Sectores
Envases a prueba de manipulaciones para la cadena de suministro farmacéutica
Medicines pass through wholesalers, hospitals, pharmacies and couriers before they reach a patient. Tamper evidence gives every one of those handovers a visible answer to whether the pack was opened.
Used on cartons, vials, pill boxes, controlled drug packaging, cold chain shipments and pallet loads, where the seal must be unambiguous, difficult to replicate and readable by staff under time pressure.
Know what you need? Talk to our team. Not sure what will work? Send us the application.
The problem
Where pharmaceutical packaging is exposed
01
Diversion in transit
Product removed or substituted between wholesaler, courier and dispensing site.
02
Controlled drug handling
High-value or controlled items needing a demonstrable chain of custody.
03
Counterfeit re-packing
Generic tape and plain labels that can be bought and reapplied by anyone.
04
Cold chain conditions
Chilled and frozen shipments where standard adhesives fail on application.
05
Small and curved surfaces
Vials, ampoules and small cartons that leave very little bonding area.
06
Verification burden
Staff needing to confirm integrity quickly, without tools or a full recount.
How it works
What tamper evidence provides, and what it does not
Tamper evident labels and tape separate irreversibly when disturbed, exposing a permanent VOID message that cannot be re-closed to look untouched. They deter interference, reveal it and support verification and audit. They are not a physical barrier and they are not, on their own, a regulatory approval of your packaging.
01
Specified to the pack
Construction, adhesive and format chosen for the substrate, size and storage conditions.
02
Serialised where needed
Numbering, barcodes or QR codes tie a seal to a batch, consignment or custody record.
03
Verified at each handover
Wholesaler, hospital goods-in or pharmacy can see the state of the seal immediately.
Regulatory context
Serialisation, anti-tampering and where UK and EU rules differ
Pharmaceutical packaging security is usually specified against two separate requirements that are easy to conflate. Getting the distinction right is what makes a specification defensible.
| Serialisation and authentication | A unique identifier applied to the pack — typically a 2D Data Matrix carrying product code, serial number, batch and expiry. It tells you which pack this is, and allows it to be checked against a repository. |
|---|---|
| Tamper evidence | A physical device on the sealed pack that separates or voids irreversibly when disturbed. It indicates whether the sealed pack appears to have been opened or interfered with since it left the packing line. |
| How they work together | They are complementary, not alternatives. Serialisation identifies the pack. Tamper evidence indicates interference with the sealed pack. A pack can carry a valid unique identifier and still show clear evidence of interference — which is precisely why both jobs are specified separately. |
United Kingdom
Since 1 January 2021 the UK does not operate the EU Falsified Medicines Directive verification system, and the FMD unique identifier and repository obligations are disapplied for medicines placed on the UK market. The MHRA has continued to encourage manufacturers and packers to keep anti-tamper packaging in place, and many UK supply chains have retained it as good practice and as a contractual requirement from wholesalers, hospitals and retailers. In practice, tamper evidence in the UK is specified on operational and commercial grounds rather than to satisfy a UK verification scheme.
European Union
For medicines placed on the EU market, the safety features required under the Falsified Medicines Directive remain two distinct things: a unique identifier for identification and verification, and an anti-tampering device that allows the pack to be checked for whether it has been opened or altered. The two are specified, applied and verified separately.
ISO 21976 and technical standards
ISO 21976:2018 Packaging — Tamper verification features for medicinal product packaging is the relevant international standard describing tamper verification features and how they are assessed. It is a useful specification reference when you are writing a brief or comparing constructions. We use it as a technical reference point; we do not present it as a certification of TamperTech products, and no seal — ours or anyone's — makes a pack compliant on its own. Compliance sits with the marketing authorisation holder and the packing operation.
What this means when you specify: tell us the pack, the substrate, the storage conditions and what has to be evident at each handover. We will specify the construction and, where you need it, the numbering or 2D code that ties a seal to a batch or consignment record.
Key applications
Pharmaceutical security applications
Applications across dispensing, distribution and cold chain where verification is checked.
Pill Box and Carton Seals
Paper seals for pill boxes and cartons that show interference before the patient opens the pack.
View solution →
Vial Secure Labels
A numbered seal wrapped over the vial closure, tying a vial back to a batch or dispense record.
View solution →
Controlled Drug and Tote Security
Numbered, non-residue tote seals for controlled drug and prescription movements.
View solution →
Insulated Box Seals
Cold chain seals for validated shippers carrying temperature-sensitive medicines.
View solution →
Seguridad en la gestión de residuos clínicos
Closure evidence on clinical waste containers between point of use and collection.
View solution →
Custom tamper evident labels
Numbering, barcoding and die-cuts specified around your pack and process.
View solution →
Something not on this list
If your pack, surface or operation is not covered here, send us the pack and the problem and we will specify it.
Put it through the Security Lab →Start here
What are you sealing?
Pharmaceutical tamper evidence is decided by pack format, surface and storage temperature — not by industry. Start from the thing you are actually sealing.
Medicine carton or pill box
Folding cartons and pill boxes in coated, varnished or recycled board. Flap and end-seal placement, and constructions that void without lifting board fibres.
Vial, ampoule or closure
Small-diameter and curved surfaces, over-cap and closure seals, and legibility of the void message on limited label real estate.
Injection pen or syringe carton
Pre-filled pens, auto-injectors and syringe cartons — including high-value refrigerated products such as GLP-1 presentations, where the pack is small, cold and diversion-exposed. Usually a bespoke size and adhesive specification.
Controlled-drug tote
Reusable totes and CD containers moving between dispensary, wholesaler and ward, where custody handovers need to be visible and recordable.
Insulated or cold-chain shipper
2–8 °C and frozen shipments, EPS and insulated liners, condensation on application and a void message that still reads after refrigerated transit.
Pallet or transit load
Wholesale and distribution loads where the unit of evidence is the pallet or outer case rather than the individual pack.
Not sure which applies, or sealing something not listed? Send us the pack and we will specify it around your operation.
Products typically specified
What pharmaceutical operations usually specify
Carton and case tape
Standard tamper evident tape for outer cartons and shippers.
Cold chain shipments
Cold chain constructions for temperature sensitive product.
Serialised and custom
Custom labels with numbering, barcodes and bespoke artwork.
Specifying it in practice
The decisions pharmaceutical packaging security actually turns on
Most pharmaceutical enquiries reduce to four practical questions: what the seal has to prove, where on the pack it sits, whether it has to be individually identifiable, and whether it will survive the conditions the pack travels through.
Tamper evidence or authentication?
- Tamper evidence answers "has this pack been opened since it was sealed?" — a checkable signal at each handover, readable by the person receiving the pack.
- Authentication answers "is this pack ours?" — covert features, custom security messaging and unique numbering that a re-packer cannot casually reproduce.
- They are different jobs and are often specified together: an overt seal that anyone can check, plus a feature only your team knows to look for.
- Neither confirms the identity or condition of the product inside the pack.
Where does the seal sit?
- Carton and outer case closure — tape across the closure, so interference shows on the board itself once the tape is lifted.
- Pack and container closure — small-format labels across carton flaps, pill boxes, bottle and jar closures, and dumbbell formats around vial necks where a rectangle will not sit.
- Tote, cage and cabinet — controlled drug handling usually needs a seal that can be logged, then removed cleanly from a reused container.
- Reusable containers point to non-residue; single-trip packs point to permanent transfer.
Does each seal need to be identifiable?
- Sequential numbers and barcodes let a seal be recorded at closure and verified at receipt — which is what turns a seal into an auditable handover rather than a visual impression.
- A dual number tab lets the number be retained on a docket while the seal stays on the pack.
- Numbering is only evidence where the number is actually captured and checked. Without both ends of that record it adds cost and no assurance.
- Where serialisation already exists on the pack, the seal should complement it, not duplicate it.
Will it survive the journey?
- Substrate first: coated carton board, varnished print, PET and HDPE closures, glass vials and powder-coated steel all behave differently, and application temperature matters as much as storage.
- Chilled and cold-chain packs must be sealed and then tested at the temperature they are actually applied and removed at — bond and transfer behaviour both change.
- Condensation, gloves, abrasion and cleaning agents all affect whether numbers stay scannable.
- Test with your real application method — hand, applicator or line — before a specification is fixed.
What tamper evidence does not do: it does not certify contents, quality or chain of custody, it does not make a pack tamper-proof, and it is not a substitute for your own goods-in verification or your regulatory assessment. What it does is make interference visible and checkable at the point where a pack changes hands.
- Tamper evident label rangeConstruction detail for permanent, non-residue and paper label formats.
- Tamper evident tape rangeCarton and outer case closure constructions, including numbered and covert.
- Send us the pack — The Security LabSend the pack, the closure and the conditions; we test it and tell you what actually works.
Specification
Pharmaceutical seal specification
A pharmaceutical seal is specified in one order: pack format, substrate, evidence mechanism, application temperature, service temperature, identification and print, sample and approval, then a repeatable specification. The figures below are the verified construction data behind those decisions.
1. Pack format and substrate
| Sizes — supplied examples | Examples of formats we already supply, not size limits: 85 x 25 mm and 70 x 30 mm for cartons and outer packs; 25 x 12 mm paper seals for dispensed pill boxes; a 70 x 12 mm dumbbell format for vials and closures; up to 240 x 40 mm two-part numbered formats for totes and cases. |
|---|---|
| Custom sizes and shapes | Label size, shape and die are made to the application — the examples above are starting points rather than a catalogue you have to choose from. Tell us the pack and the closure and the format is specified around it. |
| Supply format | Supplied on rolls, 76 mm (3") core; roll length and labels per roll specified to the order. |
2. Evidence mechanism and temperature
Application temperature, service temperature and storage are three separate figures and are kept separate here. A construction rated for cold storage is not automatically suitable for application onto a cold, wet or condensing surface.
| Permanent (BOPP) VOID transfers to the pack | Application: approved between 0 °C and 12 °C — the surface must be dry. Service: works down below −80 °C. Storage of unused stock: dry conditions, 10–20 °C (50–68 °F), kept in the box and out of direct sunlight. 50µ BOPP film, formulated hot-melt adhesive. Used on carton board and similar surfaces. |
|---|---|
| Non-residue (X22) Lifts cleanly, message stays on the label | Application: recommended +15 °C to +25 °C, applied by hand and rubbed down. Storage of unused stock: dry, 10–20 °C, in the box, out of direct sunlight. 50µ polyester film, acrylic adhesive. Not designed for use on cardboard, and not designed for food contact. Void quality depends on the surface, so it is always evaluated on your own pack. |
| Cold-chain construction Separate route, not a variant of the above | Where the pack is sealed cold or held frozen, a cold-chain construction is specified for both cold application and cold storage, designed for 15 °C down to −80 °C, with tamper evidence retained at low temperature. Cold-storage suitability does not mean a label can be applied reliably onto a wet or condensing surface. Condensation, frost, ice crystals, wash-down of returnable containers and gloved handling all change adhesion and legibility, so the surface state at the moment of application is specified separately and tested through a representative temperature cycle. |
3. Identification and print
| UV flexographic spot colour printed to a Pantone reference, including custom VOID and security-message wording. | |
| Numbering and codes | Sequential and consecutive numbering, alphanumeric and human-readable; Dual Number Tab paired numbering where the number is retained with the paperwork; barcodes, QR codes and Data Matrix. Surface or sub-surface — sub-surface where the code has to survive abrasion and the journey. |
| Where responsibility sits | We print the code you supply. The serialisation system, number allocation, repository connection and data workflow remain with the customer or marketing authorisation holder. Printing a code is not serialisation and does not make a pack compliant. |
4. Sample, approve, repeat
| Minimum order quantity | Confirmed against the specification. It varies by construction, size and print or numbering, so we confirm it with the quotation rather than quote a general figure. |
|---|---|
| Lead time | Confirmed with the specification. Bespoke print, numbering or new die work sits above a standard construction, and sampling sits ahead of the production lead time. |
| Documentation available | Product data sheet (film, thickness, adhesive data, application, storage, shelf life); size, die and specification detail; adhesive and material information; samples for approval, with a record of what was tested and how it behaved; copies of current certificates on request. |
| Shelf life | 12–18 months from manufacture is the recommended figure, stored as above. |
| Repeat specification | Construction, adhesive, die size and print are specified and recorded under our ISO 9001 quality system, so a repeat order matches the approved original. |
Manufacturing and certification
Tamper Technologies Ltd holds ISO 9001 for quality management, ISO 14001 for environmental management and ISO 45001 for occupational health and safety, and holds an EcoVadis Silver medal for independently assessed sustainability performance. Manufacturing, converting, printing and quality control take place at our site in Ashbourne, Derbyshire, with a European distribution hub in Poland supporting EU customers. Certificate copies are available on request. Regulatory suitability for a specific pharmaceutical product or market depends on the application — tell us the requirement and we will confirm what we can support. Detail is set out on the accreditations page.
Specifying it properly
What we need to know to get it right first time
Substrate and geometry
Coated carton board, glass, polypropylene and foil all bond differently, and a curved vial gives you very little area to work with. Send us the actual pack rather than a drawing.
Storage and application temperature
A construction rated for cold storage is not the same as one rated for cold application. Tell us the surface temperature at the moment the seal goes on.
Verification and audit expectations
Whether you need numbering, barcodes, tie-in to a batch record or simply an unmistakable visual check changes the specification significantly.
Regulatory scope
We specify and manufacture the tamper evident construction. Assessment against the regulations that apply to your product and market remains with you and your quality team, and we will support the technical evidence you need for it.
Next step
Specify it around your operation
Pharmaceutical seal problems are usually surface, size or temperature problems. Send us the pack, the conditions and the verification you need and we will specify it with you.
Known requirement
Samples, pricing, artwork and rollout for a product or application you have already identified.
Not sure what will work
Difficult substrate, temperature, line speed or a loss pattern you cannot pin down. Send us the pack and the problem.