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Daikyo Crystal Zenith Syringes
®
Prefillable Syringes for Biopharmaceutical Drug Products
In 2006 commercial lots of a drug product delivered by an auto-injector that contained a glass prefilled
syringe were recalled in several European countries because of problems with slow or incomplete delivery
of the drug. There was a similar occurrence in 2009 in the United States when an auto-injector batch was
recalled because of high force-to-fire values.
Choice of packaging material can impact a manufacturer’s bottom line now or in the future. By selecting
Daikyo Crystal Zenith syringes made from a novel cyclic olefin polymer, companies may incur a higher
initial investment, but the long-term advantages can far outweigh this outlay.
THE SITUATION
In the current global market, prefilled syringes comprise more than two billion units per year in development and in use. Many chronic diseases, such as
multiple sclerosis and rheumatoid arthritis, require
home-based administration of injectable treatments.
This need has spawned an increased interest in combination drug delivery systems that are safe and convenient, and that help improve the administration process.
Performance Issues – Studies have
shown that silicone oil, used to
increase lubricity in glass syringe
systems, can be distributed unevenly,
leaving surface areas with insufficient
lubrication. This will greatly increase
the force required to operate the autoinjector and may lead to delivery of a
partial dose to the patient.
Auto-injector systems traditionally use 1mL long glass
prefilled syringes. These systems have been successful,
but they have notable limitations, including:
Aggregation – Silicone oil and tungsten residues have been reported to induce protein aggregation in prefilled
syringes.
Breakage – Any glass product runs
the risk of breakage during storage
and shipping. Additionally, glass syringes may break under the pressure
of an auto-injector system.
THE SOLUTION:
The Daikyo Crystal Zenith 1mL Long Insert Needle Syringe System
Daikyo Crystal Zenith (CZ), a cyclic olefin polymer,
possesses many advantageous properties, including
glass-like transparency, which permits visual inspection of the manufactured components and of the parenteral products that are delivered to the end user. In addition, CZ material is highly break resistant and forms
an excellent moisture barrier. Automated clean room
manufacturing and 100% vision inspection ensures extremely low particulate levels.
Daikyo Crystal Zenith prefilled syringes eliminate the
need for silicone oil and do not use tungsten pins that
are commonly used in forming glass syringe barrels.
The CZ insert needle system requires no adhesive to
hold the needle in place in addition to the benefits of no
silicone oil to ensure functionality.
Ideally suited for biopharmaceutical drug delivery, the
CZ syringe is silicone oil-free and laminated with Flurotec® film, which helps to lower protein adsorption and
serves as a barrier to leachable substances. The CZ material’s tight dimensional tolerance and consistency of sy-
ringe functionality can help to make an auto-injector’s
operation predictable – which makes it an easy-to-use,
safe option for the patient.
CZ syringes are available sterile and ready-to-fill with
the same outer dimensions as glass syringes, and manufacturers can incorporate CZ syringes into their filling
lines and secondary devices quickly and cost effectively.
VALUING THE COST OF QUALITY ISSUES
Using a CZ system over an existing glass system will enable you to help prevent:
• Failures of finished drug product (defects during manufacturing process and distribution)
• Internal failures in product development and production
• Defects in the development process that result in lost research time and slower time to market
• Costly preventive action and process improvement
In addition, selecting a CZ system may mitigate risk associated with recalls. Here are anticipated costs over a recall
associated with a glass prefillable syringe system:
Action Associated with
Breakage Issue
1. Recall of glass PFS in autoinjectors
2. Investigation and inspection of
issues, complaints and syringe
products
3. Loss of market share
Associated Costs
2 million units recalled at $500 each
• field complaints enquiry
• investigation and resources
• inspection
Loss of sales until re-launch and loss of 5% of
share at market price post re-launch for year 1
4. Replacement of drug product,
components and delivery systems 2 million units at a cost of $100 each
after re-launch
5. Pipeline Assessment: Drugs in
200,000 units x approx. $100 each as cost
Phase II/III clinical trials
(assuming 1/10 total production)
Mitigating risk with CZ prefillable syringe system, potential savings could be:
Total Cost
Approx. $1 billion
> $50 million
> $50 million
> $200 million
>$2 million
$1˗2 billion
Note: Cost information will vary depending on the specific drug product and market.
Other potential issues including internal quality control issues, finished product rejection, non-conformance issues,
loss of speed to market and lost production/development time can also add to the top line. Clearly, Daikyo Crystal
Zenith syringe systems offer a solution to these issues and many more.
Contact West’s Technical Customer Support at:
North America 1-800-231-3000
Europe +49 (2403) 7960
Asia Pacific +65-6860 5879
www.WestPFSsolutions.com.
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Daikyo Crystal Zenith® and Flurotec® technologies are licensed from Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® and Flurotec® are registered trademarks of Daikyo Seiko, Ltd.
West and the diamond logo are trademarks of West Pharmaceutical Services, Inc.,
in the United States and other jurisdictions.
Copyright © 2011 West Pharmaceutical Services, Inc.
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