Regulations don't wait
EU FMD requires a unique, verifiable identifier on every pack. Without it, product cannot ship to regulated markets.
In production at
Built on industrial components you already trust
- Cognex vision
- Siemens PLC
- TraceLink
- GS1 DataMatrix
Batch report
Every batch closes with a complete report.
Each code issued for the batch is listed with its result, next to the totals for passed and rejected cartons.
- Serial, lot, expiry and result for every carton.
- Totals and pass rate calculated automatically.
- Saved as a PDF on your own hardware.
Production reportExample batch · daily run
Batch complete- Codes issued
- 21,000
- Passed
- 20,000
- Rejected
- 198
- Pass rate
- 99.02%
| (21) Serial | Result |
|---|---|
| 7Q4M2K9X1B | PASSED |
| K82TZ5W0NP | PASSED |
| 3HV9RJ6C4D | REJECTED |
| W1N7PA2E8S | PASSED |
The serialization gap
Compliance is mandatory. Enterprise platforms weren't built for you.
Enterprise systems are oversized
Multi-tier software, dedicated servers and validation teams are sized for hundreds of lines, not the one or two you run.
A failed code is a failed shipment
Unreadable or unverified codes lead to rejected shipments and recalls. Every carton has to be checked, not sampled.
How it works
One compact line: feed, print, verify, reject.
iX-Nilatis automates the whole serialization step on a single conveyor, and keeps the evidence for every carton.
- 01
Feed
Cartons enter the conveyor. A product sensor and synchronized speed measurement track each one.
Siemens PLC · product sensor - 02
Print
A unique GS1 DataMatrix with GTIN, serial, lot and expiry is printed on every carton.
Industrial TD pro printer - 03
Verify
A Cognex camera reads every code and checks its print quality before the carton moves on.
Cognex vision - 04
Reject & report
Failed cartons are blown off the line automatically. The batch report exports for TraceLink.
Pressure-valve blower · TraceLink export
Hardware
Standard industrial components in every station.
From the PLC to the reject valve, each part comes from an established manufacturer.
01Cognex camera
Reads every code and grades its print quality.
02Industrial printer
Prints the GTIN, serial number, lot and expiry on each carton.
03Reject valve
Blows failed cartons off the line with a pressure valve.
04Siemens PLC
Runs the conveyor and keeps printer, camera and reject in sync.
05Conveyor
A product sensor and speed measurement keep every carton tracked.
180/mincartons, validated with manual feeding
50,000+cartons processed in one production batch
100%of cartons checked by the camera, none sampled
On-sitebatch records stay on your own hardware
On every carton
Every carton carries a code you can prove.
An example GS1 DataMatrix, printed with its human-readable lines. It holds the first serial of the batch report above: scan it with any GS1 barcode app.
- (01) GTIN
- Global Trade Item Number identifying the product.
- (21) Serial number
- Unique for every single pack.
- (10) Lot
- Batch the pack was produced in.
- (17) Expiry
- Expiration date, encoded YYMMDD.
Sized for one line
The essentials of serialization, without an enterprise rollout.
Most track-and-trace platforms are designed for multinational manufacturers with hundreds of lines across many sites: multi-tier software, dedicated validation teams and enterprise licensing. Nilatis builds for the factory with one line that has to be serialized now.
Typical enterprise platformNilatis
Built forMultinational manufacturers running hundreds of linesA single line in a small or medium factory
HardwareDedicated enterprise server infrastructureA mini PC or industrial PC at the line
Software stackSeparate layers for line, site and cloudOne integrated system on the line
PricingEnterprise licensing agreementsPriced for the scope of one line
Compliance coverage
Designed around the standards you have to meet.
iX-Nilatis does the carton-level work each framework depends on: coding, verification and the batch record. Your uploads and reporting stay in the process you already follow.
EU FMD / EMVO
A unique identifier in a 2D DataMatrix on every prescription pack.
Prints and verifies product code, serial number, batch and expiry on each carton, with reports ready for your EMVS upload workflow.
GS1 DataMatrix
GS1 application identifiers encoded in a readable, gradeable 2D symbol.
Encodes (01) GTIN, (21) serial, (10) lot and (17) expiry, and checks print quality with a Cognex camera.
TraceLink
Serial numbers provisioned and reported through your TraceLink account.
Imports provisioned codes or generates them on demand, then exports production reports for upload.
Data & security
Your production data stays on your line.
iX-Nilatis runs on a mini PC or industrial PC that you control, not on a cloud subscription. Batch records and code history are created and stored on your hardware, and leave your site only when you export them.
On-premise by default
The platform runs entirely on hardware installed at your factory. No production data is routed through our servers to operate.
You control every export
Batch reports and TraceLink exports happen on your schedule, from your line, not automatically to a third party.
No production data resale
We don't sell, rent, or share your production or batch data with anyone, consistent with our privacy policy.
In production
Running daily at Remedina.
Remedina S.A. runs iX-Nilatis on its packaging floor, with the same printing, verification and rejection workflow described on this page.
The line prints and verifies the GS1 DataMatrix on Remedina's cartons as part of the daily packaging run.
Visit remedina.grWhy Nilatis
A focused team that builds, installs and supports your line.
We have one job: making serialization practical for manufacturers that enterprise vendors overlook. We design, build, install and support every line ourselves.
Talk to the engineers
The people who built iX-Nilatis are the people who answer your call.
Installed by the people who built it
The team that designed your line installs it on your packaging floor.
Shaped by real packaging floors
New features come from customer lines, including custom inspection and traceability projects.
FAQ
Frequently asked questions
What is iX-Nilatis?
A serialization line for pharmaceutical cartons. It prints a GS1 DataMatrix on every carton, checks each code with a camera, rejects failed cartons automatically and keeps the complete batch record.
Does iX-Nilatis work with TraceLink?
Yes. You can generate codes per batch or import codes already provisioned in TraceLink, then export the production report for upload.
What's the difference between iX-Nilatis and a custom system?
iX-Nilatis is a standard serialization line for small and medium pharmaceutical factories. Custom systems are designed for manufacturers that need special inspection logic, line-side scanning or traceability across production, storage and shipping.
What hardware is included in an iX-Nilatis line?
An electrical control system with a Siemens PLC, a conveyor with a product sensor and synchronized speed measurement, a Cognex camera for verification and print-quality inspection, an industrial TD pro printer, and a pressure-valve blower for automatic rejection.
How fast is the iX-Nilatis line?
It has been validated at 180 cartons per minute with manual feeding, and has processed more than 50,000 cartons in a single batch. There is no fixed limit on lot size; it depends on your packaging and feeding capacity.
What operating modes does the software support?
Manager view for creating or importing codes, configuring the line and managing backups; Operator mode for guided daily production; and Monitoring mode for a live view of validated and rejected cartons.
Where is production data stored?
On the mini PC or industrial PC at your line. The system does not need our servers to run, and batch data leaves your site only when you export it.
Who installs and supports the line?
The same team that designs and builds it. The engineers who built iX-Nilatis install it on your floor and answer your support questions.
Technical demo
See iX-Nilatis on your packaging format.
A working session with the engineers who build the line. We go through printing, verification, rejection and TraceLink reporting for your cartons and your line speed.