  • Public Boat: €15 per passenger (one way)
  • Public Bus: €8 per passenger (one way)
  • Public Taxi: €35 per passenger(one way)

Parking

  • On-site parking, fee: 4 EUR hourly, 12 EUR daily

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4517

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