PDA EU00107 Container Closure Integrity Testing - Basic Course

Copenhagen, Denmark
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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

Standard Registration

Member Price

€ 2.090

Non-Member

€ 2.090

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

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 [email protected] 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, 25 April 2024

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, 26 April 2024

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

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.

Clarion Hotel Copenhagen Airport

Ellehammersvej 20
Copenhagen, Denmark , Denmark

PDA Europe recommends two hotels where you can reserve bedrooms at a reduced rate for that event.

To secure your room, please use the following booking code “PDA Europe”.

Clarion Hotel Copenhagen Airport
Ellehammersvej 20
2770 Kastrup , Denmark

Metro
Take line M2 from central Copenhagen to Copenhagen Airport (approx. 10-15 mins). Then walk through the passageway straight into the hotel lobby.

From the airport
Walk through the passageway from Terminal 3 and straight into the hotel lobby (approx. 2 mins).

Comfort Hotel Copenhagen Airport - The Hangar
Ellehammersvej 18
2770 Kastrup , Denmark

Metro
Take line M2 from central Copenhagen to Copenhagen Airport.

From the airport
The hotel is just a 5-minute walk from Terminal 3.

How to Get Here
By Air Unlock discounted pricing with the following code DEAPILO and simply use the provided link below.
By Other Options By Train: Unlock discounted pricing and simply use the provided link below.