From blister to pallet: matching the code to the job
Serialised 2D Data Matrix on every carton (FMD)
The Falsified Medicines Directive requires a unique serial number, product code, batch and expiry encoded in a Data Matrix on each saleable carton, printed cleanly enough to grade. Domino Gx-Series thermal inkjet coders print high-resolution, gradeable 2D Data Matrix codes and human-readable text onto folding cartons at line speed, with the print quality a serialisation grade demands. We tie the print into your serialisation system so each carton receives a unique, in-sequence code rather than a repeated one.
Code verification and ISO 15415 grading
A serialised code that does not grade is a code that gets rejected downstream, so every printed Data Matrix has to be read and graded in line, not sampled at the end. Zebra FS-Series fixed industrial scanners read and verify each code as it passes, checking it decodes and meets the grade before the carton is allowed through, so a misprint is caught at the printhead rather than at the customer. We set the reject logic so a failed code never makes it into a pack.
Domino Gx-Series TIJ & Dx-Series laser
Blister lidding foil is fast-moving, thin and unforgiving, and the batch and expiry have to print sharp without slowing the blister machine. Depending on the foil and the line, we fit either a Domino Gx-Series thermal inkjet for crisp variable text and codes, or a Domino Dx-Series CO2 laser where a permanent, solvent-free mark is preferred. Either way the code keeps registration through a full shift so the lidding never has to stop for the coder.
Coding vials, ampoules and bottles
Small cylindrical primary packs move quickly and present a curved, sometimes wet surface, which is exactly where a non-contact coder earns its place. Domino Ax-Series continuous inkjet coders jet batch, expiry and lot data onto vials, ampoules and bottles non-contact at high speed, and self-clean on shutdown so the first pack after a break codes as cleanly as the last one before it. For glass where a permanent etched mark is preferred, we specify a laser instead.
Permanent laser marking on cartons and devices
Where the mark has to be permanent, solvent-free and tamper-evident, ink is the wrong tool and a laser is the right one. The Domino Dx-Series CO2 laser etches batch, expiry and codes into cartons, labels and many device surfaces with no ink, no ribbon and nothing to wipe off, paired with a Domino fume extraction unit so the marking station stays clean and compliant. No consumable also means one fewer thing to reconcile in a GMP audit.
Tamper-evident closure labels
FMD requires a tamper-evident feature on the carton, and where that is delivered by a sealing label it has to be printed, applied and verified to a fixed standard. The Zebra ZT-Series industrial printer produces tamper-evident seal labels and security-feature labels at the durability and print quality a regulated pack needs. We set the templates up to your approved artwork so the right label, with the right variable data, prints every time.
GMP-compliant product and pack labels
Product, bottle and secondary-pack labels in a GMP setting have to be exactly right, legible and reproducible, because a wrong or faint label is a deviation, not just a presentation issue. The Zebra ZT-Series industrial printer produces high-resolution product and compliance labels from your validated templates and data, with the consistency a regulated line requires. We commission the templates against your real artwork and approval records so what prints matches what was approved.
Aggregation: case and pallet SSCC labelling
Serialisation only delivers full traceability when the carton codes are aggregated into the case, and the cases into the pallet, with an SSCC on each level. Zebra ZT-Series printers, configured for print-and-apply, produce and place the GS1-128 case and SSCC pallet labels that tie each shipper back to the cartons inside it, pulling the parent-child data from your serialisation system. The result is a hierarchy you can scan from pallet down to single pack.
Validation, IQ-OQ-PQ and audit-ready documentation
In a GMP environment a coder is not commissioned until it is qualified, and the qualification has to be documented to survive an inspection. Sirap supports installation, operational and performance qualification for the coding and labelling equipment we supply, with the protocols, test records and code-grade evidence an auditor expects. The point is that when an inspector asks how you know the code prints correctly, you have the paperwork, not just the machine.
Expiry and batch coding on secondary packs
Beyond the serialised Data Matrix, the carton still has to carry human-readable batch and expiry that a pharmacist and a patient can read, and it has to match the encoded data exactly. Domino Gx-Series thermal inkjet coders print clean, high-resolution batch, expiry and lot text alongside the code, driven from the same data source so the readable text and the machine-readable code never disagree. We integrate the print so both come from one record, removing the mismatch risk.
2D codes, GS1 Digital Link and Sunrise 2027 readiness
Pharma already lives in a 2D world through serialisation, and GS1's wider Sunrise 2027 move toward 2D codes at retail makes that head start an advantage. A coder specified for serialisation is already capable of the GS1 Digital Link and richer 2D codes that link a pack to batch, expiry and product information, which also makes onboarding with larger distributors and platforms simpler. We explain what is actually required, and what is not, in our guide to GS1 Sunrise 2027 for Maltese producers
Reading and capturing codes across the line
Printing and aggregating a serialised code is only half the job; you also need to read it reliably at every control point, from in-process checks to dispatch. Zebra DS3600 ultra-rugged scanners and Zebra TC5-Series mobile computers decode dense Data Matrix, GS1-128 and Digital Link codes reliably, so the same device handles primary, case and pallet reads. We tie the scanning points into your warehouse and dispatch workflow so each read lands in your system as evidence, not on a clipboard.
Genuine consumables and validated line uptime
In a validated environment the ink and the ribbon are part of the qualified process, so an off-brand substitute is not just a quality risk, it is a deviation. We hold genuine Domino inks and fluids and genuine Zebra labels and ribbons locally, matched to your equipment and the substrates you qualified, so a consumables run-out never becomes a line stoppage and code quality stays inside the limits you validated.
Coding and Labelling for Pharmaceutical Producers in Malta
Coding and labelling, specified and validated for your line, not picked off a shelf
A generic quote for “a date coder” is how a regulated line ends up with equipment that grades poorly, fails verification, or cannot be qualified cleanly. Pharmaceutical manufacturing is unforgiving that way: the same coder that is fine on a dry carton is the wrong tool on a curved vial, and a serialisation print that grades at the bench can drift out of grade at full speed if the station is wrong. Our approach starts with a survey of the actual line, the packs, the substrates, the throughput, the serialisation and verification requirements and the validation expectations, so the recommendation is built around how you really run and how you will need to prove it.
That local, hands-on service is the difference between buying a box and getting a qualified coding station. We commission codes to your real GS1, serialisation and date formats and verify they grade on your actual substrate, not just on paper. We support the IQ, OQ and PQ documentation your quality system needs. We provide operator training, including in Maltese, so the line team can clear a fault and keep running without waiting for a callout. And when something does need an engineer, the support comes from a team based here in Malta, not a queue overseas.
What Sirap covers on a pharmaceutical line
The hardware is the visible part; the service and documentation around it are what keep a regulated line releasing product. Across a typical pharmaceutical engagement we handle:
- Serialisation, batch and expiry coding across blisters, vials, cartons, cases and pallets
- In-line code verification and ISO 15415 / Data Matrix grading with reject control
- Case and pallet aggregation with GS1-128 and SSCC labelling
- Permanent laser marking for cartons, devices and tamper-evident codes
- GMP product, tamper-evident and compliance labelling from validated templates
- 2D barcode and GS1 Digital Link specification for Sunrise 2027 readiness
- On-site line survey, specification and commissioning
- IQ, OQ and PQ support and code-grade evidence for qualification
- Operator training, including in Maltese
- Genuine Domino and Zebra consumables held locally, matched to your validated process
- Malta-based engineer support and service cover
When a label, or a different tool, is the right call
Direct coding is not the universal answer, and on a regulated line pretending otherwise would cost you more than trust. A printed label is the right choice when the surface is too small, curved or reflective to grade a direct code reliably, or when a tamper-evident or security feature is best delivered as an applied label. Equally, a full serialisation line is too much for a contract operation running a handful of SKUs at low volume, where a thermal inkjet and an applied label can meet the same requirement for far less. The honest position is that most pharmaceutical sites run a mix: direct code where it grades best, labels where the format or the surface demands them, and verification on everything because the grade is what gets checked. We will tell you when the simpler option is the compliant one rather than sell you a station you do not need.
Can a serialisation or coding upgrade be grant-funded?
Often, yes. Adding serialisation and verification, or moving from analogue coders to digital laser and thermal inkjet marking, improves quality, traceability and waste, which is exactly the kind of efficiency and compliance investment Malta Enterprise schemes are designed to support. A pharmaceutical line upgrade frequently qualifies for co-funding, provided you apply before you commit to the purchase, which is the one rule that disqualifies most applicants. Our guide to Malta Enterprise grants for coding and labelling walks through which scheme fits and how to keep the application valid. We can provide the itemised quotation and the technical benefit statement an application needs.
What happens when you call us?
- We survey the line. We look at the packs, substrates, speeds, serialisation and verification requirements on your actual line, and the qualification evidence your quality system needs, before we recommend anything.
- We specify and quote. You get a specified, itemised proposal matched to your line and your validation expectations, written so it also supports a grant application if you intend to apply for one.
- We commission, verify and qualify. We install, set up your real serialisation, GS1 and date formats, verify the codes grade on your substrate, support the IQ, OQ and PQ paperwork, and train your operators so the line runs without us.