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2023 PDA_Training-1988x680

PDA EU00180 Manage Your Isolator for Aseptic Processing

Mar 06 - Mar 07, 2024
Allschwil, Switzerland

Manage your Isolator for Aseptic Processing in Compliance with the Annex 1 and PICs Annex 2 A for ATMPs

  • Education
  • Europe

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This interactive training course takes place at the Skan Academy in the newly built Skan Headquarters in Basel.

On the first day, the focus is on glove handling. Theoretical units alternate with hands-on units, so that the participants can experience what they have heard live. On the second day, participants will get an overview of all aspects of the isolator. Here, too, both theory and hands-on units are offered.

During the training course there is enough time and space for exchange of experiences and discussions. For this reason, the training course is designed for a limited number of participants only.


  • Day 1
  • Day 2
  • Wednesday, 06 March 2024

    Welcome & Introduction of Trainers and Participants

    Isolator Basics (Theory)

    • Application of isolators
    • Technical basics
    • Components
      • Annex 1
      • Containment/ Cleaning
      • Gloves
      • Ports
      • Process components

    Regulatory View on Annex 1

    Coffee Break

    Relevant Guidelines and Regulations for Gloves

    • PDA Paper

    Gloves on the Isolator (Theory)

    • Requirements for gloves
      • Tightness (pressure, liquid)
      • Insensitivity to media
      • Handling by operator
    • Positioning in the isolator through mock-up studies
    • How do different gloves and design look like
      • Manufacturer
      • Materials

    Lunch Break

    Gloves on the Isolator (Practice)

    • Explanation of technical specification of the isolator
    • Material and design of gloves (different examples)
    • Positioning of gloves in the isolator (various examples)
    • Mock-up study (example)
    • Installation and removal of the gloves
    • Working with/in the gloves on practical examples
      • "easy" example
      • "difficult" example

    Microbiological Monitoring on Gloves (Theory)

    • Swab test - Microbiological testing

    Coffee Break

    Gloves (Practice)

    • Tightness
    • Visual inspection

    Q&A from Day 1

    End of Training Course Day 1 & Networking Event

  • Thursday, 07 March 2024

    Recap Day 1

    Requirements for Environmental Monitoring

    • What are the GMP requirements
    • Find the right position in the isolator system

    Walking through the SKAN Assembly Hall showing examples on large filling lines, small scale filling lines & material transfer systems

    Coffee Break and walk to the Academy

    Practical Training Divided in Group 1 and Group 2

    Get to Know the Isolator (Hall)

    • Doors
    • Gloves
    • Ports/Locks
    • Isolator in operation

    Gloves, Filters and Smoke Studies in Practice (Hall)

    • How does a glove test work?
    • HEPA filter, safe filter change, and test
    • Airflow visualization and studies

    Lunch Break

    Decontamination (Theory)

    • H2O2 as decontaminating agent
      • Properties
      • Concentration
      • Interaction with water
    • Cycle development
      • Validation

    Decontamination (Assembly Hall)

    • Preparation for decontamination
    • Start cycle

    Cleaning SKAN CleanIP (Assembly Hall)

    • What is important to prepare cleaning
    • What is the right method to perform cleaning and how to quantify clean

    Q&A from Day 2

    End of Training Course


Richard  Denk
Richard Denk
Andrew D. Hopkins
Andrew D. Hopkins
AbbVie, Inc.
Andreas Kindscher
Andreas Kindscher
SKAN Germany
Tracy Moore
Tracy Moore
TM Pharma Group Ltd
Richard Mühle
Richard Mühle
SKAN Germany

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course, participants have understood:

    • the different components of an isolator
    • the interactions between the different components

    The participants have learned:

    • the relevant GMP regulations and other guidelines
    • the do's and don'ts in daily operations
    • the basic principles of maintenance, calibration, and validation

    The participants can perform:

    • glove testing
    • handling of settle plates
    • transfer of items in and out of isolator
  • Who Should Attend
    • Operators
    • Manufacturing Supervisors
    • QA Managers

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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.

Skan AG

Kreuzstrasse 5, 4123 Allschwil
Allschwil, Switzerland

Make a Reservation
  • Accommodations

    PDA recommends the reservation at the following hotel

    Holiday Inn Express
    179 Allschwil / Basel

    The hotel is located five minutes walk from the training course venue.

  • Amenities

How to Get Here

By Air

Closest Airport: EuroAirport Basel-Mulhouse-Freiburg

By Car

Skan offers free parking lots at Kreuzstrasse 5, 4123 Allschwil, Switzerland

Other Options

Take bus no. 48 from main station "Basel SBB" to direction Basel Bachgraben and get off at station "Kreuzstrasse". From there, walk 3 minutes along Kreuzstrasse to the new Headquarter of Skan.


Registration Fees

Regular Price
Registration Type Price
All Participants €2.090

* 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.

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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].


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