PDA EU00180 Manage Your Isolator for Aseptic Processing

Allschwil, Switzerland
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Program Highlights
An additional highlight is the joint dinner at the end of the first training course day, where participants and trainers can get to know each other better and expand their network. Don't miss this unique opportunity and reserve the evening for this get-together.

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.

Who Should Attend
  • Operators
  • Manufacturing Supervisors
  • QA Managers
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

More information coming soon.


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

Wednesday, 19 February 2025

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

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

Coffee Break

Gloves on the Isolator(Practice)

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

Q&A from Day 1

End of Training Course Day 1 & Networking Event

Day 2

Thursday, 20 February 2025

Recap Day 1

Microbiological Monitoring on Gloves (Theory)

  • Swab test - Microbiological testing

Gloves (Practice)

  • Tightness
  • Visual inspection

Coffee Break

Requirements for Environmental Monitoring

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

Lunch Break

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

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

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.

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.

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