Introduction

To succeed in a challenging and fluctuating marketplace, PET tracer distribution centers need the capacity to meet varying demand in the most economical way. To meet the variable day-to-day demands of PET imaging, clinical PET centers need reliable, efficient output, with minimal disruption and errors. 

 

To learn more and see the FASTlab 2 and FDG Duo cassettes in action, watch this video.


FASTlab 2 and FDG Duo can optimize your PET tracer production workflow: 

• Optimized hot cell output 
• Effective PET tracer economics 
• Compliance and safety as standard 
• Flexibility and range 
• Working with GE Healthcare

 

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Optimized Output

Achieve more from your hot cell space, synthesizer capacity and staff time to ensure you have the versatility of output to meet varying day-to-day demand. Maximize the capacity and versatility of your hot cell output. 

 

The new design of FASTlab 2 allows: 

• Two synthesizers to be stacked into a single standard hot cell (a), giving greater output and saving lab space (b)

• FDG Duo cassettes to offer up to four FDG citrate runs in a single hot cell without having to open the hot cell door, helping you optimize your hot cell

• Running of FDG or alternative PET tracers in combinations, maximizing versatility and diversification

• More doses from a single setup and operator work flow (b), leading to better demand planning and responsiveness

• Electronics to be protected from radiation and facilitated maintenance access, improving reliability by design ensuring minimal maintenance down time

 

 

Note: FDG Duo cassettes only run on the FASTlab 2 platform. All other GE Healthcare Multi-Tracer cassettes run on both FASTlab and FASTlab 2 platforms. FDG Duo cassettes are only available in citrate formulation, not in phosphate formulation.

 

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Economics

Effective PET Tracer Economics

The assurance of rapidly available and high quality FDG leads to better economics and allows you to focus on developing other areas of your PET tracer facility. High and reproducible yields ensure confidence in FDG supply.

GE Healthcare FDG Duo cassettes are preloaded with reagents, allowing you to perform two consecutive FDG citrate runs using only one cassette without having to open the hot cell door between runs.

FDG Duo cassettes are of equivalent quality and performance to GE Healthcare FDG citrate cassettes, with high and reproducible yields ensures confidence in FDG supply. (Typically >70% uncorrected yield). 

 

 

Note: FDG Duo cassettes only run on the FASTlab 2 platform. All other GE Healthcare Multi-Tracer cassettes run on both FASTlab and FASTlab 2 platforms. FDG Duo cassettes are only available in citrate formulation, not in phosphate formulation.

 

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Compliance and Safety

FASTlab 2 facilitates quality and regulatory processes, with optimal operator safety throughout. 

GE Multi-Tracer cassettes help you reduce costs and save time in your quality and regulatory processes:

• Manufactured in a controlled environment

• Fully integrated, preloaded and validated by GE1

• One consolidated Certificate of Analysis for all components and reagents

• “Plug and Produce” cassettes arrive ready for use

GE Healthcare provides regulatory support documentation for the FASTlab 2, GE Multi-Tracer cassettes and synthesis processes.

Each GE Healthcare Multi-Tracer cassette is identified using an RFID tag including batch and expiry date information to ensure the correct cassette is used for each tracer, reducing human error and improving traceability.

An optimized workflow also maximizes operator safety, because FASTlab 2 and FDG Duo can give you more output from your hot cell without having to open the door.

  

Additional safety functionality provides further protection for operators

 

 

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  1. A GE Healthcare standard for all GE cassettes.

Flexibility and Range

Satisfying varied demand with the capability to produce a full range of desired tracers on one system and the functionality to develop new tracers. 

FASTlab 2 has three levels of licensing enabling you to access the range of tracers you desire:

• FASTlab 2 Multi–Tracer – GMP production of key tracers

• FASTlab 2 Tracer–Alliance – Access to new tracers developed by partners

• FASTlab 2 Developer (b) – Develop and produce your own tracers

 

FASTlab 2 Tracer-Alliance

Use additional tracer applications from third party vendors (Note 3).

Share and produce tracers that have been developed using FASTlab 2 Developer with multiple sites – facilitating multi-center studies and pharmaceutical trials.

 

Note 1: Tracer-Alliance license includes Multi-Tracer license. Developer license includes Tracer-Alliance and Multi-Tracer licenses. 

Note 2: Customers should gain US Food and Drug Administration (FDA) approval for their tracers. FDA approval has been given for FDG and NaF tracers. Outside US approval depends on local regulation. FMISO and FLT are investigational agents not yet approved by regulatory authorities.

 (b) Special terms and conditions apply for FASTlab 2 Developer

Note 3: GE Healthcare has no liability for third-party products. GE Healthcare is not responsible for the availability of these tracer applications.

 

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Tech Specs


 

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