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PDA EU00172 Manage Your Isolator for Aseptic Processing

Nov 10 - Nov 11, 2021
4123 Allschwil , Switzerland

  • Education
  • Europe

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Overview

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

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

Agenda

  • Day 1
  • Day 2
  • Wednesday, 10 November 2021

    9:00

    Welcome & Introduction of Participants


    9:30

    Insulator Basics

    • Application of Isolators
    • Technical basics
    • Components
      • Annex 1 (review of Annex 1 Draft)
      • Containment/ Cleaning
      • Gloves
      • Ports
      • Process components


    10:45

    Coffee Break


    11:15

    HVAC System & Laminar Airflow

    • HEPA-Filter
    • Impact of process equipment and process steps on airflow
    • Smoke studies


    12:15

    Lunch Break


    13:15

    Get to Know the Isolator

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


    14:15

    Smoke Studies in Practice

    • Smoke generator
    • Visualisation of airflow
    • Documentation/Video taping


    15:00

    Coffee Break


    15:30

    Decontamination

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


    16:30

    Decontamination

    • Preparation for decontamination
    • Start cycle


    17:30

    End of Day 1

  • Thursday, 11 November 2021

    09:00

    Recap Day 1


    09:15

    Relevant Guidelines and Regulations for Gloves

    • PDA Paper


    10:15

    Gloves on the Isolator

    • 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


      10:45

      Coffee Break


      11:15

      Gloves on the Isolator

      • 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


      12:15

      Microbiological Monitoring on Gloves (Theory)

      • Swab test


      13:00

      Lunch Break


      14:00

      Gloves

      • Tightness
      • Visual inspection
      • Microbiological testing


      14:30

      Coffee Break


      15:00

      Gloves (cont.)


      15:30

      Recap and Quiz


      16:15

      End of Course

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

    Who Should Attend

    • Operators
    • Manufacturing Supervisors
    • QA Managers

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Travel

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Skan AG

Kreuzstrasse 5
4123 Allschwil , Switzerland

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

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.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1795

* 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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