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VI

The visual inspection and labeling systems are automatic machines designed to inspect filled vials.
They are stand-alone units designed to be placed inside the working area of hot cells.

VI is available in various models, ranging from the inspection unit alone, to the version with an integrated labeling unit, up to the version with an additional printing and labeling system that can be integrated into a technical compartment of the hot cell.

Used in contexts of:
Radiopharma Production

Designed and Manufactured by Tema Sinergie

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VISUAL-INSPECTION-main (1)

GAMP5

FDA CFR21 part 11

details that matter

Designed for Your Process

CRP Compact is designed to streamline a critical phase: the dispensing and capping of vials under sterile conditions, reducing manual intervention and batch-to-batch variability. Its value lies not only in automation, but in its ability to adapt to real production needs: handling of open/closed vials, different capping strategies, and customizable workflows.

In regulated environments, this operational consistency results in a process that is more controllable and easier to transfer between shifts and production lines.


  • Customized workflows with dedicated kits
  • Vial format change even between consecutive batches
  • Crimp and push-fit management (depending on the version)

models

Three Configurations, One Flexible Platform

Choose the solution that best fits your workflow, ranging from standalone inspection to fully integrated inspection and labeling.

VI

Stand-alone unit for inspecting pre-labeled vials in a Class A environment— for all hot cells on the market.


VI consists of its own stand-alone unit, which is designed to be placed inside the hot cell in the main work area.

VI +

Stand-alone unit for inspecting and labeling vials in a Class A environment —for all hot cells on the market.


VI+ consists of its own stand-alone unit, complete with a labeling system, designed to be placed inside the hot cell in the main work area.

VI ++

Integrated unit for inspecting vials in a Class A environment, with an additional system for printing labels and applying them to vials. The printer and labeling unit are located in an unclassified technical area integrated into the hot cell.


Suitable only for Tema Sinergie hot cells; this must be discussed with the Tema Sinergie Technical Department during the quotation phase.

Settings and Customization

VI---2023-AT

LABELING UNIT

The labeling unit is completely removable to facilitate label tape replacement and maintenance.
The labels must be pre-printed and then placed on the labeling unit. This operation can be performed in a non-classified area before installing the labeling unit in the VI+ inside the Class A hot cell.
NOTE: Once the labeling unit is installed, the Class A area must be decontaminated before starting daily work, in accordance with the SOP.

VIDEO CAMERA AND EXTERNAL MONITOR

The Visual Inspection system is equipped with:
– an internal shielded camera to view the vial during the rotation and inspection process;
– an external monitor, to view and inspect the vial. This monitor can be mounted on the swinging arm of the hot cell, where it is fully accessible to the operator.

Key Features and Functions

Method

How We Approach Department Operations

A clinical-first approach: reduced surgical risk, consistent procedures, and support until stabilization.

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Step 01

Design Focused on Clinical Use

Solutions designed to accommodate shifts, schedules, and departmental constraints.

Step 02

Built-in security (not an add-on)

Radiation protection and procedures: an integral part of the project, not an afterthought.

Step 03

Start-up and training to stabilize the department

Quality becomes apparent after delivery: commissioning and training reduce variability.

Step 04

Solutions designed to accommodate shifts, schedules, and departmental constraints.

Reduce downtime and manage the department's evolution with clear support.

Settings and Customization

CRP Compact is highly customizable to meet specific production needs, vial types, and capping strategies.

CRP-Compact-Dispensers-Injectors-NM-11-PLUS-copy1

Precise

It can be used to process a very wide range of radiopharmaceuticals in vials, always in full compliance with the latest GMP specifications.

Multitracer

It can be used to process a very wide range of radiopharmaceuticals in vials, always in full compliance with the latest GMP specifications.

Automatic

It automates the entire radiopharmaceutical dispensing process, minimizing the need for manual intervention by the operator.

Compact

Thanks to its compact size, it can be installed in any type of shielded laminar-flow chamber equipped with a well for a calibrator and a remote gripper.

PRODUCT OPTIONS

Additional Features and Options

Push-Fit Capping Module

Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.

Push-Fit Capping Module

Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.

Push-Fit Capping Module

Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.

Key Features and Functions

Technical Specifications

Feature Value
Volumetric Accuracy (Weight) <1% (deviation)
Vial Compatibility Open / Closed (with piercing module)
Type of closure Crimp (stopper + ring), Push-fit
Dispensing speed Up to X ml/min (depending on the vial)
Volumetric Accuracy (Weight) <1% (deviation)

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Case Studies

Results in Real-World Settings

From the Clinic to Production: Case Studies Demonstrating Integration, Compliance, and Continuity.

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