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2023 PDA_Training-1988x680

PDA EU00187 Characteristics of Pharmaceutical Elastomers in Parenteral Packaging Systems

Oct 19, 2023
Gothenburg, Sweden

  • Education
  • Europe
Cancelled

Overview

Pharmaceutical elastomers are commonly applied in the form of stoppers, plungers, and O-rings for parenteral drug-delivery applications. Here, good sealing is an apparent property for effective drug containment; however, there are several other critical attributes that govern the selection of an appropriate elastomeric component for safe and efficacious drug-delivery.

In this one-day training course, you will gain insight into the fundamentals of pharmaceutical elastomers with practical considerations. Industry experts will describe component selection strategies, review manufacturing technologies, component processing and sterilization techniques. There will be a focus to understand the origin of defects and analytical tools applied for their characterization.

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Agenda

  • Thursday, 19 October 2023

    09:00 Welcome and Collection of Participant's Expectations

    09:15 Introduction to Container Closure Systems

    • Vials, PFS, Cartridges with a focus on elastomeric and aluminum components

    09:30 Introduction to Pharmaceutical Elastomers

    • Selection criteria and key considerations
    • Physical and chemical properties
    • Applications, variations, and functionalities
    • E/L profiles

    10:30 Coffee Break

    11:00 Pharmaceutical Elastomer Manufacturing Process

    • Manufacturing technologies
    • Understanding critical manufacturing parameters

    11:45 Processing of Elastomeric Components

    • Fundamentals of RFS and RTU components
    • Importance of siliconization and selection criteria
    • Basics of camera inspection
    • Sterilization choices and elastomer packaging selection

    12:45 Lunch Break

    13:45 Elastomeric Testing

    • Understanding origin of defects
    • Defect classification (discussion of PDA TR76 report)
    • Commonly applied analytical methods
    • Test methods discussion – for eg. CCI, silicone, moisture retention, chemical identification

    14:45 Coffee Break

    15:15 Regulatory Requirements Applicable to Elastomeric Closures

    • Pharmacopoeia requirements for elastomers and aluminum seals 
    • Recent changes / updates in USP <381> and PH. Eur. 3.2.9.
    • FDA requirements & post approval changes for container closure system / components 
    • Recent EU regulations on primary packaging 

    16:30 Q&A and Summary

    17:00 End of Training Course Day

Trainers

Elke Geuzens
Elke Geuzens
Datwyler
Bio
Elke Geuzens
Datwyler

Elke Geuzens graduated with a doctorate in chemistry from Hasselt University, Belgium. Before she joined Datwyler in 2010 as a product support manager, she had several years of experience in the chemical industry. Currently, Elke is a technical key account manager and she has more than 10 years of experience in similar roles within the company.

In her current role, Elke consults with pharmaceutical and medical device companies on parenteral packaging solutions to develop safe and efficacious drug-delivery systems. She holds global responsibility for several key clients, where she is responsible for technical projects from the ideation to the commercialization stage.

Peter Loyen
Peter Loyen
Datwyler
Bio
Peter Loyen
Datwyler

Peter Loyen holds a Bachelor degree in Electronics. After working in the Automotive industry, he joined Datwyler in 1994. Peter has over plus 20 years of experience within Datwyler in multiple positions. In 2017, Peter became Technical Key Account Manager, supporting the profitable growth of Datwyler Healthcare through demonstrating industry-leading Technical Expertise inside and outside the Datwyler organization.
Tabassam Sharif
Tabassam Sharif
Datwyler
Bio
Tabassam Sharif
Datwyler

Tabassam Sharif has been with Datwyler since 2018 and is currently a Manager of Regulatory Affairs. He has a Master’s degree in natural sciences and has worked within the Regulatory Affairs discipline of the pharma industry for 15 years. In his current role, Tabassam holds global responsibility for submission and update of Drug Master Files with the health authorities in order to support pharma companies in seeking regulatory approvals. He is also a member of several standardization groups, such as the Ph. Eur. experts Group 16, ISO Technical Committee 76 / WG4, and PDA Task Force on TR 73-2.

Additional Information

  • Learning Objectives

    Learning Objectives

    • 1. Select an appropriate packaging container for drug delivery with a focus on elastomers and lined aluminum seals
    • 2. Explain the science and manufacturing principles behind elastomers for pharmaceutical packaging
    • 3. Evaluate the critical processing parameters that determines if RFS or RTU
    • 4. Discuss the evolution in the regulations that govern elastomeric closures
    • 5. Describe best practices in primary packaging selection
  • Who Should Attend

    This training course is intended for professionals who are responsible for primary packaging components for pharmaceutical containers.

    Departments

    Quality Control, Quality Systems, Engineering, Manufacturing, Quality Assurance Operations, Research and Development, Regulatory Affairs, Technical Operations, Packaging, Formulation Scientist

    Roles

    Analyst, Specialist, Supervisor, Manager, Director, Engineer, Scientist

     

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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.

Mässans Gata 24
Gothenburg, Sweden

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  • Accommodations

    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.

    For group requests over 6 bedrooms please send an email to [email protected]

    Attn. Emelie Sandell

  • Amenities

    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.

Other Options

From the main railway station take the number 2 tram (towards Krokslätt) or the 4 (towards Mölndal). From Brunnsparken Square you can also take the number 5 tram (towards Torp). The trams stop at Korsvägen / Svenska Mässan. Tram timetables can be found on the Västtrafik website.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 1.055

* 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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