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PDA EU00172 Manage Your Isolator for Aseptic Processing

Nov 09 - Nov 10, 2021
4123 Allschwil ,

  • 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.

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Agenda

  • Day 1
  • Day 2

  • Tuesday, 9 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

  • Wednesday, 10 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

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.

Crowne Plaza Dublin Airport

Kreuzstrasse 5
4123 Allschwil ,

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.

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].

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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