I-Pak Pharmaceutical Inspection System

Delivering high performance inspection and traceability

intervisionglobal.com +44 (0) 1926 611740

Requirement

Manufacturer of a Pharmaceutical product that has a printed label applied to it. The label contains a number which is unique to the batch. The manufacturer required Machine Vision system be deployed that can verify the printed number is correctly marked on each product.

As the production process must be validated it is essential that the system enables manufacturers to comply with FDAOs current Good Manufacturing Practices and meets the requirements of 21 CFR Part 11 through user access control features and audit trail capabilities. The label is manufactured of transparent material. The product beneath it is reflective but is curved not flat. Three different colours of product must be processed; blue, white and yellow. Therefore, a lighting technique that ensures a repeatable image with good contrast between foreground (human readable characters) and background (the label) must be selected. The system must integrate with the existing control system (i.e. utilise the existing hardware trigger and interface with the existing PLC to facilitate product reject). As the human readable string is unique to a batch the system must allow for rapid and simple updating of the string between batches.

Solution

To meet the requirement InterVision Global Ltd specified and deployed a Visionscape I-PAK inspection system.

Hardware

The system consists of a PC based machine vision system with VGA double speed camera. The PC is a high specification rack mounted IPC from Siemens. Enabling compliance with FDA requirements

The software incorporates several key features that enables compliance with FDA requirements;

  • Scalable Access Protection
  • Audit Trail Function
  • Automatic Logging of Program Changes
  • Reconcile Function
  • Comparison of Two I-PAK Applications and Identification of Modifications
  • Archive/Restore functions
  • Data Security on Power Failure

The Smart UPS that is deployed interfaces via USB with the I-PAK software; if mains power supply is lost then the smart UPS causes I-PAK to shut down in a controlled manor ensuring that no data is lost, no product is lost and inspection can resume from the point at which it was interrupted when production resumes. 

InterVision Global also supplied a floor standing stainless steel cabinet which houses the PC and an uninterruptible power supply unit and other control gear. The camera is supplied with lockable lens and aperture rings to ensure that no mechanical or optical alterations are made once the system is validated. The lighting unit is an NER SCDi illuminator.

Simple user interaction
Visionscape I-PAK was the right choice for this application because the windows based software platform for building and testing the inspection job utilises drag/drop and copy/paste functionality with which computer users are familiar. This enables the engineers to learn quickly how to troubleshoot, offline, tune and support this production critical equipment. The user interface allows an operator to use a standard keyboard to key in the new string upon batch change over. Specifying the correct illumination Before specifying the hardware the customer provided InterVision Global with samples of the product that was to be inspected. In their vision evaluation facility InterVision Global identified the correct illumination technique to be square continuous diffuse illumination. This technique provides extraordinary diffuse illumination performance and is designed for critical applications involving highly specular surfaces where any reflections will cause a vision system to see defects where none exist.

Straight forward Integration
The I-PAK system is supplied with 16 programmable digital I/O lines as well as strobe and trigger lines for each connected camera thus making integration with the existing line control simple.

Ensuring trouble free commissioning and integration
The key to supplying a system that is valued by its users often lies in ensuring its smooth introduction. InterVision Global have an extensive and successful experience of supplying and deploying OCR/OCV and AutoID systems to the pharmaceutical industry. InterVision Global were able to utilise this expertise to ensure that the system was installed and commissioned in a timely and professional manor. The customers engineers were then able to validate the system and put it on line on schedule and without further intervention.

Vision Expertise
Successfully deploying a machine vision system requires proven expertise and experience. It is essential that lighting, optics and algorithms are selected and applied to take account of product manufacturing variations, line speed, throughput and performance requirements.

InterVision Global have many years’ experience and great expertise in specifying and deploying I-PAK systems to the pharmaceutical industry.

Services Offered

  • Application Evaluation
  • Line Trials
  • Documentation
  • Hardware Specification
  • Commissioning
  • Training
  • Support
  • Validated systems

The Visionscape I-PAK inspection system is the proven solution chosen by major pharmaceutical manufacturers worldwide. Based on a selection of powerful machine vision tools and a simple user interface, I-PAK meets demanding pharmaceutical industry requirements for reliable, accurate and validated inspection of labels and products. Typical applications include date/lot code verification, component ID verification, and a variety of other package, label or product inspections.

Powerful Software
Based on the powerful Visionscape software, I-PAK offers a comprehensive selection of proven vision processing tools. The I-PAK user interface makes setup and deployment of applications fast and easy, and allows 100% verification of every product on the line.

Fail-Safe Identification
I-PAK provides fail-safe identification of incorrect or illegible characters while tolerating normal print variation. Proven robust OCV algorithms adapt to acceptable changes in preprinted or overprinted codes to reduce false rejects.

FDA Compliance
I-PAK enables manufacturers to comply with FDAOs current Good Manufacturing Practices and meets the requirements of 21 CFR Part 11 through user access control features and audit trail capabilities.