PDA EU00107 Container Closure Integrity Testing - Basic Course

Malaga, Spain
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Program Highlights

Presentation on Technology, Instruments Demo, and Hands-on Training kindly supported by several suppliers of Container Closure Integrity testing systems and services.

This training course 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 training course 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 training course, participants gain critical problem solving skills through:

  • 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 training course 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, laser-based 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
Event Location
Higueron Hotel Malaga
Av. del Higuerón, 48, Malaga, Spain 29640 Get Directions

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
training-europe@pda.org
Registration Customer Care

Standard Registration

Member Price

€ 2.200

Non-Member

€ 2.200

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Thursday, 27 March 2025

9:00
Welcome and Introduction

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

09:45
Introduction

  • Testing requirement definition – risk based approach
  • CCI Profile & Testing strategy development
  • CCI Assurance throughout Product Lifecycle
10:30
Coffee Break

11:00
CCI Test Methods: Fundamentals

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

11:30
CCI Test Methods: Overview

  • Deterministic vs probabilistic definitions
  • Physicochemical methods vs microbiological methods: differences and correlations
  • Microbial and Dye Ingress Testing Basics
12:00
Lunch Break

13:00
CCI Testing Technologies

  • Vacuum and pressure decay
  • Mass Extraction
  • Headspace gas ingress
  • HVLD
  • Tracer gas (helium leak detection)

14:00
Special Topic: API Container Testing using Helium leak detection

14:30
Coffee Break

15:00
Application Case Studies (Part 1)

  • Tracer gas (Helium leak detection)
  • AMI Optical emission spectroscopy for CCI testing

15:40
Airborne Ultrasound

16:10
Hands-on Training

  • All instrument stations
    • HVLD station
    • Vacuum decay
    • Headspace
    • Helium leak detection
    • Mass extraction
    • AMI Optical Emission Spectroscopy

16:50
Day 1 Wrap-Up, Q&A

17:00
End of Training Course Day 1

Day 2

Friday, 28 March 2025

8:30
Welcome

8:40
Application Case Studies (Part 2)

  • Vacuum and pressure decay
  • Mass Extraction

9:20
Hands-on Training

  • All instrument stations

10:10
Coffee Break

10:40
Application Case Studies (Part 3)

  • Headspace gas ingress
  • HVLD

11:20
Hands-on Training

  • All instrument stations
12:00
Lunch Break

13:00
Special Topic - Residual Seal Force: A Powerful Vial Quality Test

13:30
Special Topic: Case Study: Systemic Evaluation of Vial Container Closure System Suitability at Frozen Condition

14:00
Approaches to CCI testing method selection

14:30
Coffee Break

15:00
Development and Validation of Integrity Test Methods

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

15:40
Group exercise:
Product life cycle testing and method selections

16:10
Group Exercise - presentations & discussion

16:30
End of Training Course
Agenda is subject to change.

Featured Trainers

  • Allison L. Dill, PhD

    Eli Lilly and Company

    Read Bio

  • Coralie A. Richard, PhD

    Eli Lilly and Company

    Read Bio

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Higueron Hotel Malaga

Av. del Higuerón, 48
Malaga, Spain 29640, Spain
Make a Reservation Online

PDA recommends the reservation at the following hotel

Higueron Hotel Malaga
Av. del Higuerón, 48
Malaga, 29640
Spain

PDA Europe has reserved a limited number of rooms until 28 January 2025.

Book your room now at the special PDA Group Rate via the reservation button above and enjoy exclusive benefits! Secure your discounted room rate, enjoy free parking, discounted access to the Spa, and relax with full access to the pool during your stay. Don’t miss out on these perks – reserve today!

How to Get Here
By Air From Málaga-Costa del Sol Airport (AGP): The hotel is about 20 km away. A taxi will take about 20 minutes, or you can take the C1 train from the airport to the Carvajal station, which is a 5-minute taxi ride or 15-minute walk to the hotel.
By Car The hotel is easily accessible from the AP-7 highway. Use GPS with the address Av. del Higuerón, 48. Parking is available at the hotel.
By Other Options Train: The Carvajal train station (C1 line) is the closest stop, about 2 km away. From there, you can take a short taxi ride or walk. Bus: Local buses serve the Fuengirola area, with a bus stop near the hotel.
Area Attractions
  • Fuengirola Beach (10-minute drive)
  • Bioparc Fuengirola (15-minute drive)
  • Picasso Museum, Málaga (25-minute drive)

Did you know? Málaga is one of the oldest cities in the world, founded around 770 BC by the Phoenicians, making it over 2,800 years old!