Key Features

Key Features

Single Source Global Solution

Crest Solutions ProTrack™ uniquely combines the key elements of traceability: product marking, identification, verification and real-time management information.  By implementing a single managed and proven solution from one supplier, you eliminate the cost and difficulties of integrating multiple smaller components.

Machinery, Peripherals & Software Integrated

All production environments require the addition of specific machinery, peripherals or software elements to create a full track and trace environment.  Crest Solutions have validated and proven installations that show our ability to implement all of these elements as your core partner in traceability.

Future-proofed Solution

The tipping point has been reached where regulatory requirements for full product lifecycle traceability will in future become the norm.  Forward-planning manufacturers are turning to Crest Solutions ProTrack™ to help them meet not just the regulations of this year or the next, but to future-proof their investment by meeting standards that regulators have already announced will be insisted upon many years from now.

Product Overview

Product Overview: Many Elements, One Global Solution

Traceability Environment

ProTrack™ manages the data required to meet current and future track & trace regulations.  It tracks a product from a single unit (carton) as it moves through intermediate batch stages (case) up to final storage/ despatch level (pallet).  It is a GS1 compliant solution, meaning that it meets the criteria set down by the world steering body for product traceability.

Code Marking & Management

This required data can be tracked using multiple methods of data-carrier on the packaging, e.g. 1D barcodes, 2D datamatrix, RFID and human-readable markings.  Crest Solutions ProTrack™ will generate the code, allocate it to the product and batch or can use imported pre-generated codes where required, whether these be serialised random or sequential codes.

Code Reading & Verification

The verification stage begins once the codes are allocated and applied either onto the product label or direct part marked onto the product.  The product is tracked through production using vision inspection cameras. These are used to verify that the product arriving down the line is the expected, intact and compliant product or it is rejected from the line.

Reject Handling/ Rework/ Scrap

Some products that are rejected are easily reworked and re-admitted to the process and ProTrack™ logs and permits this at rework stations.  Others are permanently rejected and are deducted from the batch or run.  The necessary stock updates to re-make the batch are managed and flagged up the line and recorded in the system for full reject tracking and scrap reconciliation.

Case Study

Case Study: Medical Devices

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.