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PDA EU00157 Understanding Sterilization

Jun 28 - Jun 30, 2022
Albuzzano, Italy

  • Education
  • Europe
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Program Highlights

The course will be held at Fedegari’s Tech Center, where participants will be able to discuss real-life problems while using Fedegari equipment to apply their new knowledge and capabilities.

Overview

Three days fully dedicated to every sterilization aspect, from basic principles to validation activities. Starting from an overview of all sterilization methods, participants will have the opportunity to discover the secrets of moist-heat sterilization. Not only theoretical sessions, but also hands-on training with process machines for increasing your practical knowledge.

The course will be held at Fedegari’s Tech Center, where participants will be able to discuss real-life problems while using Fedegari equipment to apply their new knowledge and capabilities. Finally, attendees will have the opportunity to share their experiences and challenges with experts in sterilization and contamination control.

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Agenda

  • Day 1
  • Day 2
  • Day 3

  • Tuesday, 28 June 2022

    9:00
    Introduction to Current Decontamination Methods

    • Distinguish disinfection, sterilization and decontamination
    • E- Beam
    • EtO
    10:30
    Coffee Break

    11:00
    Introduction to Current Decontamination Methods (cont.)

    • ɤ-Irradiation
    • Hydrogen Peroxide: Principle and application in Pharma, Equipment
    • Regulations
    12:30
    Lunch Break

    13:30
    Plant Tour

    14:30
    Coffee Break

    14:45
    Hydrogen Peroxide Decontamination in Practice

    • Group session with practical examples of correct / wrong cycles
    • Correct placement of probes and indicators for various load types

    17:30
    End of Day 1

  • Wednesday, 29 June 2022

    8:30
    Wrap-up of Day 1 and Questions

    9:00
    Moist-heat Sterilization Principles

    • Sterility assurance concept (PNSU or SAL), D-values, z-values, F0
    10:30
    Coffee Break

    11:00
    Moist-heat Sterilization, Load Types and Process/ Autoclave Selection

    • Steam sterilization: general concepts
    • Case studies
    12:30
    Lunch Break

    13:30
    Moist-heat Sterilization, Load Types and Process/ Autoclave Selection

    • Counterpressure cycles
    • Case studies
    15:30
    Coffee Break

    15:45
    Practical session: How to create the right cycle for a specific load

    16:45
    Q&A Session

    17:00
    End of Day 2

  • Thursday, 30 June 2022

    8:30
    Wrap-up of Day 2 and Questions

    9:00
    Biological Indicators and Validation – Parametric Release

    10:30
    Coffee Break

    11:00
    Temperature Mapping and Practical Sessions Common Loads

    12:30
    Lunch Break

    13:30
    Routinely and Operational Tests

    • Vacuum and pressure leak test
    • Bowie & Dick test
    • Equilibration time
    • Steam quality test
    15:30
    Coffee Break

    15:45
    New Annex 1 Revision - What Changes for Sterilization?

    16:00
    How Can the New Annex 1 Leverage Technology Innovation in Pharma?

    17:00
    Q&A Session

    17:30
    End of Day 3

Additional Information

  • Learning Objectives

    Learning Objectives

    The participants:

    • Have understood concepts of decontamination, disinfection and sterilization
    • Have understood the principles of moist heat/dry heat sterilization
    • Have an overview of other sterilization methods (gamma irradiation, E-Beam, EtO)
    • Can calculate F and D values
    • Have understood the different cycle requirements for various load types (solid, porous, liquid)
    • Have understood approaches for qualification of equipment
    • Have understood challenges and solutions for biological and chemical indicators
  • Why Attend

    Why Attend

    Attendees will learn how to:

    • Create the perfect cycle for liquid and porous loads
    • Run biological and thermal validation
  • Who Should Attend

    Who Should Attend

    • Manufacturing Supervisors and Operators
    • QA Managers
    • QC Managers
    • Facility Managers/Technicians
    • Validation/Qualification Personnel
    • Equipment Manufacturers
    • Head of Production
    • Process Engineers
    • Process Developers

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Travel

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Fedegari Autoclavi s.p.a.

SS 235 km 8
Albuzzano, Italy

Fedegari Autoclavi s.p.a.
  • Accommodations

    Training Location

    Fedegari Group
    Fedegari Autoclavi s.p.a.
    SS 235 km 8
    27010 Albuzzano (PV), Italy

  • Amenities

How to Get Here

By Air

Nearest Airport: Linate Airport – LIN

By Car

Transfer per Taxi to the Training Location
Distance: 52 km
Duration: 43 min
Estimated Fee: 95 Euros

Other Options

Transfer per Trains and Bus to the Training Location
Direction: 52 km
Duration: 2h 40 min
Estimated Fee: Check upon arrival at the airport

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 2.345

All fees given in Euro and excluding VAT

* 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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Contact

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Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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