Container Closure Integrity Testing for the Advanced User

Wohlen, Switzerland
Ask a Question Exhibitor Standard Contract Clause
Program Highlights
This Course will take place at the Wilco AG facilities.
Participants are encouraged to bring their own samples for discussion!
Note   In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1 – 2 weeks in advance. Hard copies of course notes will no longer be provided to participants.

This two-day training course provides detailed insights on Container Closure Integrity Testing (CCIT) on an advanced level. Participants will earn all about the development of container closure systems for sterile drug products throughout shelf-life.

Subject matter experts present the latest regulatory landscape and industry expectations for CCIT. Additionally, best practices for methods development, testing technologies, test set-ups, as well as the creation and handling of positive control samples are shown.

The course takes place at the Wilco facility in Wohlen/Switzerland and includes hands-on learning sessions for different types of equipment.
Participants are encouraged to bring their own samples for discussion!

After completion of the course the participants

  • understand the regulatory environment on an advanced level
  • can explain strengths and weaknesses of the technologies in detail
  • can select the appropriate method
  • understand different concepts of positive controls and can evaluate the pros and cons of different positive control strategies
  • understand and apply method development
  • understand and operate the methods on an advanced level
  • are enabled to evaluate their QC approach themselves

Standard Registration

Member Price

€1.595

GovernmentMember Only

€1.595

Health AuthorityMember Only

€1.595

Early Career ProfessionalMember Only

€1.595

StudentMember Only

€1.595

AcademicMember Only

€1.595

Non-Member

€1.595

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, 27 February 2020

Note   Training Location: Mercure Lenzburg Krone
Kronenplatz 20
5600 Lenzburg
Switzerland

9:00
Welcome and Introduction


9:15
Holistic CCI Approach


10:00
Regulatory Requirements:

  • USP<1207>
  • EU Annex 1
  • ICH Q9

10:45
Coffee Break

11:00
Technology Overview

  • Differential pressure
  • High voltage
  • Headspace analysis
  • Tracer Gas / Mass Spectroscopy

12:00
Test Method Selection

  • Understanding and application of relevant criteria
  • Adapted feasibility approach

12:30
Lunch Break

13:45
Positive Controls

  • Fundamentals
  • Types

14:45
Method Development and Validation

  • Process analysis
  • FMEA
  • Fixture qualification
  • Method qualification
  • Test method validation

15:30
Coffee Break


15:45
Manufacturing Control Strategy

  • QC lab or 100% inspection
  • Risk Assessment
  • Sealing and Capping Forces
  • Supply CCI in lieu of sterility on stability
  • Chain and end-users exposures
  • Visual Inspection
  • Leak Testing

16:30
Wrap-up Day 1


17:00
End of Day 1


19:00
Networking Event

Day 2

Friday, 28 February 2020

Note   Training Location: Wilco AG
Rigackerstrasse 11
5610 Wohlen
Switzerland

8:30
Recap Day 1 & Open Questions


    9:00
    Lab Session 1 (Hands-on)

    Positive Controls

    • Preparation
    • Pros and Cons
    • Verification with He Mass spec.
    Lab Equipment (DP/HSA)
    • Operation of lab equipment
    • Considerations on installation sites
    • Daily business considerations
    • Method development
    • Use of positive controls

    10:45
    Coffee Break


    11:00
    Hands-on Inline System

    • System presentation and training
    • Calibration procedures
    • Validation runs
    • Considerations on installation site
    • Daily business considerations

    12:15
    Lunch Break

    13:45
    Lab Session 2 (Hands-on) (cont.)

    • Operation of inline equipment
    • Daily business considerations
    • Considerations on installation site
    • Method development

    14:30
    Coffee Break


    14:45
    Product Life Cycle

    • Feasibility trials Implementation
    • Day to day use
    • Maintenance
    • Change control
    • New technologies
    • Retrofits
    • Line modifications

    15:30
    Wrap-up


    16:00
    End of Course
    Agenda is subject to change.

    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.

    Training Location Day 1

    Mercure Lenzburg Krone
    Kronenplatz 20
    5600 Lenzburg
    Switzerland

    Training Location Day 2

    Wilco AG
    Rigackerstrasse 11
    5610 Wohlen
    Switzerland


    Hotel Nearby
    PDA Europe recommends the reservation at one of the following hotel.
    The general terms of business are valid at the event hotels.

    Mercure Lenzburg Krone
    Kronenplatz 20
    5600 Lenzburg
    Switzerland
    E-Mail
    Tel: +41 62 886 65 65

    The Mercure Hotel Krone is situated below Lenzburg Castle, on the edge of the Old Town. It offers traditional yet creative cuisine and free parking in the garage.Many cosy corners and the terrace provide for an intimate atmosphere in the charming restaurant.The rooms are spacious and feature a balcony. Rooms with connecting doors are available on request.

    How to Get Here
    By Air

    From Basel Airport:

    Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 74km from the hotel. A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station, from which there is a direct train IR37 to Lenzburg train Station. A taxi takes approximately 50-60 minutes to the hotel.


    From Zurich Airport:

    Zurich airport (ZRH) is situated approximately 44km from the hotel. A direct bus (Line S2) runs every 30 minutes taking you to the Zurich train Station, from which there is a direct train IR37 to Lenzburg train Station. A taxi takes approximately 50-60 minutes to the hotel.

    By Car

    From Basel Train Station:

    From SBB train Station there is a direct train IR37 to Lenzburg train Station.


    From Zurich Train Station:

    From Zurich train Station there is a direct train IR37 to Lenzburg train Station