Harletray. Pharmaceutical quality control system of products in tray

VISION SYSTEMS

Harletray is the colour vision inspection system for thermoforming and forming machines, made to inspect pharmaceutical products such as syringes, ampoules, or vials inside trays.

The quality control system always grants the highest performance and visual inspection results, regardless of the inspection complexity, allowing different checks from tray completeness or correct forming – up to products presence, colour, assembly, components presence, and other additional controls.

Quality inspection of products in trays

Components presence and correct assembly

Real-time operations visible on HMI

Reliable, accurate and fast

Optimized machine integration and rejection management

HARLETRAY

Cosmetic and presence inspection of pharmaceutical products in trays

Harletray is the colour vision inspection system designed to check products in trays during the packaging process on thermoformers and formers.

A set of algorithms developed to support any controls on any products and any material are the basis of Harletray – a powerful vision system made to avoid that a defective product contained in the tray can wreak the efficiency and the quality of the whole production.

Able to control 100% of the product during the packaging process, it guarantees the highest production quality, eliminating all mix-up to preserve the end user’s safety.

The quality control system can perform several checks, from the presence and completeness of products (syringes, vials, ampoules, cartridges, medical devices, squeezable tubes) in paperboard or plastic trays, to correct assembly and correct components presence. To ensure perfect control for each specific application, material, or machine configuration, Harletray is provided with an optimal combination of optics and LED light units according to the product to process.

The HMI display shows in real-time the results of every product checked and, while 100% of products units are inspected, the vision system manages the rejection of each non-compliant item. Harletray can be installed on every type of forming and thermoforming machine currently present on the market, without impacting the production speed and integrating itself perfectly thanks to the automation logic.

HANDLED PRODUCTS

Injectable forms, medical devices and their packaging

harletray products logo
100% COMPLETE INSPECTION

Accurate tray control, down to the finest details

Harletray inspects 100% of the production and can detect all possible defects of the products packaged in the tray, thanks to the wide range of controls it offers. From the correctness and integrity of the single product to the packaging’s completeness and defectiveness, all checks are customizable and can be carried out individually or in simultaneous combinations.

The vision system can detect even minimal size, shape, and color differences. Thanks to multi-product management, it is possible to check different products within the same tray.

Quality control on the single product

  • Ampoules (colour and number of colored rings, integrity, label presence and position).
  • Syringes (correct assembly, presence and correctness of the plunger rod, cap presence, needle cap presence and orientation, UV printed barcode control, stopper presence and position, safety device presence and activation, flange control, label presence and position, UV label presence, data matrix and variable data reading).

Tray controls

  • Presence and correctness of components inside the tray
  • Correct tray forming
  • Combined checks (Components presence and orientation, tray orientation)
  • OCV/OCR check of printed data on cover material
  • Code control (barcodes, 2D codes and alphanumeric codes) on the covering material
  • Print quality verification (PQV) on the covering material
  • Label presence (e.g. heat marker label)
  • Alucode (verification of tray covering material)

Customized controls

The vision system can perform a number of controls with customized parameters, by mean of the programmable measures function. It is a library of image processing applications that can be combined to create specific control with dedicated acceptance conditions as needed. An example? The control of several different syringes components in tray (plunger rod, plunger rubber stopper, safety device, backstop, barrel, needle shield and many others).

A FLEXIBLE SOLUTION

Inspected products and materials

Harletray can check the presence and integrity of any products in trays, for example:

  • Syringes
  • Cartridges
  • Vials
  • Ampoules
  • Medical devices
  • Squeezable tubes

Harletray performs inspections on different tray materials, for example:

  • Plastic
  • Paper
OPERATIVE PRINCIPLES

Designed to boost performances

Harletray makes use of cameras for the images acquisition and processing.

The values measured for each object are compared with reference models and, if one of them is outside the tolerance range, the system automatically send a signal to the machine, allowing the rejection.

An accurate inspection is granted, in just milliseconds. Such rapid elaboration times are possible thanks to Harletray system’s SIMD instructions developed in-house, and smart proprietary algorithms (designed upon the concepts of spatial and temporal parallelism) programmed to make the most of all the threads available in the latest generation CPUs.

Since threads divide the core of a CPU into many virtual multiple cores, the usage of all of them allow a computer processor to perform multiple tasks at the same time, and faster.

The result is that the algorithms of Harletray are able to improve theirself software computing power; reducing the images processing times, while performing more controls, and guaranteeing at the same time the best results in term of inspection accuracy and safety.

Hardware features

The importance of a good hardware

The system is provided with latest generation industrial computers including multicore technology and multithreaded processors, in order to take full advantage in terms of elaboration speed and accuracy.

Optics and light units components are specifically designed and assembled for an optimal inspection, and for perfect integration with the machines mechanical design. With optimized lighting management, the images acquisition speed is fast and accurate.

The touch-screen displays provided have an optimized graphic interface that increases usability and interaction.

Pharma specific solution

Security and compliance

The system is specifically designed for the pharmaceutical market, and it is compliant with the industry regulations, with user access regulated by FDA 21 CFR part 11 and annex 11.

All events are registered by the software in an audit trail file to keep track of all the security-relevant activities.

The continuous Software development follows Gamp 5, to always improve products quality and consistency.

Integration with machines

The result of a broad experience of vision systems integration

SEA Vision’s expertise in integration is built on decades of experience working alongside machine manufacturers to satisfy the needs of pharmaceutical customers worldwide

Such experience guarantees correct machine integration, accurate signal exchange management, and integrated automation and rejection logic.

Harletray can be integrated on machines with different automation levels, from entirely automated or semi-automated to modules with a low automation level.

The graphical oscilloscope allows the observation of signal patterns and keeps them under control, facilitating the diagnostical operation.
The entire process is handled efficiently, from the control execution to the rejection of defective products.

A reliable and future-proof solution

Native integration with yudoo

Harletray is natively integrated with Yudoo, the 4.0 pharmaceutical software suite for the full management of automation processes, digital quality, data analysis and for Track&Trace. A digital hub that is everywhere accessible through a secure-access web interface or dedicated devices.

A scalable and modular suite, including tools for automation (centralized management of production, workflows and timesheet), for the digital quality (creation of paperless systems, support systems for line clearance operations), for data analysis (analysis of production data, business intelligence dashboard, condition monitoring and predictive maintenance) and for Track and Trace (complete solutions for Level 3 and 4 of serialization, monitoring of serialization operations).

Yudoo offers multiple advantages such as the possibility to centralize production formats and data, avoiding duplicates and reducing work time. The suite can connect to existing company systems to retrieve updated data exactly from where they are.

A PORTFOLIO OF NATIVELY INTEGRATED SOLUTIONS

One player, one vendor, one solution provider

SEA Vision provides an extensive product portfolio of natively integrated solutions. Vision, traceability and data management solutions for pharmaceutical packaging lines are developed with a common approach to obtain a seamless ecosystem.

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