Class A
gmp
Tailor-made solutions designed around your needs.
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Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
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Comprehensive support throughout the entire project lifecycle.
Discover our services
Comprehensive support throughout the entire project lifecycle.
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Insights, Events and Technical Content from Tema Sinergie
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Insights, Events and Technical Content from Tema Sinergie
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Discover more about the Tema Sinergie Group and its international presence.
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Discover more about the Tema Sinergie Group and its international presence.
Learn more about the CompanyDiscover more about the Tema Sinergie Group and its international presence.
Learn more about the Company
Discover more about the Tema Sinergie Group and its international presence.
Learn more about the Company
Discover more about the Tema Sinergie Group and its international presence.
Learn more about the CompanyNEXT
NEXT is an automatic dispenser for vials and syringes that incorporates a Class A non-shielded pharmaceutical isolator (ISO 5), equipped with a Class B (ISO 6) side antechamber for the safe introduction of sterile materials, and a compact, high-precision, self-shielded dispenser for filling vials and syringes.
Designed and Manufactured by Tema Sinergie
gmp
ISO 10648:2
Overview
NEXT revolutionizes the standard configuration of dispensing systems in radiopharmacy: it integrates a shielded dispenser into an unshielded isolator designed for pharmaceutical use.
A compact solution for the automatic filling of vials and syringes, combining lightweight design, precision, aseptic processing, and radiation protection.
With NEXT, the floor load capacity is no longer a limitation.
NEXT includes a dispenser for syringes and vials, whether open or closed.
It uses the same set of consumables with different types of containers, allowing for the continuous filling of vials and syringes.
Compliance with GMP and the maintenance of an aseptic process are fundamental requirements of the entire system. The parameters of the VHP cycle ensure the effectiveness of the decontamination and sterilization processes.
The lead shielding core surrounds only the dispensing system. This configuration reduces the system’s overall weight, making it easier to handle and install and minimizing the load on the floor.
NEXT enables the creation of reports and statistics using dedicated software that is fully compliant with FDA 21 CFR Part 11, ensuring the traceability and integrity of operational production data.
Next consists of:

Robotic arm with built-in gripper for both vials and syringes
Dispensing filter integrity test
Dispensing system for vials and syringes
Integrated dose meter
1 single-batch kit with a 0.22 µm filter
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Class A main chamber with laminar flow: vertical, across the entire surface of the chamber; horizontal, limited to the nozzle shielding area
Class B pre-chamber with turbulent flow
Integrated dose calibrators
2 shielded compartments for liquid and solid waste
1 video camera
Inflatable seals to ensure Class II airtightness (ISO 10648:2)
GAMP5 software and FDA 21 CFR Part 11-compliant

Robotic arm with built-in gripper for both vials and syringes
Dispensing filter integrity test
Dispensing system for vials and syringes
Integrated dose meter
1 single-batch kit with a 0.22 µm filter
.webp?width=400&height=535&name=NEXT-automatic-dispensing-vials-syringe-main%20(1).webp)
Class A main chamber with laminar flow: vertical, across the entire surface of the chamber; horizontal, limited to the nozzle shielding area
Class B pre-chamber with turbulent flow
Integrated dose calibrators
2 shielded compartments for liquid and solid waste
1 video camera
Inflatable seals to ensure Class II airtightness (ISO 10648:2)
GAMP5 software and FDA 21 CFR Part 11-compliant
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Case Studies
From the Clinic to Production: Case Studies Demonstrating Integration, Compliance, and Continuity.
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