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Parenteral Drug Association Connecting People, Science and Regulation ®

Understanding Sterilization

Feb 26 - Feb 28, 2019 |
Feb 28, 2019 |
Fedegari Autoclavi s.p.a. | Albuzzano, Italy
  • Education
  • Europe
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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.

Attendees will learn how to

  • Select the right machine according to the product to be treated
  • Create the perfect cycle for liquid and porous loads
  • Run biological and thermal validation

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

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

Instructors

Maria Luisa Bernuzzi, Manager R&D, Fedegari Group
Graduated from University (Chemistry and Pharmaceutical Technology) at the University of Pavia, Maria Luisa started her career dealing with environmental analyses, and then moved to Chemical - Pharmaceutical industry. Being R&D manager and QC manager, in 2010, she also attended a Master degree about “Evaluation and control of the toxicological risk from environmental pollutants - legislation REACH, CLP - chemical risk assessment”. Since 2011, Maria Luisa is R & D manager at Fedegari group: new technologies, a multidisciplinary approach at the Innovations, development of validation strategies ad assessment of process efficacy, also with microbiological tests, are her main tasks. Specialties: Validation of equipment, Sterilization processes, Isolation technology in aseptic and containment applications, Decontamination.


Darren Beckett, Technical Director, Steritech Ltd
Darren Beckett is the Technical Director for SteriTech Ltd. SteriTech are the partner company for Fedegari and Masco Groups in the UK and Ireland. Darren heads the technical team responsible for support, training and consultancy focused on washing, sterilisation and associated aseptic processes including cycle development and validation activities. Darren has over 20 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry focusing on commissioning and validation of moist and dry heat sterilisers and critical utility systems. Since 2013, he has managed the technical centre which includes client product R&D and process development/validation projects and acts as the principle technical and process trainer both at our technical centre and at customer’s sites across Europe and the US.

Tuesday, 26 February 2019

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, 27 February 2019

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, 28 February 2019

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
Variables Affecting Validation


16:15
Q&A Session


16:45
End of Day 3

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entitled to receive a discount? Need Help?

Day 1 + 2: Sterilization Overview and Practice

1.595 Euro

Day 3: Validation and Qualification

895 Euro

Day 1 + 2 + 3: Sterilization – All You Need to Know

2.345 Euro

All fees given in Euro and excluding VAT (22%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Training Location

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

Sponsorship and Exhibit Opportunities are not Available!

Register Now
https://www.pda.org/docs/default-source/website-document-library/eu-education/2019/02_understanding-sterilization/registration-form.pdf

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