What is Pack Confirmation?

When packaging medical devices, each package shipped contains multiple elements in a kit, and the potential for absence or incorrect combination of these elements must be eliminated.  The consequences of failing to do this are immense, as many of the devices will be inserted into the human body during surgery.  It is critical therefore that every possible precaution is taken during the packaging phase to ensure that the correct pack has been formed.

Likewise in pharmaceutical packaging, it is critical that the IFU patient or doctor information leaflet must be shipped with the product and systems for verifying this have also been developed.

Image showing how appropriate lighting can assist in a complex task. Here the increase in contrast created by the UV lighting highlights the object of interest.  The vision camera captures this image and the software routines identify and verify it as per the expected result in the Pack Confirmation algorithm.  These are actual product images from a system used by a medical imaging liquids manufacturer in their proprietary Crest Solutions Pack Confirmation solution.

Why Crest Solutions?

Crest Solutions have implemented mission-critical solutions in the field of Pack Confirmation for pharmaceutical and medical devices manufacturers' packaging operations.  The unique combination of vision-based verification systems and database-driven software applications to manage this data that is required for an end-to-end Pack Confirmation system is rarely available in a single company.  By possessing this knowledge in-house, Crest can eliminate the need to have multiple vendors feeding into a single Pack Confirmation system, and have developed the ProTrack product to centralise the lifecycle management of the product during production and packaging phases.

Case Study: Medical Devices

Crest Solutions ProTrack™ is a product lifecycle management software system that accounts for every step a product takes along the supply chain in a single production location or as part of a global manufacturing operation. 

Crest Solutions have optimised ProTrack™ as a full product lifecycle traceability solution for a world leading manufacturer of prosthetic implants.  Each package shipped contains multiple elements in a kit, and the absence or incorrect combination of these elements must be avoided.

The key components of the system are:

Product Verification & Marking

In order to identify the prosthetic implants as they progress through the packaging operation, the initial stage is to mark directly onto the products’ surface using 2D datamatrix.  To ensure the correct product is the one being marked, the system uses vision technology to measure and gauge the part and pattern matches it to the expected product. 

Product Mix Avoidance

The next item in the kit is a blister pack.  Here the vision technology checks that the label on the blister matches the product inside.  Additional packed items in the blister must match the product.  The integrity of the seal on the blister must be perfect by checking the sterility dot colour and the print on the label must be correct and legible.  Errors in any of these factors are notified to the operator, logged in the system and appropriate actions taken.

Pack Confirmation

Crest Solutions ProTrackTM confirms that the box is correct and that the correct number has gone into a multipack.  The IFU patient/ doctor information leaflet must match the product.  ProTrack™ checks that the batch number is the expected one and writes the batch result to the tracking database.  This process continues as the batch is aggregated upwards into an overall pallet for shipping.

Conditional Printing

On-demand printing then occurs, managed by ProTrack™, whereby only when a batch is successfully verified is a confirmation label printed.  This label is also inspected, as it is generated, by the Crest Solutions PrintInspector™ product.  This is an in-line high accuracy print verification system for the type of large format labels commonly used by medical device manufacturers.

Summary

Full lifecycle traceability and product mix avoidance are key concerns for medical device manufacturers.  Crest Solutions ProTrack™ is the chosen solution in product mix avoidance, ensuring the correct combination of product, packaging, labelling and patient/ doctor information is shipped with every batch and that a full track & trace data record is created.

Crest Solutions ProTrack™ is a product lifecycle management software system that accounts for every step a product takes along the supply chain in a single production location or as part of a global manufacturing operation.