PRODUCT CATALOG2018

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To help ensure that CMOs and pharmaceutical companies are able to comply with regulations in time, OPTEL GROUP has developed ready-to-use, preconfigured serialization modules. These fast track to serialization products are preconfigured to enable existing pharmaceutical packaging lines to meet compliance fast. Delivered quickly, they are the perfect solution to tight regulation deadlines — plus, they are easy to operate and require only minimal training.

As a competitive CMO or pharmaceutical company, you need to accommodate a multitude of packaging types, sizes and configurations. Our units were specifically created with that in mind and allow for various product sizes, speeds and print locations — with minimal downtime for optimal productivity and performance.

OPTEL’s preconfigured solutions are also designed to be scalable, which will allow you to build on these units in the future, as your serialization operations expand. We understand that modifying your processes can be challenging and, to overcome this challenge, we have leveraged all the experience we’ve gained through the integration of thousands of serialization projects around the world. Our preconfigured solutions incorporate all

ABOUT OPTEL

29 years’ experience in traceability solutions

3,500+ solutions deployed

850+ employees

5 locations: Canada, USA, Ireland, India, Brazil

24/7 global technical support

this know-how to provide all the necessary features to scale up your serialized production and therefore maintain and generate additional revenues when you’re ready.

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CARTONTRACKERTM

pharma medical devices other

The CartonTrackerTM performs printing and inspection of up to 400 cartons per minute. This automated system provides great stability for printing and inspection, and includes an integrated ejection compartment for rejected cartons. The software can also generate reports for production monitoring and auditing. The CartonTracker is an ideal solution for areas where it is not possible to position cameras or printers.

This unit can be customized or preconfigured.

▶ Inspections and printing on up to three sides of the carton

▶ Compact unit (width: 60 cm to 150 cm)

▶ Simplified integration into the production line through conveyor belts

▶ Both inkjet and laser printers can be used

▶ Setup enabled by handles with position indicators

▶ Ejection control for rejected products

▶ Up to 400 cartons per minute

▶ NR 12, 21 CFR Part 11 and European Annex 11 compliance

GENERAL CHARACTERISTICS: MAIN BENEFITS:

THE CARTONTRACKER™ OFFERS A SCALABLE CONFIGURATION,

ENABLING ITEM-LEVEL SERIALIZATION AT FIRST

AND EASILY CONVERTING TO SERIALIZATION AND AGGREGATION

WHEN NEEDED.

FAST AND ACCURATE CARTON SERIALIZATION

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HOW IT WORKS:

After printing, the camera inspects the quality and the details printed on the carton. The details are verified against the batch recipe and once they are approved, the unique identification number is changed to “commissioned” or “active”.

The OPTEL software validates all the printed details and generates a report of all the activities (encoding, commissioning, destruction, sample, etc.) for production monitoring and auditing.

Cartons that fail the inspection are removed from the line through an integrated ejection system.

The cartons arrive at the level of the CartonTracker on a conveyor belt and, at this point, a unique identifying number and other batch details (expiry date, batch number, etc.) are printed. At this stage, the identification number is classified as “encoded”.

FOR MORE INFORMATION, VISIT: optelpharma.com/solutions/carton-tracker/

pharma medical devices other

The PackStation SAPTM is designed to read the serial number of each product in the case, without compromising the line’s packaging speed. The station makes it possible to read multiple layers of cartons in a single case. It is compatible with GS1 serial number formats, and this solution includes an adjustable railing to support multiple sizes of products.

In order to maximize packing efficiency, a printer automatically applies a label onto the case. After reading, the machine also carries out inspection of the labels for their activation. The PackStation SAP increases your manual packing speed and connects to the line management software (LineMasterTM) in real time in order to verify and report the serial numbers.

▶ Portable unit

▶ Automatic aggregation

▶ Automatic set-up adjustments

▶ Motorized arm for automatically adjusting the focus of the cameras

▶ Aggregation of several layers of cartons

▶ NR 12, 21 CFR Part 11 and European Annex 11 compliance

▶ Serialized and non-serialized capability

▶ Wide variety of box sizes

GENERAL CHARACTERISTICS: MAIN BENEFITS:

The OPTEL unique barcode-reading technology gives you the most efficient reading, ensuring maximum performance of the packing operation.

The unit can be customized or preconfigured.

THE PACKSTATION™ SAP IS A SEMI-AUTOMATED PACKING STATION THAT ENSURES THE IDENTIFICATION

AND VERIFICATION OF MANUALLY PACKED PRODUCTS WITH CAMERAS.

A SEMI-AUTOMATED PACKING STATION

PACKSTATION SAPTM

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HOW IT WORKS:

The cameras inspect the Data Matrix 2D barcodes of all the cartons, aggregating them into the case.

Once the case is full and the cartons have been read, the printer automatically prints the label and applies it to the case.

The operator presents the case so that the camera can inspect its label, confirming the aggregation of the cartons in the case.

The OPTEL software validates all the printed details and generates a report of all the activities (encoding, commissioning, destruction, sample, etc.) for production monitoring and auditing.

The cartons are manually placed inside the case, with the 2D barcodes positioned so that the cameras can read them.

FOR MORE INFORMATION, VISIT: optelpharma.com/solutions/packstation-sap/

pharma medical devices other

The PackStation FMPTM is a manual solution for the identification and verification of manually packed products with barcode scanners. This system allows operators to identify and verify labels at any packaging level, including bottles, cartons, bundles, shipping cases or pallets, to manually perform the reading of barcode data. Equipped with a dedicated HMI and with complete coder control, the PackStation FMP allows operators to manually request label printing of predetermined packaging levels for manual application, perform rework operations and view serialization data.

The unit can be customized or preconfigured.

▶ Portable unit

▶ Serialization and aggregation at any packaging level

▶ Rework station

▶ Compatible with multiple types of packaging

▶ Allows connectivity to multiple systems and/ or machines from other manufacturers

▶ NR 12, 21 CFR Part 11 and European Annex 11 compliance

GENERAL CHARACTERISTICS: MAIN BENEFITS:

THE PACKSTATION FMP IS A COMPLETE MANUAL PACKING

STATION THAT ENSURES THE IDENTIFICATION AND VERIFICATION OF MANUALLY PACKED PRODUCTS

WITH BARCODE SCANNERS.

FULLY MANUAL PACKING STATION

PACKSTATION FMPTM

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HOW IT WORKS:

Once the case is full and each unit has been read, the printer automatically prints the label and the operator applies it on the case.

The operator scans the case label to complete the aggregation, and places the case on a pallet.

Once the pallet is full, the pallet label is printed automatically. The operator applies it on the pallet and has to scan it to complete the pallet aggregation.

The OPTEL software generates a report of all the activities (encoding, commissioning, destruction, samples, etc.) for production monitoring and auditing.

The operator scans each carton or bottle and places them in a case.

FOR MORE INFORMATION, VISIT: optelpharma.com/solutions/packstation-fmp/

pharma medical devices other

The Manual Print StationTM (MPS) efficiently prints and verifies your cartons to ensure accurate serialization identification and allows you to perform manual labeling and aggregation on up to three subsequent packaging levels. This unit is manual, ultra-compact, and fully autonomous and can deal with a wide range of sizes of cartons and cases. It’s ideal for manual, low-speed lines.

This system enables you to choose between generating serial numbers automatically, getting them through integration with ERP software, or inserting them manually. The system also allows you to generate numerous reports: EPCIS, reconciliation, batch trail, audit trail, etc.

This unit can be customized or preconfigured.

▶ Fast and accurate handling of a range of carton sizes

▶ Compact, portable unit

▶ Simultaneous printing and inspection

▶ Complete reporting and reconciliation tool

▶ Setup enabled by handles with position indicators

▶ NR 12, 21 CFR Part 11 and European Annex 11 compliance

▶ Serialized and non-serialized

GENERAL CHARACTERISTICS: MAIN BENEFITS:

THE MANUAL PRINT STATION™ IS A COMPLETELY MANUAL STATION

FOR PRINTING AND VERIFICATION OF CARTONS, ENSURING ACCURATE

SERIALIZATION IDENTIFICATION.

EFFECTIVE ENTRY-LEVEL SOLUTION FOR FAST SERIALIZATION IMPLEMENTATION

MANUAL PRINT STATIONTM

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HOW IT WORKS:

The OPTEL software validates all the printed details and generates a report of all the activities for production monitoring and possible audits.

The serialized cartons are placed in the case, and the electronic product codes (EPCs) validation of the cartons is done with the manual reader for aggregation into the case.

The desktop printer automatically prints the case label after the operator has read the final carton. The label is then manually applied to the case.

The operator performs the same process of reading the serialized code of the case and confirms the aggregation for the other packaging levels, cases and pallets.

With just one movement, the operator prints the details with the thermal inkjet printer and inspects them thanks to the high-resolution camera positioned on the equipment.

FOR MORE INFORMATION, VISIT: optelpharma.com/solutions/manual-print-station/

pharma medical devices other

The CLTracker TETM was developed to be implemented into any tamper-evident carton labeling or sealing unit. The system performs printing and verification of the printed information on each carton, guaranteeing accurate serialization. In addition, the CLTracker TE automatically manages the status of serial numbers. If a carton is rejected because of a defect in the printed details or the seal, the CLTracker TE will automatically change the status of the serial number and record the changes in its database.

This unit can be customized or preconfigured.

▶ Serialized and non-serialized capability

▶ Automatic serial number status management

▶ Complete reporting tool for the software managing the line (LineMaster™)

▶ Up to 400 cartons per minute

▶ Allows connectivity to multiple systems and/or machines from other manufacturers

▶ NR 12, 21 CFR Part 11 and European Annex 11 compliance

GENERAL CHARACTERISTICS: MAIN BENEFITS:

THE CLTRACKER TE™ HANDLES THE PRINTING AND VERIFICATION OF EACH CARTON AND ENSURES

ACCURATE SERIALIZATION IDENTIFICATION.

TRACK & TRACE SOLUTION FOR CARTON LABELING MACHINE

CL TRACKER TETM

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HOW IT WORKS:

After printing, the camera inspects the quality of the details printed on the carton and whether the seal was correctly applied. The details are verified against the batch recipe and the unique identification number is changed to “commissioned”.

The OPTEL software validates all the printed details and generates a report of all the activities (encoding, commissioning, destruction, sample, etc.) for production monitoring and auditing.

Cartons that fail the inspection are removed from the line through the integrated ejection system of the CLTracker TE and the status of the serial number is changed to “de-activated” or “destroyed”.

Cartons arrive at the level of the sealing machine on a conveyor belt and a unique identifying number and other batch details (expiry date, batch number, etc.) are printed. At this stage, the identification number is classified as “encoded”.

FOR MORE INFORMATION, VISIT: optelpharma.com/solutions/cltracker-te/

pharma medical devices other

OFFLINELABEL TRACKERTM

The Offline LabelTrackerTM allows you to meet serialization and aggregation regulations by printing and inspecting labels offline, for bottles, cartons, cases or pallets. This portable, compact unit can be installed in label rooms or next to the production line. When the label is printed, the traceability system verifies its compliance. After a roll is printed and inspected, it can be installed on the production line labeler, which means there is no need to modify the line labeler. The same process can be applied to cartons, cases and pallet labels. In addition, it is possible to choose between generating serial numbers automatically or uploading them manually. The system also allows you to generate numerous reports, such as EPCIS, reconciliation, batch trail, and audit trail.

The unit can be customized or preconfigured.

▶ Autonomous, portable unit

▶ Prints and inspects serialized labels offline

▶ Compatible with different label formats

▶ Serialized and non-serialized

▶ 130 labels per minute

▶ Allows connectivity to multiple systems and/or machines from other manufacturers

▶ Fast delivery

▶ NR 12, 21 CFR Part 11 and European Annex 11 compliance

GENERAL CHARACTERISTICS: MAIN BENEFITS:

THE OFFLINE LABELTRACKER™ ALLOWS YOU TO EASILY MEET

SERIALIZATION AND AGGREGATION REGULATIONS BY ALLOWING

YOU TO PRINT LABELS OFFLINE, FOR BOTTLES, CARTONS,

CASES OR PALLETS.

SERIALIZATION AND INSPECTION OF LABELS OFFLINE

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HOW IT WORKS:

A unique identification number and/or batch details (expiry date, batch number, etc.) are printed on each label. At this stage, the identification number is classified as “encoded”.

After printing, the camera inspects the quality of the printout and the details printed on the label. The details are verified against the batch recipe and the unique identification number is changed to “commissioned”.

The OPTEL software validates all the printed details and generates a report of all the activities (encoding, commissioning, destruction, sample, etc.) for production monitoring and auditing.

Labels that fail the inspection process are manually removed by the operator.

The label roll is inserted into the Offline Label Tracker.

FOR MORE INFORMATION, VISIT: optelpharma.com/solutions/offline-labeltracker/

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