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Comecer's new radiopharmaceutical dispensing system that goes the distance

Written by Comecer | Jan 7, 2025 3:49:50 PM

Figuratively speaking, the term “evolution” indicates a gradual, continuous process of transformation through which a given reality evolves from one state to another through successive changes. This transition is generally conceived as an improvement or refinement from the initial state.

Modus, the dispensing system produced by Comecer, fully embodies this definition within the field of diagnostic radiopharmaceuticals, representing a clear example of technological and functional evolution. While its name derives from Latin for “way” or “method”, its innovative and structured approach reflects an essential concept in disciplines such as engineering, architecture and IT: that of modularity. In this context, the term “module” signifies a unit that can be easily replaced or exchanged with another similar component without needing to intervene on the rest of the system.

Modularity, an innovative concept

In the field of radiopharmaceutical dispensing, though, the concept of modularity has always struggled to establish itself. The equipment available on the market has so far only allowed for the production management of a single batch at a time; this approach makes it necessary to replace the disposable kit and start a complete cleaning and decontamination cycle in order to start a new batch and prevent cross-contamination. That was the reality up until the arrival of Modus, with which Comecer, starting from the very principle of modularity, devised a scalable dispensing system that is capable of processing up to four different radiopharmaceutical productions, even different ones, in a sequential manner.

For hospitals, private clinics, laboratories and other healthcare institutions that produce and use critical substances such as radiopharmaceuticals, the introduction of the Modus system represents a significant improvement. The flexibility, scalability and efficiency of this system provide a number of important benefits, including cost reduction, space optimisation and improved safety levels in the production process. How does Modus work?

The base and dispensing module: the modus structure

The Modus dispensing system consists of two main elements: the Dispenser and the Dispensing HC (Hot Cell). The technological heart of the system is the Dispenser, which in turn is subdivided into a base module and one or more dispensing modules.

Base module, the base module is the basic element of the system and is responsible for the initial pharmaceutical handling operations. This is where vial positioning and preparation takes place. Some of the key components of the base module include:

  • Automatic dispensing needle management device: This component ensures accurate and reliable dosing.
  • Cap and ring nut gripping systems (stopper gripper and overseal cap gripper): Allow safe handling of the vials.
  • Sealing system (crimping head): Ensures secure closure of vials after filling.
  • Vial transfer system: Automates the movement of containers through the module.

Dispensing module, integrated into the base module, the dispensing module offers the possibility of managing up to four modules. This flexibility allows the system's production capacity to be expanded. Each dispensing module is designed to operate independently, thus preventing cross-contamination between production batches and maintaining high quality and safety standards. A key element in preventing cross-contamination is the use of special disposable kits.

In short, the user-friendliness of Modus is one of the reasons why investing in a modular dispensing system is worthwhile.

Flexibility, affordability, space management: all the advantages of Modus

The Modus system offers numerous advantages that go beyond mere economics. Let’s have a look at them in detail:


Modus is therefore a complete solution that goes beyond economics, offering significant advantages in terms of productivity, scalability and space management.

 

Safety and Control with Modus: A Step Forward in the Radiopharmaceutical Industry

Process safety is a crucial aspect when it comes to radiopharmaceutical dispensing systems. Here is how our innovative system, Modus, addresses this issue:

  • International Standards and Best Practice: As with all Comecer products, Modus strictly complies with international safety regulations and best manufacturing practices. This guarantees that the system is reliable and aligned to the highest standards.
  • Advanced control: Using Modus means operating with a high degree of control compared to normal dispensing systems. How? Here are some key points:
    • Disposable kit: Modus uses a new, specially developed disposable kit to eliminate the risk of cross-contamination.
    • Phase automation: Automation of the dispensing process phases reduces the need for manual operations, minimising human error.
    • Intuitive user interface: Modus' intuitive user interface further helps prevent operating errors, facilitating correct use of the system.
  • Protected work environment: In conclusion, Modus is a solution that puts the safety of the radiopharmaceutical dispensing process at its centre. It offers an optimised and protected work environment, essential for radiopharmaceutical operations.

After all, this too is evolution. Modus is a step forward, guaranteeing safety and efficiency in the radiopharmaceutical industry.

Summary

Key features and benefits

  • Sequential processing of up to four batches: This system allows up to four batches to be processed consecutively without the need for cleaning or decontamination between batches.
  • Compliance with the latest EU cGMP Annex1: The system complies with the latest standards of Annex1 of the European Union Good Manufacturing Practice (cGMP).
  • A single solution for dispensing in open and closed vials: A complete dispensing solution which can be used for both open and closed vials.
  • Scalability: The minimum configuration handles a single kit but can be expanded up to four kits to meet production growth requirements.
  • A modular approach: In addition to expanding capacity, the system can be used as a backup solution.