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Achieve milestones faster with an integrated, verified prefillable syringe system
A prefillable syringe is considered a device constituent part of a final combination product and is prefilled with a medication or drug product in a sterile filling environment. West Synchrony S1 PFS system is an innovative platform that uniquely integrates the syringe barrel, plunger, and needle shield/tip cap into a fully harmonized, verified system from a single supplier.
Why you can't design your Prefillable Syringe System out of components
Leaders in drug development face pressures to meet milestones efficiently amid complex challenges, amongst them, selecting prefillable syringes. Companies currently rely on fragmented approaches—assembling component data from multiple suppliers or outsourcing piecemeal verification—which risks delays, increased costs, and regulatory setbacks. With West Synchrony S1 Prefillable Syringe (PFS) System, you can accelerate syringe system selection, streamline global regulatory submissions, and secure a reliable, flexible supply chain that meets quality and volume needs.
Why you can't design your Prefillable Syringe System out of components
De-risk combination product development and meet milestones with confidence
1
System-level Performance
Utilize a single verification data package inclusive of all drug-independent testing to freeze your device part design earlier.
2
Comprehensive Regulatory Submission
Reduce the time and effort needed to achieve regulatory approval around the globe with our regulatory package.
3
Streamlined Supply for Your Entire PFS System
Enable flexible, demand-driven sourcing for your PFS system in the quantity and quality that you need.
The FlexQTY stock keeping units (SKU) are ideal for smaller volume needs, supporting early-stage activities such as initial system testing, engineering runs, and early clinical fills. These SKUs do not include tailgate samples for the plunger or the syringe barrel assemblies.
Make-to-stock signature system options: 1 ml long staked needle, 27 or 29 gauge, thin wall, small round flange and a rigid needle shield with either a 1 ml NovaPure plunger 1 ml FluroTec plunger
1 Port Bag of Plungers
5 Syringe Barrel Assembly Cartons
The packaging configuration and number of systems varies depending on your syringe system selection and tub configuration.
Nest Size
SBAs per Tub
Number of Tubs per Carton
Number of Cartons per Pallet
Number of Pallets
Number of Systems
FlexQTY
10 x 10
100
15
5
1
7,500
FlexQTY
10 x 16
160
15
5
1
12,000
The StdQTY stock keeping units (SKU) are designed to accommodate larger order volumes and supports scaling from clinical to full production runs. These SKUs include tailgates for plungers, with the quantity of plungers per tailgate varying by SKU. Tailgates are not included for syringe barrel assemblies.
Make-to-stock signature system options: 1 ml long staked needle, 27 or 29 gauge, thin wall, small round flange and a rigid needle shield with either a 1 ml NovaPure plunger 1 ml FluroTec plunger
3-4 Port Bags of Plungers
Plunger Tailgate
20 Syringe Barrel Assembly Cartons (on 2 pallets)
The packaging configuration and number of systems varies depending on your syringe system selection and tub configuration.
Nest Size
SBAs per Tub
Number of Tubs per Carton
Number of Cartons per Pallet
Number of Pallets
Number of Systems
StdQTY
10 x 10
100
15
10
2
30,000
StdQTY
10 x 16
160
15
10
2
48,000
FlexQTY™
12,000 systems
The FlexQTY stock keeping units (SKU) are ideal for smaller volume needs, supporting early-stage activities such as initial system testing, engineering runs, and early clinical fills. These SKUs do not include tailgate samples for the plunger or the syringe barrel assemblies.
Make-to-stock signature system options: 1 ml long staked needle, 27 or 29 gauge, thin wall, small round flange and a rigid needle shield with either a 1 ml NovaPure plunger 1 ml FluroTec plunger
A
B
1 Port Bag of Plungers
5 Syringe Barrel Assembly Cartons
The packaging configuration and number of systems varies depending on your syringe system selection and tub configuration.
Nest Size
SBAs per Tub
Number of Tubs per Carton
Number of Cartons per Pallet
Number of Pallets
Number of Systems
FlexQTY
10 x 10
100
15
5
1
7,500
FlexQTY
10 x 16
160
15
5
1
12,000
StdQTY™
48,000 systems
The StdQTY stock keeping units (SKU) are designed to accommodate larger order volumes and supports scaling from clinical to full production runs. These SKUs include tailgates for plungers, with the quantity of plungers per tailgate varying by SKU. Tailgates are not included for syringe barrel assemblies.
Make-to-stock signature system options: 1 ml long staked needle, 27 or 29 gauge, thin wall, small round flange and a rigid needle shield with either a 1 ml NovaPure plunger 1 ml FluroTec plunger
A
B
C
3-4 Port Bags of Plungers
Plunger Tailgate
20 Syringe Barrel Assembly Cartons
The packaging configuration and number of systems varies depending on your syringe system selection and tub configuration.
Nest Size
SBAs per Tub
Number of Tubs per Carton
Number of Cartons per Pallet
Number of Pallets
Number of Systems
StdQTY
10 x 10
100
15
10
2
30,000
StdQTY
10 x 16
160
15
10
2
48,000
Related Content
Blog
Selecting a Prefillable Syringe System with Confidence Q&A
West Synchrony S1 prefillable syringe (PFS) system is an innovative platform designed specifically for biologics and vaccines that uniquely integrates the syringe barrel, plunger, and needle shield/tip cap into a fully harmonized, verified system from a single supplier. To learn how to evaluate and select a PFS system with confidence, see our Prefillable Syringe System Selection Q&A.
West Synchrony S1 PFS system sets a new standard in drug delivery by accelerating syringe selection through its system-level verification data and regulatory data packages. This new approach enables pharmaceutical companies to streamline design, accelerate regulatory submission, and secure a reliable supply chain for combination products that meet quality and volume needs. To learn more, download our infographic on accelerating drug development timelines.
The West Synchrony S1 PFS system portfolio offers 1 ml long, 1 ml standard, and 2.25 ml syringe system sizes in both staked needle and Luer lock options. Staked needle system configurations may have either a 25, 27, or 29 gauge, depending on the size of the syringe barrel. 1 ml long and 2.25 ml staked needle system options have a ½ inch, 5-bevel needle, while the 1 ml standard has a 5/8 inch, 5-bevel needle.
Customers can select from small round, large round, or cut flanges to support ergonomic use or device integration. The shape of the flange will also depend on the selected syringe barrel. Needle shields can be rigid or soft, while all Luer lock system options will all have an integrated tip cap.
All West Synchrony S1 PFS system options come with either a NovaPure® plunger, a plunger with FluroTec® barrier film, or an unlaminated plunger and undergo the Envision® Verification Process to proactively detect contamination, defects, and particulates.
There is much guidance and regulation out there, but at a minimum ISO 11040-8 and USP <382> for performance, ISO 10993 and USP 87 for biocompatibility, USP 1663, ICH Q3D & Q3E for extractables, USP 1664 for leachables, and USP 1207 for container closure integrity are applicable to PFS combination products. West has completed biocompatibility, extractable, and performance testing for West Synchrony S1 PFS system. Leachables must be run by the drug manufacturer. See how West Vantage™ Regulatory Services help you align both from early development through approval for your combination products.
West Synchrony, NovaPure, FluroTec, FlexQTY and StdQTY are trademarks or registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
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