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.

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

Standard Pricing

Standard 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. registration-europe@pda.org

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 registration-europe@pda.org 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, 06 March 2024

8:30
Welcome & Introduction of Trainers and Participants

9:00
Isolator Basics (Theory)

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

9:45
Regulatory View on Annex 1

10:20
Coffee Break

10:50
Relevant Guidelines and Regulations for Gloves

  • PDA Paper

11:20
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

12:30
Lunch Break

13:15
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

15:00
Coffee Break

15:30
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"

17:00
Q&A from Day 1

17:30
End of Training Course Day 1 & Networking Event

Day 2

Thursday, 07 March 2024

09:00
Recap Day 1

09:05
Microbiological Monitoring on Gloves (Theory)

  • Swab test - Microbiological testing

10:05
Gloves (Practice)

  • Tightness
  • Visual inspection

11:05
Coffee Break

11.30
Requirements for Environmental Monitoring

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

12:15
Lunch Break

13:15
Walking through the SKAN Assembly Hall showing examples on large filling lines, small scale filling lines & material transfer systems

14:00
Decontamination (Theory)

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

14:30
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

16:30
Q&A from Day 2

16:45
End of Training Course

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
Hegenheimermattweg
179 Allschwil / Basel
Switzerland

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