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NEXT

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.

 

 

Used in contexts of:

Designed and Manufactured by Tema Sinergie

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Class A

gmp

ISO 14644

Class II

ISO 10648:2

GAMP5

Overview

Automatic Dispenser for Vials and Syringes

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.

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FLEXIBLE

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.

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ASEPSIS

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.

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LIGHTWEIGHT

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.

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DATA MANAGEMENT

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.

Features

Next consists of:

Integrated, self-shielded dispenser

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  • 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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