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TAMPA 2010 CONFERENCE
E05: Managing the Risks and Challenges of Syringe Processing
Nancy St. Laurent, Joerg Zimmermann
Wednesday-Thursday 24-25 February 2010
Tampa, FL
Wednesday, 24 February
Start End Time
Time
7:30
9:00
9:00
9:10
9:10
9:50
Presentation Title
Breakfast
Opening Remarks
Prefilled Syringes: Market overview and Manufacturing Processes (Vetter)
• Introduction to prefilled syringes
• Market overview: volumes worldwide, volumes in the US, EU and rest of the
world
• Products in prefilled syringes
• Market shares bulk and pre-sterilized syringes
• Market shares suppliers
• Processes for bulk and pre-sterilized syringes
• Summary and conclusions
Speaker
St. Laurent
Zimmerman
9:50
10:30
Case Study: Design and Project Planning of a High Speed Syringe Line
(Novartis Vaccines and Diagnostics)
This presentation will include:
- Brief introduction
- History of how Novartis (Holly Springs, NC) increased their US flu cell culture
production capacity to meet market and HHS demand for pandemic flu vaccines
- Equipment features and choices
- Project overview and status
10:30
11:00
11:00
12:00
Networking Break
FDA Syringe Inspections
What are the most common 483’s in relation to processing syringes, from the
filling process through the inspection process? What are companies doing to
correct failures (sterility, mix-ups, etc.)? This session will also present an FDA
perspective on correcting these problems
12:00
13:00
13:00
13:45
Lunch
Martin
Considerations for Developing a Biologic in a Pre-filled Syringe (Pfizer)
This talk will address the following topics:
-The impact of an increased number of product interfaces that are present in prefilled syringe packaging (e.g. silicone, tungsten) vs. traditional vial packaging
-Studies to assess compatibility of biologics with syringe packaging
-The impact of the syringe packaging on processing steps (e.g. silicone, tungsten)
-Functional testing during a stability evaluation
-Other developmental considerations
13:45
14:30
Improved Technical and Design Features in Manufacturing Glass Pre-fillable Drake
Syringes (Nuovo Ompi)
This session presents a new engineering approach, combining high quality glass
forming with innovative features, overcoming most of the limitations still present
with glass PF-syringes. Quality requirements for primary packaging are steadily
increasing following FDA recommendations to reduce any risk of failure and
insure functional performance with delivery and safety devices. One innovation is
to combine glass forming expertise with new design and engineering approaches,
applying these solutions to mass market products for improved glass syringes that
give a broad range of benefits for companies and innovative features for the final
users.
Salisbury
Hirshfield,
PharmD, FDA
14:30
15:00
15:00
15:45
Networking Break
Nikolai
Considerations for Using a Prefilled Syringe in a Delivery Device (Abbott)
This talk will address the following topics:
- Key aspects of the functional requirements for the prefilled syringe
- Siliconization for device robustness
- Systems approaches to the integration of the drug product, primary package and
device
- Automated assembly for commercial operations
- Quality systems and design control
15:45
16:45
Confidential Client Case Studies
Buehler
Stropoli
16:45
17:00
17:00
17:00
Q&A
Seminar Adjourns, Reception
St. Laurent
Thursday, 25 February
Start End Time
Time
Presentation Title
Speaker
7:00
8:00
Breakfast
8:00
8:15
Opening
8:15
9:00
Laser Coding and Reading on Glass Syringe: Latest Developments (Frewitt) Leyvraz
This session will present the latest results on laser coding PF-syringes and will
address the following topics:
- Regulatory issues
- Speed & yield
- Reliability
- Effect on glass and product
- Impact on process
- Cost
9:00
10:00
Bolt
Quality and Technical Considerations for the Manufacturing and Use of
Polymer Syringes (Elanco)
The increased popularity in prefilled polymer syringes has many companies
considering replacing existing final container platforms with this technology which
triggers quality and technical considerations when evaluating and qualifying
polymer syringes. This presentation will provide high level quality requirements
and technical considerations for polymer syringe manufacturing at the syringe
vendor and use in pharmaceutical manufacturing which include: supply, container
closure integrity, sterilization, particulate control, stability, dimensional tolerances,
glide force, inspection and labeling, shipping, common defects, and qualification
activities. While polymer syringes share many of the same requirements and
considerations that apply to glass syringes, the information presented will focus
more on polymer specific manufacturing and use considerations.
10:00
10:30
10:30
11:15
Networking Break
Zimmerman
Developing a Syringe Operation – A Working Case Study
Participants will examine a variety of options for designing and installing a syringe St.Laurent
filling line. Small groups will develop a block flow layout of preferences and would
include some of the following options:
- Bulk syringes versus pre-sterilized
- RABS versus isolator
- Inspection in line or off line
- Marking of individual syringes
- Storage of filled syringes
- Line layouts
- Room layouts
12:00
13:00
13:00
13:45
Lunch
Case Study: Automated Visual Inspection of Prefilled Syringes (Vetter)
• Introduction: manual and automated visual inspection
• Layout/Design of an automated visual inspection machine
• Qualification/Validation approach
• Qualification of the first products: lessons learned
• Routine production / Operation
• Conclusions
Zimmerman
Weikmann
13:45
14:30
Novak
A Challenging Project: Developing and Industrialization of a New
Decontamination Method For Packaging Material. From an Idea to a Solution
(Groninger)
The transfer of contaminated material into a cleaner, mainly an aseptic zone can
be very challenging. Even if bioburden is low, a significant cfu-reduction is
requested and FDA recommends 104 cfu-reduction. Decontamination
technologies in use such as gamma, alcohol spraying, UV, VHP and e-beam are
unlikely to provide a perfect process for reliability (e.g. cfu-reduction at the
complete exterior surface of the secondary packaging), inline processing including
inline inspection (parametric release and 100% check on relevant
decontamination influences), avoiding any site effects (e.g. residuals inside the
primary packaging container or operator / environmental risks), and/or reasonable
costs for investment and operation. Transferring pre-sterilized and nested
syringes from a dirty environment into an aseptic filling zone (Isolator or RABS) is
a very common issue. Therefore we have developed a decontamination chamber
based on plasma-technology. This presentation will show the reasons to start
such a project, the decision options during development, detail the design
qualification, and describe installation and qualification at the customer site by
means of an existing project. Benefits, restrictions and compliance to the named
demands will be discussed openly. A perspective into the next steps, e.g. usage in
the transfer of additional material as bagged objects, will be addressed.
14:30
15:00
15:00
15:45
Networking Break
Characterization of Prefillable Syringe Systems for Biopharmaceutical Drug Young
Delivery (West)
This session will discuss key attributes of a silicone-free prefillable syringe system
including syringe functional performance attributes, ideal for biopharmaceutical
drug delivery applications. Ultra high-quality plastic syringe systems provide a
compelling alternative to glass syringe systems including simplified usage, support
for new classes of biopharmaceutical products, reduced waste, break-resistance,
dosage precision and the virtual elimination of extractables and leachables. These
are attractive benefits for manufacturers seeking new answers to today’s and
tomorrow’s
tomorrow
s drug-delivery and administration challenges. Additionally, rapid growth
of injection devices has become increasing prevalent in pharmaceutical drug
delivery. There is an emerging need to minimize or eliminate protein aggregation
due to silicone oil interaction, reduce contamination due to extractables and
minimize drug loss due to adsorption. Choosing the right injection system can
mitigate these protein aggregation and instability issues.
15:45
16:00
Q&A
16:00
16:00
Seminar Adjourns
***Please note that agendas are subject to change***
Zimmerman
St.Laurent