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Parenteral Drug Association Connecting People, Science and Regulation ®

Container Closure Integrity Testing

Mar 01 - Mar 02, 2018 |
Mar 02, 2018 |
Marriott Park Hotel Rome | Rome, 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.


Jennifer Roark, B.S., Manager Chemistry & Container Testing, Eurofins Medical Device Testing
As Manager of Chemistry and Container Testing, Jennifer Roark oversees testing to support the container and package testing needs of both pharmaceutical and medical device clients. Her group specializes in various CCI testing technologies such as vacuum decay, high-voltage leak detection, FMS oxygen headspace, pressure decay, and dye immersion. She also supervises the physiochemical testing associated with the USP, EP, and JP General Chapters on plastics, elastomeric closures, glass, and container performance testing. Jennifer has more than 22 years of analytical testing experience and serves as one of Eurofins’ leading subject matter experts for Extractables and Leachables Testing. She currently serves on ASTM Committee E55 on the Manufacture of Pharmaceutical and Biopharmaceutical Products, Subcommittee E55.04 General Biopharmaceutical Standards, leading the efforts to draft standard WK43945. Jennifer Roark has been involved with small molecule methods development and validation for over 12 years, and has co-published a series of articles on method validation.

Thursday,1 March 2018

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, 2 March 2018

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

1495 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

Marriott Park Hotel Rome
Via Colonnello Tommaso Masala 54
00148 Rome
Italy
Tel: +39-06-658821
Hotel Website

The Rome Marriott Park Hotel offers an uncommon blend of convenience and sophistication. With an outstanding location just minutes from Rome's Fiumicino Airport and a vast selection of top-quality amenities, our hotel sets the stage for a remarkable experience in the Eternal City.

Thoughtfully designed hotel rooms feature handcrafted furniture and elegant marble bathrooms, in addition to modern comforts such as a flat-screen TV. We're one of Rome's premier venues for any business meeting or event, with an astonishing 126,971 square feet of adaptable space and an expert planning staff. Satisfy your cravings here in Rome with delicious on-site dining, or take a leisurely swim in our seasonal outdoor pool.

Our well-placed hotel is only 10 miles from Fiumicino Airport and from world-renowned destinations, including Vatican City and the Colosseum. For added convenience, a shuttle service to and from central Rome is available.

PDA Europe has reserved a limited number of rooms until the 19th December 2017.
Book your room for the PDA Group Rate.

Single Room € 100 per night*
Double Room € 120 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service Charge will apply

How to Get There

Fiumicino Airport – FCO
Airport Phone: +39 06 65951

Hotel direction: 10.2 miles NE
Airport shuttle service, scheduled, fee: 5 EUR (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

Closed
https://store.pda.org/Meetings/Login.aspx?ID=4050

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