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MODUS
Modular dispensing system for back-to-back production

Introducing MODUS, Comecer’s groundbreaking new modular radiopharmacy dispensing system.

Imagine a system that can prepare up to four different radiopharmaceuticals sequentially, without the need for time-consuming cleaning and decontamination between batches.

MODUS is that system.

MODUS - Comecer Modular Dispensing System

MODUS at a glance

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.

Base module

MODUS - Comecer Modular Dispensing System - Base Module

The base module is the basic element of the system and is responsible for the vial handling operations. The main components and key features are:

  • Vial transfer system gently manages the movement of vials through the module.
  • Automatic needle handling unit for accurate positioning of the needle over the dispensing position.
  • Gentle-grip stations for Stopper and Aluminum Cap.
  • Crimping head with integrated closure check system.
  • Precision scale with reduced profile in relation to laminar airflow.

Dispensing module

Integrated into the base module, it is possible to add up to four dispensing 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.

Production Optimization and Savings
ONLY ONE SYSTEM UP TO FOUR PRODUCTIONSCost reductions through increased production volume.Continuous production without decontamination cycles lowers operational expenses.Higher production volumes efficiently.
Space Efficiency
Multiple independent productions, optimizing space utilization.Improved usability without compromising space.
Scalability and Continuity
Consecutive production cycles in short intervals, referred to as “back-to-back” production.Immediate preparation of the next radiopharmaceutical after one has been dispensed.Facilities can start with a single Modus module and expand the system as needed.

4 configurations

Dispensing Hot Cell

The MODUS DISPENSING HOT CELL is a shielded Class A isolators equipped with laminar flow on the entire main chamber.

The MODUS DISPENSING HOT CELL is specifically designed to house the MODUS dispensing module, in sterile conditions and in compliance to cGMP standards.

The machine has unique features such as such as pass throught calibrator , integrated vial printer and integrated solid and liquid waste.

Key features and benefits

  • Dispensing chamber air quality Class A with laminar flow
  • Gloves pre-chamber air quality Class A with laminar flow
  • Ideal for medium and large productions
  • Spacious work chamber for optimized ergonomics
  • Dose calibrator for bulk
  • Product extraction system equipped with “Pass-through dose calibrator” and integrated vial printer
  • Product extraction system in transport shielded container
  • Touch-screen operator panel
  • Solid waste compartment air quality Class C
  • Integrated liquid waste connections
  • Sanitation system with VPHP (vapor phase hydrogen peroxide)

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 designed with a strong focus on ensuring the safety of the radiopharmaceutical dispensing process. It offers an optimised and protected work environment, essential for radiopharmaceutical operations. After all, this is evolution too. Modus is a step forward, guaranteeing safety and efficiency in the radiopharmaceutical industry.

 

Frequently Asked Modus Questions and their Answers

As we travel to industry events worldwide and present our Modus product, there are a few questions from booth visitors that generally come up. Here are the most common ones, with their answers.

How many vials can be dispensed per batch?
A maximum of 30 vials (including QC vials), with a maximum total of 120 vials for the entire production session.

Is sequential multi-batch only possible for the same radiopharmaceutical or can they be different?
Sequential multi-batch dispensing of radiopharmaceuticals of the same type and/or different types and/or based on different radioisotopes is possible.

Is it possible to use other vials besides the standard “Comecer” format?
Yes, it is possible to dispense vials in the range D: 22-36mm, h: 45-65mm with format change. The set of formats to be used at the same time is however to be checked in the offer phase.

Can the dispenser be installed stand-alone?
The Modus requires installation in the dedicated cell to allow working in Back to Back configuration.

MODUS - Comecer Modular Dispensing System + illuminate

Release the full potential of MODUS with Illuminate™ Manufacturing Intelligence

Use real-time machine performance data to pinpoint where to focus efforts to reduce downtime, maximize line throughput, improve product quality, and make sustainable production improvements. Learn more »

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