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Application · pharmaceutical

Pharmaceutical label materials: what the specification asks for

Pharma labels are small, printed with variable data, applied at speed onto cartons and vials, and read by a scanner that has one chance to get it right. The material has to make that easy — and the compliance questions have to be answered before the first pallet, not after.

Model guide · last verified 2026-10-21 · published in English · technical questions: contact the lab

Short answer. For secondary packaging, specify a smooth paper or white film with a permanent adhesive sized for small-format die cutting, and verify that your thermal-transfer or laser coding bonds to the surface you chose. For tamper evidence, a VOID construction is a different product, not a variant. On documentation we are precise rather than optimistic: the compliance pack is agreed project by project, so raise it in the first email and we will confirm in writing what we can issue for the construction you need.
115 constructionsMOQ 1,000 m²Lead time 15-25 daysFree samples & TDS

Four requirements that come before "which material"

Pharma purchasing usually starts with a material code from an approved supplier list, which is the right instinct. If you are specifying from scratch, these four decide the construction long before price does.

Format and die cutting. Small labels on small rolls mean the die-cut depth window is narrow and the liner has to be consistent from roll to roll. A 54 gsm glassine is cheap but leaves little margin at high speed.

Variable data. Lot, expiry and serialisation codes are added after printing, by thermal transfer, laser or inkjet. Each needs a different surface: thermal transfer wants a smooth, non-absorbent topcoat, laser coding wants a surface that ablates cleanly, and 2D DataMatrix codes need enough contrast to verify at grade B or better.

Tamper evidence. A VOID construction leaves a visible message when the label is lifted. It is a separate product with its own release behaviour, not a permanent label with a different name.

Documentation. This is where most cross-border pharma projects stall. See the section below — we would rather lose the order at the quotation stage than at the audit.

Pharmaceutical cartons and vials labelled with small-format self-adhesive labels
Small format is the defining constraint: the die-cut window and the code are what fail first.

Constructions that fit secondary packaging

The codes below are the ones our converters use for cartons, vials, ampoule trays and device labels. Facestock and adhesive are as stated on the TDS.

CodeFacestockAdhesiveLinerWhere it fits
FL0101W2170 gsm woodfree paperHot-melt54 gsm white glassineSmall carton labels, high-volume, cost sensitive
FL0106W2190 gsm high-glossy cast coated paperStrong adhesion hot meltT-type 54 gsm white glassineSmooth face for thermal-transfer coding where the code must not feather
UV0101W21140 gsm semi-glossy cast coated paper23 ± 3 mic60 gsm white glassineDigital short runs and trial batches
MJ0401W2175 mic glossy white PET filmWater-based permanent acrylic80 gsm glassineDevice labels that need a film face and stable dimensions
LJ0101W21140 gsm semi-glossy cast coated paperWater-based95 gsm white linerLaser/LED printing of variable data in-house
NE0103W2125mic matte silver VOID security filmOil glue80gsm white glassine linerTamper-evident VOID construction; leaves a visible mark when lifted

For vial and ampoule labels, tell us the diameter and the line speed: the curvature and the applicator decide more about the construction than the print method does.

Glossy white PET self-adhesive film labelstock roll for device labels
PET holds dimensions through coding and sterilisation cycles where paper would cockle.

How to choose

Choose by the coding method first, because it is the hardest requirement to change later, then by format and tamper requirement.

If this is your situationStart withBecause
Thermal-transfer lot/expiry on a paper carton labelFL0106W21 — 90 gsm high-glossy cast coatedA level, smooth face is what keeps small codes from feathering
In-house laser printing of variable dataLJ0101W21 — 140 gsm semi-glossy paperHeat-stable paper built for toner fusing, not ink absorption
Film device label, stable dimensionsMJ0401W21 — 75 mic white PETPET does not stretch or cockle; codes stay in register
Tamper-evident seal or security labelNE0103W21 — VOID constructionA different release mechanism; it cannot be substituted with a permanent grade
Short development batch, digital pressUV0101W21 — 140 gsm semi-glossy paperAvailable in small quantities without a flexo run
Sheeting line preparing self-adhesive labelstock in sheet format
Sheet formats suit trial batches and laser-printed variable data before a roll commitment.

The honest part: documentation

Pharmaceutical and food-contact projects are decided by paperwork as much as by material. A migration statement, a food-contact declaration or a pharmaceutical compliance pack is issued against a specific construction and a specific regulatory framework, and it is the material supplier who issues it.

We publish full technical data sheets — facestock, adhesive chemistry class, liner, coat weight and the five batch tests. Compliance documentation is issued against a construction and a framework, not per company, so raise it in the first email and we will state in writing which of the following we can put our name to for your case:

EU — a Declaration of Compliance for the plastic layer under Regulation (EU) 10/2011, inside the framework of 1935/2004. The DoC travels down the supply chain, so ours carries our raw-material suppliers' declarations plus our own statement of the construction actually shipped. USA — a statement of compliance for the adhesive with 21 CFR 175.105 and for the paper component with 21 CFR 176.170 (aqueous and fatty foods) or 176.180 (dry foods); a 175.105 clearance is not an EU passport, and the reverse is equally true. Germany — reference to BfR Recommendation XXXVI (paper and board for food contact) where the base paper carries it, which is the reference most European converters ask for. China — GB 9685 additive compliance for the adhesive and coating layers.

One date to have on the radar: since 12 August 2026 the PFAS limits in PPWR (EU) 2025/40 Article 5(5) apply to food-contact packaging placed on the EU market — 25 ppb for any single PFAS, 250 ppb for the sum, 50 ppm total fluorine — and they cover adhesives and coatings, not only the paper. There is no stock-exhaustion period. We ask our paper, polyethylene and adhesive suppliers for a PFAS statement, and we will tell you which of the three routes (supplier statement, total-fluorine screen, or third-party test report) we can supply for the construction you need.

If we cannot meet the requirement we will tell you — discovering it at audit is the expensive version of the same conversation.

What we can support immediately: the TDS set, retained samples for the life of each batch, and a documented answer if a batch performs differently from the sample you approved.

Four failures we are called about

On small-format work, most complaints are about the code, not the label.

The DataMatrix will not verify at grade B

Symptom: codes scan on paper, fail on film, or drift within a run. Cause: dot gain or low contrast between the code and the face. On a glossy film with a dark print, contrast is usually the issue, not resolution. Fix: test the actual code on the actual face — we send samples for exactly this, and it takes a day.

Adhesive oozes on small rolls

Symptom: sticky edges, labels that will not release, residue on the applicator. Cause: small labels mean high winding tension per unit area, and a soft adhesive migrates at the edge. Fix: check slitting and tension, then consider a firmer adhesive rather than a softer one.

The VOID message does not appear

Symptom: the label lifts with no visible message. Cause: the label was applied too cold or with too little pressure, so the tamper layer never bonded to the carton. Fix: check application conditions; a VOID construction needs real contact to work — it is a two-surface system.

Curling on a small-diameter roll

Symptom: labels lift on the roll before use. Cause: the construction is too stiff for the roll diameter; a thick film on a heavy liner will not lay flat at 40 mm. Fix: thinner facestock or a lighter liner — this is a geometry problem, and no adhesive change solves it.

Questions buyers ask before ordering

Answered by the coating and conversion team, not by marketing.

Do you supply food-contact or pharma-compliant label material?
We supply the labelstock and publish full TDS. Compliance documentation — a migration statement or a pharmaceutical declaration — is agreed project by project, because it is issued against a specific construction and regulatory framework. Raise it before sampling and we will confirm in writing what we can issue for your case.
Which material is best for thermal-transfer lot and expiry codes?
A smooth, level face — our 90 gsm high-glossy cast coated paper (FL0106W21) is the usual starting point. Feathering on small codes almost always traces back to a rough or unevenly coated face.
Can you supply VOID tamper-evident labelstock?
Yes — NE0103W21 is a VOID construction on a 25 micron matte silver film face with an 80 gsm white glassine liner. Note that VOID depends on adequate application pressure and temperature to bond its tamper layer.
What causes curling on small-diameter rolls?
Geometry. A stiff film on a heavy liner cannot lay flat at a small roll diameter. Thinner facestock or a lighter liner is the fix; changing adhesive does nothing.
Can I get small trial quantities for validation?
Yes, from a few hundred metres; standard MOQ is 1,000 m². Validation batches are exactly the case for pilot quantities, and samples plus TDS are free.
Do you print the labels as well?
No. We are a material manufacturer — we coat and laminate labelstock, and converters print it. That separation is deliberate: it keeps your print specification and your material specification independent.
Keep reading

Related guides and material families

Next step. Send the container, the print engine and the label life. We reply with a construction recommendation, the TDS for each code and a free A4 sample set — normally within one working day.
Request samples and TDS All 115 constructions
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