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PDA EU00152 Test Methods for Pre-filled Syringe Systems

May 18 - May 19, 2022
Dublin, Ireland

  • Education
  • Europe

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Program Highlights

The participants of this course will benefit from first hand information of the instructor based on practical experience.


The course will be an interactive lecture around Pre-filled Syringe Systems including ISO compliance testing. The participants will benefit from first hand information of the instructor based on practical experience. The lecture includes the life cycle of a PFS from the idea to the finished marketed product.


  • Day 1
  • Day 2
  • Wednesday, 18 May 2022


    Introduction to Syringe Systems and Components

    Coffee Break

    Luer cone and Luer lock Compliance Testing for Glass and Polymer Syringes

    • Compliance and Connectivity

    Lunch Break

    Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 1

    • Cone Breakage / Flange Breakage / Leakage Testing

    Coffee Break

    Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 2

    • Break Loose and Gliding Force / Needle Testing

    Hands-on Training

    • Test methods described in part 1 & part 2

    Wrap-up of Day 1

    End of Day 1

  • Thursday, 19 May 2022

    Regulatory Requirements of Finished Pre-filled Syringes – Part 1

    • Pharmaceutical Characterization / System Characterization / Physical Characterization

    Coffee Break

    Regulatory Requirements of Finished Pre-filled Syringes – Part 2

    • Pharmaceutical Characterization / System Characterization / Physical Characterization

    Lunch Break

    Upcoming Changes of ISO Standards on Prefilled Syringes

    • Empty Sterile Sub-assembled Syringes Ready for Filling
    • Finished Prefilled Syringes

    Testing of Syringes for Use in Delivery Devices

    Hands-on Training

    • Test methods described in part 1 & part 2

    Coffee Break

    Wrap-up of Day 2

    End of Training Course


Horst Koller
Horst Koller
HK Packaging Consulting GmbH

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course the participants will have solid knowledge of

    • Materials used for PFS Systems
    • Luer Cone and Luer Lock Compliance Testing
    • Requirements for the empty sterile sub-assembled syringe ready for filling
    • Test Methods for Drug Product Filled Syringes
    • PFS used in Delivery Systems
  • Who Should Attend

    The course is designed specifically for those who are involved or interested in the development, manufacturing and QC-testing of a Pre-filled Syringe System:

    • Engineers and Managers in Device Development and all other technical functions surrounding syringe systems
    • Manufacturing Supervisors
    • Quality Personal / Regulatory Personal
    • Clinical and commercial Drug Product Manufacturing

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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

Northwood Park
Dublin, Ireland

Crowne Plaza Dublin Airport
  • Accommodations

    Carlton Hotel Dublin Airport

    Old Airport Rd, Cloghran,
    Dublin, K67 P5C7,
    Tel: +353 1 866 7500 

  • Amenities

    The Carlton Hotel Dublin Airport is a 4-star modern boutique hotel, located just off the M1 & M50 motorways, only 4 minute’s drive from the conference venue Crowne Plaza Dublin Airport. The hotel provides a 24-hour shuttle bus service to and from the airport for all guests as well as ample on-site parking.

    There will be also a shuttle service provide from the conference venue to the Carlton hotel in the morning as well after the end of the conference.

How to Get Here

By Air

The Crowne Plaza Dublin Airport is 3 km away from Dublin International Airport

By Car

The Crowne Plaza Dublin Northwood is set in parkland, close to highways M1 and M50, and 15 minutes from central Dublin. At Crowne Plaza Dublin Airport, self-parking is available for a daily rate of 6 EUR.

Other Options

The nearest train station is Connolly Station


Registration Fees

Regular Price
Registration Type Price
All Participants €1.795

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.

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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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