Modular-Lab eazy

Modular-Lab eazy

A solution for efficient routine production of radiometals

Description

To facilitate the daily work with theranostic tracers, Eckert & Ziegler developed Modular-Lab eazy – the innovative and smallest radiosynthesis system on the market. The synthesizer comes with a completely new cassette design, which makes the handling of Modular-Lab eazy easy.

Key features

Minimal Footprint to safe lab space
High Yield and radiochemical purity
GMP and GAMP5 compliance
Short Synthesis Time to safe time
Disposable Cassettes for routine production
Easy-To-Operate Interface and software
Option to add Multi Elution Tool - able to utilise 3 generators in 1 elution

Detail Information

Functionality

Modular-Lab eazy works with a technology which uses pressure differences to transfer the liquids instead of solenoid valves or stopcocks. The completely new and innovative cassette design makes the handling of Modular-Lab eazy easy. By just clicking in the synthesis cassette all pressure connections are done automatically. After connecting the generator and filling the chemicals, the complete synthesis works without user interaction. The process steps can be monitored via the intuitive user interface. The software is based on the established and reliable Modular-Lab Software complying with the highest standards of GMP (annex 11 for computerized systems), GAMP5, 21 CFR 210/211 cGMP and 21 CFR part 11 regulations.

Cassettes

The sterile, disposable cassettes are equipped with a barcode, which can be read by a barcode reader. This feature helps to support the GMP conform production of radiopharmaceuticals through electronic support of batch reporting and prevention of the incorrect use of cassettes.
The synthesis cassettes are assembled under GMP-compliant clean room conditions and sterilized with gamma-radiation (validated process) according to AAMI TIR33/ISO 11137. It comes with all consumables (no chemicals) which are necessary for the specific synthesis and have been tested for their suitability. Shelf-life is validated for up to 18 months under proper storage conditions.

Disclaimer: Above Manufacturer video is from an offshore website.

Recommendation

To be able to start with the production without any further delay, Eckert & Ziegler offers the all-in-one solution for the synthesis, consisting of the registered GalliaPharm^® 68Ge/⁶⁸Ga Generator, [⁹⁰Y]Yttrium Chloride (Yttriga), disposable synthesis cassettes, quality control devices and a wide range of additional consumables including the Filter Test Module. The peptide has to be purchased by the user.
Users with high demand for ⁶⁸Ga, e.g. when producing tracers with high specific activities, can now be provided with Eckert & Ziegler Eurotope’s Multi Generator Elution Tool for automated elution of up to three ⁶⁸Ge/⁶⁸Ga generators with Modular-Lab eazy.

Publications

2021

Pretze M – Ac-EAZY! Towards GMP-Compliant Module Syntheses of 225Ac-Labeled Peptides for Clinical Application

2020

2018

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Multi Generator Elution Tool

Multi Generator Elution Tool For Modular-Lab eazy

Automated elution of up to three 68Ge/68Ga generators with only one synthesizer.

General Information

The increasing acceptance and demand for 68Gallium for use in the development of diagnostic imaging kits, as well as in actual clinical practice, has highlighted some shortcomings with the existing radiolabeling systems. The trend towards the need for higher activity generators aggravates the potential extremity dose received during manual radiolabeling proto-cols, as well as increasing the incorporated shielding required and therefore the weight of the generators.
In light of these trends, Eckert & Ziegler has developed the Multi Generator Elution Tool. This new tool enables the automated use of eluate from up to three standard (each max. 1.85 GBq/50 mCi) 68Ge/68Ga generators for a single production process with the Modular-Lab eazy system. Sites with high demand for 68Gallium will now be able to combine the required 68Ge activity from one, two or three generators in a single-step procedure. Furthermore, the tool can extend the useful life of each generator by combining eluates.
The Multi Generator Elution Tool updates the current available activity within each of the generators so the user only needs to enter the required amount of activity via the included software tool. The tool automatically calculates the theoretically available activity in each referenced generator, based on the date of its previous elution. The tool furthermore gives recommendation as to which generator(s) should be eluted in order to provide the requested activity. Users can either accept or manually select another option.

Advantages

Flexibility to use low and high activities
Extension of the period of use for each generator by combining eluates of the generators
Opportunity to produce tracers with high specific activities
Multi-dose or various single-doses with high activities - in only one production process
Automatic calculation of which generators have to be eluted and in which order
Possibility to view each generator‘s current acitivity

Technical data
Validated with the following 68Ge/68Ga generators:	GalliaPharm^®, IGG100
Standard time of elution for each 68Ge/68Ga generator:	180 sec. (time is adjustable, depending on the lengh of tubing)
Synthesis time:	with one 68Ge/68Ga generator: < 14 min with two 68Ge/68Ga generators: < 17 min with three 68Ge/68Ga generators: < 19 min
Available for the following applications:	68Ga DOTA- conjugated peptides 68Ga PSMA-HBED 68Ga DOTA-PSMA

Set-Up
Hardware	Stopcock Cassette Module (SLM-1), BUS cable, corresponding software
Consumables	Elution cassette, multiple use / max. 20 elutions (Art. No. C1-GA68-MULTI)
Additional accessories	Waste vial with septum, ≥ 30 mL, multiple use

The end user is solely responsible when using high activities for radiolabeling and should be aware that such high activities might bear the risk of radiolytic decomposition of the tracer after a certain period of time. The use of high activity levels has not been validated for radiolytic effects. No warranty is given by Eckert & Ziegler Eurotope GmbH.