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Pharmaceutical products with precise labels and a multilayer construction for the package insert

Pharmaceutical Industry

Every piece of data on the label has to be legible, accurate, and durable.

A pharmaceutical product label has to meet strict accuracy requirements: small print legible at a glance, a barcode that scans without error, and identical colors from the first label to the last in a print run of a million units. A multilayer label with a duplex or triplex construction provides an additional layer of space for the package insert and reduces the need for a separate leaflet in the packaging. Servo registration on the MPS machines and 100% inspection on the Rotoflex machines guarantee the precision the pharmaceutical industry requires.

Industry Requirements

What the pharmaceutical industry requires from a label.

Zero tolerance for error. Every piece of data, every barcode, and every label in the print run has to be identical and legible.

Small-Print LegibilityActive substances, dosage, expiration date
100% Inspection on Rotoflex MachinesA camera checks every label in the run
Multilayer for the PILDuplex or triplex construction, additional space for the package insert
Resistance to Alcohol and DisinfectantsHospital and pharmacy environments
Precise Barcode ReproductionEAN, DataMatrix, QR without error
Consistent Quality Across the Full RunServo registration, the first label identical to the millionth
Multilingual DeclarationActive substances, dosage, warnings
ISO 9001 Certified ProcessesDocumented quality, traceability
Your Challenges, Our Solutions

Three Problems You Face

01Your Challenge
The small print on the medication bottle is illegible, and the active substances are barely legible. The barcode fails to scan correctly on one in ten bottles.

Crisp.Dot HD print, servo registration, and 100% inspection on Rotoflex machines

Crisp.Dot HD flexo technology on the MPS machines reproduces text below 6pt with sharp edges. Servo registration keeps color positioning constant across the whole print run. Every label passes visual inspection on a Rotoflex DSI-330 with cameras that detect defects, shifted barcodes, and missing labels.

Crisp.Dot HD 100% Inspection Servo Registration
Small print, sharp and legibleActive substance names, dosage, expiration date, warnings. The Crisp.Dot HD process with a fine screen structure produces sharp letter edges even at 5pt font size.
Barcode scannable on every labelEAN, DataMatrix, and QR codes. Servo registration guarantees position, and 100% inspection on the Rotoflex machines verifies scannability. A defective barcode is detected and removed from the roll.
Star Proof before printingYou approve text legibility, barcode positions, and color accuracy before the machine starts. Saved settings guarantee an identical result on repeat print runs.
Two Rotoflex DSI-330 machines with MMLD detection. Every missing or shifted label is removed automatically.
02Your Challenge
The package insert (PIL) takes up more space in the carton than the product itself. Printing a separate leaflet costs money, and the packaging ends up bigger than it needs to be.

A multilayer label reduces the need for extra space for the insert

A multilayer label with a duplex or triplex construction adds an extra layer of space directly on the bottle, using a Cross-Over system for delamination and relamination on the MPS EF 340. Part of the insert content can fit in that extra layer, reducing the need for a separate leaflet in the packaging. The patient opens the extra layer of the label, reads the text, and puts it back in place.

Multilayer PIL Duplex/Triplex MPS EF 340
Part of the insert content in the extra layerBasic information such as the active substance, dosage, and key warnings can fit in the extra layer of the label. Whether the extra layer can fully replace a separate leaflet depends on the length of the PIL text and the applicable regulations for the specific product and market, and this is checked case by case.
Less dependence on a separate leafletWhen the extra layer of the label covers part of the insert content, the carton can sometimes be smaller, which affects transport and storage space. The actual savings depend on the product and the market.
Cross-Over on the MPS EF 340The extra layer is integrated into the label in a single pass through the Cross-Over delamination and relamination system. A finished roll of complete multilayer labels ready for your applicator, with no separate assembly step.
A multilayer label is an option for OTC products, supplements, and veterinary preparations. Whether it's sufficient for a given product and its regulatory requirements is something we check together before starting prepress.
03Your Challenge
The same medication ships to five markets, and each has different regulatory requirements for the declaration. I keep five label versions on hand and keep sending out the wrong one.

A multilayer label with an added language reduces the number of separate versions

A multilayer label with a duplex or triplex construction lets you add one additional language to a single label alongside the primary one, instead of a completely separate version for each market. The medication name, active substance, and barcode on the outside stay unchanged. The extra layer carries the text in the added language, which reduces the number of separate label versions and simplifies warehouse operations.

Added Language Fewer Versions Multilayer
Neighboring markets with similar requirementsFor markets with closely related languages and similar regulatory requirements, a duplex or triplex construction can add one additional language to the same label. How many markets fit on a single label depends on text length and the specific regulations, and this is checked for each product individually.
Fewer versions in the warehouseFewer versions in your ERP and warehouse mean a lower risk that the wrong label ends up on the wrong market. Logistics is simpler with fewer separate items to track.
Legible text in the added languageThe extra layer of the label provides room for the text in the added language to stay legible, without shrinking the font below an acceptable size. Prepress checks legibility before printing for each language.
An open-close (peel-and-reveal) label is an alternative when you only need a short amount of additional text in one language.
Frequently Asked Questions

Labels for the Pharmaceutical Industry, Your Questions

Questions about print precision, multilayer PIL solutions, material resistance, and the ordering process.

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Crisp.Dot HD flexo technology reproduces text below 6pt with sharp edges. Star Proof before printing shows the actual appearance. Servo registration keeps the position constant. 100% inspection on a Rotoflex DSI-330 detects any legibility defect.

Yes. Two Rotoflex DSI-330 machines with the URC 2.0 system and cameras check every label. MMLD detection catches missing and shifted labels. Defective ones are removed automatically. Up to 305 m/min with no compromise on precision.

Yes. Servo registration automatically corrects color position in real time. The first label is identical to the millionth. iControl continuously monitors print quality. 100% inspection on the Rotoflex machines removes every defective label before delivery.

Yes, partly. A multilayer label with a duplex or triplex construction adds an extra layer of space directly on the bottle, which can hold part of the PIL content, for example the active substance, dosage, and key warnings. Whether the extra layer can fully replace a separate leaflet depends on the length of the PIL text and the applicable regulations for the specific product and market, and we check this case by case.

A multilayer label has a duplex (2-layer) or triplex (3-layer) construction, a significantly smaller capacity than a full folded PIL insert. In practice, that fits the core declaration plus one additional language or a shortened warning text, and the exact amount depends on font size and text length for the specific product. The MPS EF 340 with the Cross-Over unit integrates the extra layer into the label in a single pass.

Partly. A multilayer label with a duplex or triplex construction can add one additional language alongside the primary one, which reduces the number of separate versions for markets with similar regulatory requirements. For five fully distinct markets and languages, you'll still realistically need more than one label, but fewer versions than today. An open-close label is an alternative when you only need a short amount of additional text in one language.

Yes. PP or PET with a UV coating and lamination withstands wiping with alcohol and contact with disinfectants. The print doesn't fade, and the adhesive doesn't fail. For autoclaving, we use PET with a specialty high-temperature adhesive.

Yes. Supplements and OTC products have specific regulatory requirements: health claims, dosage, warnings, allergens. A multilayer label is an option when you need extra space for part of that content without a separate leaflet. Premium options (embossing, cold foil, spot varnish) are available to stand out on the pharmacy shelf.

Standard printed labels, 5-7 business days. Multilayer labels, 10-14 business days. Repeat print runs, 3-5 business days. Six machines in operation and two Rotoflex inspection machines provide capacity with no waiting.

The type of product (medication, supplement, OTC, veterinary), the packaging type (bottle, tube, carton), the label dimensions, whether you need a multilayer label with an extra layer for PIL content, the number of languages, whether you need pre-printed labels for variable data (expiration date, lot, serial number), the print run, and the deadline. You'll receive a quote within 24 hours.

Zero Tolerance for Error

Every detail legible,
every label inspected

Describe your product, packaging, and regulatory requirements, and we'll deliver legible text, a scannable barcode, and a consistent look across every label in the run. A multilayer label with a duplex or triplex construction adds extra space for PIL content and an additional language. Every label goes through 100% inspection before delivery.

100% Inspection on Every Label Quote Within 24 Hours ISO 9001 Certified Processes
Crisp.Dot HD and 100% InspectionSmall print stays sharp down to 5pt. Every label is checked by camera. A defective barcode is automatically removed from the roll.
Multilayer PIL, Duplex or TriplexThe extra layer carries part of the PIL content directly on the packaging. It reduces the need for a separate leaflet in some cases, depending on text length and the applicable regulations for the target market.
Resistant to Alcohol and DisinfectantsPP or PET with lamination for hospital and pharmacy environments. The print doesn't fade when wiped with alcohol.
Fewer Versions for Related MarketsA multilayer label with an added language reduces the number of separate versions for markets with similar regulatory requirements, lowering the risk of a version mix-up and simplifying logistics.
ISO 9001Certified
Quality
100%Inspection on
Every Label
6Printing Machines
in Operation
24hQuote After
Inquiry Received
35+Years of Experience
in Flexo Printing