Skip To The Main Content

Container Closure Integrity Testing for the Advanced User

Feb 27 - Feb 28, 2020
Wohlen, Switzerland

  • Education
  • Europe
Sold Out
Program Highlights
This Course will take place at the Wilco AG facilities.
Participants are encouraged to bring their own samples for discussion!
View Brochure

Overview

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!

Ask a Question

Agenda

  • Day 1
  • Day 2

  • Thursday, 27 February 2020

    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

  • Friday, 28 February 2020

    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

    Trainers

    Matthias Kahl
    Matthias Kahl
    WILCO AG
    Bio
    Matthias Kahl
    WILCO AG
    Matthias Kahl is Head of Research, Development and Laboratory Services of WILCO AG in Wohlen since 2018. He started in 2017 responsible for development of new technologies. After studying physics at the University of Erlangen in the field of solid state physics and physical metrology, he obtained his PhD in modern optics and laser technology at the University of Konstanz in 2006. This was followed by a position as deputy development manager in the field of high-precision material processing with lasers. Further tasks included innovation management, intellectual property issues, and collaboration in quality management.
    Horst Koller
    Horst Koller
    HK Packaging Consulting GmbH
    Bio
    Horst Koller
    HK Packaging Consulting GmbH

    Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 28 years’ industry experience. His consulting company focuses on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active member of the WG16 for the EDQM. He is a speaker on international conferences and holds customized trainings. He has an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim, Germany.
    David Riesop
    David Riesop
    AbbVie
    Bio
    David Riesop
    AbbVie
    David Riesop is an analytical chemist by education. After his PhD thesis in 2012 he started his career in the pharmaceutical industry at Baxter and held different positions including Head of QC. In 2017 he joined AbbVie where he leads a team of scientists in the R&D NBE Manufacturing and Container Closure Science department. His current responsibilities include the parenteral container closure system development for AbbVie’s diverse early and later phase projects with a special focus on Extractables & Leachables and Container Closure Integrity. His recent contributions have focused on the implementation of a new CCI control strategy supported by deterministic CCI techniques.

    Additional Information

    • Learning Objectives

      Learning Objectives

      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
    • Who Should Attend
      • R+D Scientists
      • Manufacturing Supervisors
      • QA Managers
      • Manufacturing Managers
      • QC Managers
      • Auditors
      Prerequisites: Basic understanding and practical experience with Container Closure Integrity Testing Technologies (as conveyed in the PDA course ‘Introduction to Container Closure Integrity Testing Technologies ’).

    Got a Question? We have answers

    Contact Us

    Travel

    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.

    Wilco AG

    Rigackerstrasse 11
    Wohlen, Switzerland
    Phone: +41 56 618 43 43

    Wilco AG
    • Accommodations

      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.

    • Amenities

    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

    Other Options

    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 30-40 minutes to the hotel.

    Directions

    Registration Fees

    Regular Price
    Registration Type Price
    All Participants €1.595

    All fees given in Euro and excluding VAT (7,7 %)

    * For this member type or discount, online registration is not available, please contact [email protected].

    Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

    GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

    CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

    Sponsors

    Become a Sponsor

    Interested in becoming a sponsor? Learn about opportunities and benefits.

    Request Information

    Exhibitors

    Attendee List Email Scam

    Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

    Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

    Become an Exhibitor

    Interested in becoming an exhibitor? Learn about opportunities and benefits.

    Request Information

    Media Partners

    Related Events

    Related Events

    Contact

    Program Inquiries
    Exhibition Inquiries
    Training Course Inquiries

    Tel: +1 (301) 656-5900
    [email protected]

    Tel: +49 (0) 30 43 655 08-10
    [email protected]

    Registration Customer Care

    Tel: +1 (301) 656-5900 ext. 115
    [email protected]

    PDA Members Save Substantially