LYO-CHECK
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    LYO-CHECK

    disruptive innovation in the visual inspection of lyophilized pharmaceutical products
    The Project
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    LYO-CHECK

    disruptive innovation in the visual inspection of lyophilized pharmaceutical products
    Product Technology

The Project

The aim of the LYO-CHECK project is to create two machines, one pilot machine and one fully automatic industrial machine, for the inspection of lyophilized pharmaceutical preparations intended for injection, based on the two elements of:

  1. an innovative vision architecture (dedicated software and optical layout);
  2. an ancillary technology (HSGA - head space gas analysis) for testing the sterility of the product via container integrity inspection.

 The two machines will be used for demonstration in operational environment with trials on potential customer’s products.

Scope

Pharmaceutical products intended for injection are becoming more and more commonly found in lyophilized form. 
This trend appears to grow steadily, especially for anti-infectives, biotechnology derived products, and in-vitro diagnostics.

In fact, lyophilized product shows the following characteristics:

  • Long term storage (more than two years), even at room temperature if stored properly;
  • Protection from pollution due to microorganisms activity;
  • Ease of transport and storage;
  • Rapid reconstitution of the product in contact with the appropriate solvent;
  • preservation of the original product features.

Nevertheless, the quality-control inspection of products in lyophilized form poses peculiar challenges, needing a dedicated system which is totally different from the one so far applied to inspect parenteral products in liquid form.

During the LYO-CHECK project, the new pilot and industrial machines will be used for demonstration in operational environment with trials on potential customer’s products. 

Impacts

The worldwide pharmaceutical market is driven by two main necessities:

  • a constant increase in product quality (in order to ensure patient safety and product compliance);
  • a constant increase in production output (in order to decrease the overall costs of the pharmaceutical product thus making it available to a wider spectrum of users).

Given that the lyophilized form is set to become the most widely used in the production of high added-value preparations for injection, the increase in product quality and production output can be achieved only by the combination of different factors and improvement strategies, which are being taken into account in the development of the LYO-CHECK machine.

The new automatic inspection process performed with the LYO-CHECK machine will impact the lyophilized products sector in terms of:

  • extended shelf-life for prolonged storage;
  • higher quality of product due to lower inspection errors;
  • lower overall process cost compared to manual inspection.

Organization

Antares Vision’s project for a disruptive innovation in the inspection technology for lyophilized products has been selected for funding within the European Union’s Horizon 2020 research and innovation programme thanks to: 

  • A winning idea for a substantial improvement compared to the current technologies;
  • The company’s well-proven competence in visual inspection, and specifically in the advanced analysis on liquid products;
  • A structured and dedicated engineering team;
  • A solid business plan and project timing, in view of the medium and long term exploitation of the innovation.

Contact

General info:

lyocheck@antaresvision.com

 

Project Coordination:

Davide Sacchetti / Antares Vision

davide.sacchetti@antaresvision.com