Modern Polymer Pharma Packaging
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Program Highlights
THIS COURSE IS COMBINED WITH A SITE VISIT AT BAUSCH + LOMBOne of the main challenges in the pharmaceutical industry is selecting the most appropriate primary container system options covering a wide range from traditional glass containers to modern polymer container closure systems. Market segment range from generics to biotech, dosage forms from oral liquids to parenterals. This 2-day training course enables participants to evaluate different packaging systems for liquids and semi-liquids based on formulation properties, market requirements and end-user acceptability. The course is focused on polymer packaging materials and will provide an extensive overview about materials and systems, advantages and limitations. A brief comparison of polymer materials with glass is included in the course, as well as a detailed introduction to blow-fill-seal-technology including container closure integrity testing. Also, the different manufacturing and processes related to the implementation of polymer packaging materials will be discussed. Last but not least, most recent requirements, future trends and innovations in polymer pharmaceutical packaging will be outlined. The course combines classroom lectures with interactive exercises and discussions with experts in this field. The course will be completed with a site visit at a pharma facility, offering a special insight into aseptic blow-fill-seal processing.
Upon completion of this course attendees will be able to
- Develop target profiles for primary pharmaceutical packaging systems for liquids
- Understand modern pharmaceutical packaging technologies, materials, applications and requirements
- Compare different primary container systems with their advantages and limitations
- Understand the specifics of polymer materials used for primary packaging
- Evaluate the characteristics of manufacturing technologies for polymer packaging including blow-fill-seal technology
- Select packaging systems based on the evaluation of market requirements and drug product properties
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Standard Pricing
Standard Member Price
€1.595GovernmentMember Only
€1.595
Health AuthorityMember Only
€1.595
Early Career ProfessionalMember Only
€1.595
StudentMember Only
€1.595
AcademicMember Only
€1.595
Non-Member
€1.595
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
Wednesday, 22 May 2019
9:00
Welcome & Introduction
9:15
Target Product Profile and Container Closure System – From Drug to Packaging and Usability
- Formulation
- Compendial compliance
- Properties e.g. viscosity
- Processability
- Aseptic filling
- Thermal sterilization
- Usability
- User needs
- Administration routes
- Application systems
- Single/multidose
- Environmental conditions
9:55
Primary Container Closure Systems, Part I: Bottles, Vials, Ampules, Cartridges, Syringes
- Requirements
- Advantages and disadvantages
- Overview about available systems
- Glass (bottle, ampoules, vials, cartridges, syringes)
- Polymers (vials, syringes)
10:15
Primary Container Closure Systems, Part II: Blow-Fill-Seal Containers
- Requirements
- Advantages and disadvantages
- Overview about available systems (external sources)
- Bags
- Overview about available systems (internal manufacturing)
- Blow-fill-seal containers
- Bottles
10:35
Coffee Break
10:05
Basics of Blow-Fill-Seal Technology
- From polymer granulates to filled and sealed containers
- Traditional BFS-process
- Multilayer options
11:35
Interactive Exercise 1:
Impact of drug formulation and application on primary packaging and container closure system
12:30
Lunch Break
13:30
Dosage Forms, Designs and Usability of BFS Containers
- Ophthalmics
- Inhalation
- Parenterals
- Terminal sterilization
- User acceptance and usability
- Optimized application of infusions
- Easy empty containers
14:00
Recent Innovations in Blow-Fill-Seal
- Cool-BFS for temperature sensitive formulations
- Increased functions by inserted parts
- Adapters/closures for minimizing administration errors and increasing safety
14:30
Coffee Break
Interactive Session 2:
Impact of drug formulation and application on selection of primary packaging and container closure system and on manufacturing of primary packaging
16:30
Summary Day 1 and Q & A
17:00
End of Day 1
Day 2
Thursday, 23 May 2019
9:00
Primary Packaging Materials, Part I: Glass, Polymers
- Glass
- Glass types
- Basic properties
- Advantages, limitations
- Novel compositions, trends
- Manufacturing
- Tubing
- Converting
- Molding
- Surface treatment
- Polymers
- PE, PP, COP/COP
- Basic properties
- Advantages, limitations
- Trends
- Manufacturing
- Molding
- Surface treatment
9:40
Primary Packaging Materials, Part II: Elastomers
- Elastomers
- Butyl, halobutyl, synthetic polyisoprenes, SBRs
- Basic properties
- Advantages, limitations
- Trends
- Manufacturing
- Surface treatment
10:00
Coffee Break
10:30
Practical Considerations During Development/Selection of Packaging System
- Interaction of packaging materials with drug product
- Closure system
- Impact of storage/transportation temperatures
- Container closure integrity test methods
11:30
Interactive Session 3:
Risk Analysis of material selection (glass or COC/COP) for pre-filled syringes during development of new biopharmaceutical drug product
12:30
Lunch Break
13:15
Bus Transfer to Bausch + Lomb
14:00
Introduction to Facility Tour
- "Virtual" tour through facility: what will be seen
- Different type of BFS technology
- CCIT
- Inspection systems
14:30
Facility Tour at Bausch + Lomb
- BFS machines types in production
- CCIT in operation
- Inspection systems in operation
15:30
Summary Day 1 & 2 and Q & A
16:00
Farewell Coffee
16:30
Transfer to Training Course Hotel
17:00
End of Training Course
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Courtyard by Marriott Berlin City Center
Axel-Springer-Strasse 55Berlin, Germany , Berlin
+49-30-800 928 0
The Courtyard Berlin City Center is situated in the heart of the action, placing you near landmarks like Checkpoint Charlie, Potsdamer Platz, Brandenburg Gate and Alexanderplatz. You'll find it easy to relax in your modern, well-appointed hotel lodging; all of the spacious rooms showcase free high-speed Wi-Fi access, luxurious bedding, an ergonomic desk, a mini-fridge and more. Fuel up for your morning in the Mitte district with a hot breakfast buffet at Oléo Pazzo, or end your day with a delicious Mediterranean meal.
We also provide a fully equipped fitness center, a sauna and an on-site coffee house. Host a meeting or social event with us here in Berlin city center to make use of 8,342 square feet of versatile venue space, cutting-edge event technology and innovative planning and catering. Make the Courtyard Berlin City Center your destination of choice for your visit to the Mitte district.
PDA Europe has reserved a limited number of rooms until the 08th April 2019.
Book Your Room for the PDA Group Rate
Single Room € 135 per night*
Double Room € 150 per night*
*Rates are per room and night, including the following services and benefits free of charge:
- Buffet Breakfast in the restaurant
- usage of Wireless LAN