PDA EU00152 Test Methods for Pre-Filled Syringe Systems

Gothenburg, Sweden
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Program Highlights

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

Note; In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1-2 weeks in advance. Hard copies of course notes will be no longer provided to participants.

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

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

Standard Pricing

Standard Member Price

€1.895

GovernmentMember Only

€1.895

Health AuthorityMember Only

€1.895

Early Career ProfessionalMember Only

€1.895

StudentMember Only

€1.895

AcademicMember Only

€1.895

Non-Member

€1.895

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Thursday, 19 October 2023


09:00
Welcome


09:00
Introduction to Syringe Systems and Components


10:30 Coffee Break


11:00
Luer Cone and Luer Lock Compliance Testing for Glass and Polymer Syringes

  • Compliance and Connectivity

12:30 Lunch Break

13:30
Requirements for the Empty Sterile Sub-Assembled Syringes Ready for Filling- Part 1

  • Cone Breakage / Flange Breakage / Leakage Testing

15:15 Coffee Break


15:45
Requirements for the Empty Sterile Sub-Assembled Syringes Ready for Filling- Part 2

  • Break Loose and Gliding Force / Needle Testing

16:45
Hands-on Training

  • Test methods described in part 1 & part 2

17:30
Wrap-up of Training Course Day 1


17:45
End of Training Course Day 1

Day 2

Friday, 20 October 2023


09:00
Regulatory Requirements of Finished Pre-Filled Syringes – Part 1

  • Pharmaceutical Characterization / System Characterization / Physical Characterization

10:30 Coffee Break


11:00
Regulatory Requirements of Finished Pre-Filled Syringes – Part 2

  • Pharmaceutical Characterization / System Characterization / Physical Characterization

12:30 Lunch Break

13:30
Upcoming Changes of ISO Standards on Pre-Filled Syringes

  • Empty Sterile Sub-assembled Syringes Ready for Filling
  • Finished Pre-Filled Syringes

14:15
Testing of Syringes for Use in Delivery Devices


15:15
Hands-on Training

  • Test methods described in Part 1 and Part 2

15:30 Coffee Break


16:15
Wrap-up of Training Course Day 2


15:45
End of Training Course

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.

The Swedish Exhibition & Congress Centre - Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden , Sweden

PDA recommends the reservation at the following hotel

Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg,
Sweden

PDA Europe has reserved a limited number of rooms until the 15th August 2023.

Book your room at the PDA Group Rate via the above-mentioned reservation button.


Just a 20-minute walk from the hotel you will find The Garden Society of Gothenburg - one of Europe's best-preserved 19th-century parks. At the other end of town you will find the Botanical Garden, a world-class botanical garden with over 16,000 species to admire.

How to Get Here
By Air Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Korsvägen/Svenska Mässan. They run directly between these stops.
By Car E6 / E20 (from north) and road 45 (from Karlstad): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Take the first exit on the left, turn right onto Örgrytevägen and then take the next exit right towards Svenska Mässan. E6 / E20 (from south) and road 40 (from Borås): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Then take the second exit right towards the hotel.