There are times when you needto give a shape to your dreams,and when one must be onebecause it cannot be otherwise.Times when everything we domust be safe, effective and reliable.And above all it must be ....

...without side effects.

We are a leading converter of labels, cartons, flexible packaging and printed materials for consumption. And we have been since 1986. Today, after investments, acquisitions, expansions and enthusiasm, we are a large packaging group with a specialized division for the pharmaceutical industry. We are an industrial company that offers the experience of a team of over 250 people including technicians, engineers, graphic designers, product managers, skilled workers and designers to develop solutions using cutting edge technology. We supply all types of printing in a wide range of materials.

About us

+250

+40

24/7

14

4

4

0%

35%

15

resources between professionals and technicians operating at various locations

printing machines withall the technologies including digital

graphics workstations handled with ESKO management system

production sites,a total of

sq.m.

resources for quality management

CTP Kodakconstant backupof printing plants

defects policy

free productive capacity

50.000

taking careof our customers

For us, safety is not a choice: it is in our DNA.Because of this, we have developed our stringent procedures,in-line and off-line production tests and a system that encompasses every individual moment of our production operations within a 100%-protected production process. This is Pharma Mentis, a model that has been designed to ensure the absolute safety of our medical products and the highest possible quality of our packaging. Above all, it is one that is capable of safeguarding the health of our patients.

For each division, we constantly invest incutting-edge technologies in order to automatically monitor our print work. From the instant our print tools are prepared right up to the time the batch is released, we constantly check compliance with specification requirements to ensure our qualityis always 100%.

We ensure that a pharmaceutical product is authentic by means of tamper-evident solutions and specific serialisation projects along the entire supply chain. Through our Nuceria Lab, we are constantly providing integrated solutions capable of effectively providing a response in the fight against drug counterfeiting.

Pharma Mentis

procedures

control

security

All our resources have been set up in keeping with a culture well-rooted in line clearance, and that complies with GMP (Good Manufacturing Practice) to avoid any kind of contamination of the products on the production lines. We ensure our documentation meets the requirements of traceability for every print batch.

Syrup, pill, or syringe: the right labelfor every step in the treatment.Labels for the pharmaceutical sector must have optimum performanceas regards flexibility, so they can be adapted to even small diameter syringes and vials. Furthermore, they must conform to the technical specifications for critical applications like the low temperatures for all sterilisation procedures. We identify the most suitable material for every application surface, be it glass or plastic or even, in particular, siliconized surfaces. We protect your products from all risk of contamination by using ISEGA -certified adhesives as well as low migration inks.

Label

We label vials, syringes and ampoules with diameters of up to 10-50mm. We also print using silkscreen printing technology to obtain maximum readability on clear-on-clear media. We are able to detect whether labels have not been applied correctly using special photocells in the packaging phase to ensure high application speeds.

We have dedicated production lines for special combinations, as well as the technical know-how for hang labels (even multi-page varieties) that ensure their ability handle the weight of 10 to 1000ml bottles.

• Sterilisation at 121ºC for 45 min• Centrifuge-based processing•Freezing at -80ºC for 24h •Thawing in water at circa 60º

We print labels using specialist inks and suitable materials that can withstand the following process conditions:

We ensure high performance even at very low temperatures with innovative long-lasting adhesives that can even handle freezing to below 196°C,and labels that are capable of resisting special chemical products and autoclave sterilisation procedures.

labels for drugsto be administeredby injection

hang label

blood bags

cryogenic applications

multiple pages and peel-off

We understand the need to increase the shelf appeal of Over-The-Counter (OTC) products by maximising the surface area that can be printed. We produce any type of print finish, even with Braille, for peel-off and multi-page labels (with upto 10 sides)

proceduresFacilities and production lines dedicated to producing labels for the pharmaceutical sector ensure that anti-mix-up flows are complied with. Furthermore, on our presses, we can directly produce special data matrix outside the print areas in order to check that the print output conforms to the master artwork. In the light of the spread of optical readers, we are promoting the reading of these codes with a view to ensuring better control of traceability and reducing manual checking operations.

controlWe manage the pre-printing phase with Esko software to automatically set up theprint tools.

Using a BST Shark Lex 4000 inspection system, we can ensure that 100% checks are carried out on 100% of the processes on all our production lines.

During printing runsWe have the ability to run real time checks on all batches and to visualize the main defects such as register errors, dirt marks, scratches and incomplete or missing text fast. Using specific PDF Comparison software, our operators can check to see if the processed code has been correctly identified.

During the packaging process, bidirectional logic control tables continuously ensure that a double inspection is carried out on print work. If manual corrections have been made by the operator, the production line automatically ensures that the roll is rewound so a further check is carried out by the machine operating software.

securityWe protect your brand using several safety solutions:

Overt technology:visible to the naked eye

Void FilmsLeaves an irreversible VOID message (alphanumeric or geometrical) when the label is detached from the label face.

HologramsMicro-embossed metalized paper with 2D/3D diffraction patterns.

Customized Security PapersSpecial Fibre watermarks or additives can be integrated into the label material.

3-D FilmsThanks to a patented process, printed images can be placed so that they seem to disappear or move when the pack is inclined or rotated, thereby ensuring that they are totally unrepeatable.

Covert Technology: visible only by means of a security device

Infrared Taggants IR could bead-ded to paper, inks and varnishes.

LabelPharma mentis

Blister packs, vials and sachets: appealand safety in just one pack.We design glued cartons for all pharmaceutical formats, and also select materials from FSC- [Forest Stewardship Council] and PEFC- [Programme for the Endorsement of Forest Certification] controlled supply chains to ensure maximum efficiency on our print lines and fulfil the need to protect our product. Using our dedicated Computer-aided Design Software, we are able to prepare special designs, even with integrated solutions, to automatically produce blister packs, vials, bottles and sachets. Tamper evident seals together with special finish prints combine the need to protect a medicinal product with maximising its shelf appeal.

Folding

A special internal pocket makes it easy to automatically store leaflets. Furthermore, a simple push out allows a patient warning sheet to be removed.

We produce cartons with special dividers for multi-pack solutions. Slots suitable for even very small vials allow products to be removed easily and protected, for clinical tests too.

These are products that are the result of creative solutions. They combine the technologies and know-how of our various divisions. Our automated systems allow us to apply all kinds of special label that make it easier for patientsto take their medication.

With an outside flap, separated for additional information regarding the patient compliance, we produce special perforations to facilitate the removal of the card without compromising the integrity of the medical device.

We can print all types of linear carton using both conventional and UV technology. We can ensure maximum line speed via automated checks in keeping with the best performance levels in the final packaging phase.

shell packs®

easy packs

daily packsfly packs®

standard folding boxes

Product features and options• Board trays for fragile parenteral containers• Carton and label combination• Carton and leaflet combination• Hot in-house foiling• Window-patched cartons• Cartons with braille• Embossing and debossing• Microflute paper• Label application and dedicated serialisation line

proceduresTogether with in- and off-line inspection systems, there is also an inherent company culture of respect for line clearance, which is in keeping with the GMP regulations to be applied for each production phase, thereby avoiding any product mix upson production runs.

controlThe pre-print phase is handled via Esko software together with in-line density and spectrophotometry checks using Heildeberg Color Assistent Pro. These guarantee print repeatability for each batch. Electronic checks, using the Bobst Power Register system, ensure accurate hole punching during the die-cut process.

An integrated system “Xtend” by Baumer HHS, installed on all our gluing lines, reads all the bar codes, monitors the glue, registers and ejects all defective products by means of an automated system. Based on an “inverse logic” principle, packaging is considered to be “non-compliant by default” and only advances along the line for definitive validation if it passes the pre-set checks. The code readers, therefore, check all the products on the line and compare their characteristics with the input ones, unequivocally identifying the batches to avoid any possible confusion between different product lines.

FoldingPharma Mentis

security

We offer solutions for card board printing with security features that are invisible to the naked eye:

Micro-lettering

Wood inks, which can be only be detected by means of special UV light equipment.

Micro perforation systems from cardboard for tamper evident closures, also in combination with security labels.

In keeping with EU Directive 2011/62/EU we propose integrated solutions that ensure:

• Absolute product authenticity

• Univocal identification of each individual package

• Product integrity

To ensure our lines comply with, we provide support via a dedicated team and carry out inspections together with our supply chain partners.

PublicationEU Directive2011/62/EU

2011 2012 2013 2014 2015 2017 2018 2019

2016

Adoptdelegate act

Implementationact requirementsready

Complete overt.covert and anticounterfeitingrange ready

A

B C

A. Folding box flaps closed with glue, with a combination of cold and hot technology. Advantages of Hot Glue: fast adhesion, simple to apply. Advantagesof Cold Glue: irreversible pack closure

B. Specially-constructedself-destructing boxes

C. Sealing labels and tapes (Fibre-tear seal, VOID seal, Strips or perforation, Fragile material used)

Pack violation and brand-abuse cases have increased in all supply chain phases. Making use of the technical know-how of our division, we are able to offer innovative personalised integrated solutions in the fight against counterfeiting. A technical team with production line support is dedicated to listening to all your requirements and identifying the most effective solution. From a seal to a carton, to printing micro-lettering, there are no limits to safety applications.

Protect your brand security solution

The anti-counterfeitingprocess

We understand the safety characteristics that a product must have

We establish the most suitable solution compatible with your production lines.

We define the level of protection for basic highly-personalised products to be offered.

From the factory to the patient:we take care of everything used to treat themFor each application, even on cartons that have already been printed,we can apply serialised labels with an automated line dedicated to release a final reconciliation. Using our up to 720dpi UV-print technology, we can produce highly-legible print work for even small sized products. Production line monitoring systems (Cognex video cameras) electronically check the ID code, grade and Optical Character Verification (OCV), recording the results of these checks on a specific database for final releaseas a record for every batch.

Technical specification:Print resolution up to 720 dpiMinimum size Barcode element: 0,169 mmBarcode type: Code 128CRegarding grade in compliance with ISO/IEC 15416

Quality control:Inspection System in line that occur:Presence of Chinese E-CodeGrade regardingStructure and Dimension

Serialization

Reliable, safe and flexible.Oral solutions, capsules, pills and granular preparations are the most commonplace pharmaceutical forms and it is indispensible that their main packaging be free of product contamination risks, while still guaranteeing line efficiency. We print single-/multi-layer, and aluminium films ranging from 20 to 250 microns, using rotogravure/flexographic technology for both small and large batches. Multiple curing options for both UV- and water-based inks, even for solvent-free solutions, extends the range of specific print finishes for each application.

Flexible

We print on lacquered aluminium foil in rolls with heat-sealantsfor PVC (Polyvinylchloride) / PVdC (Polyvinylidene chloride), PET (Polyethylene terephthalate) and PP (Polypropylene) plain and/or printed for the main packaging of pharmaceutical blister packs (20, 25, 30 micron thicknesses). A wide range of formats is available for 50 pills or gelatinous capsules, both for small and large batches. We guarantee technical examinations of the print work via automated production line inspection systems and chemical analyses at certified laboratories.

The sachets, which appeared first to meet the need to promote products or contain samples, have undergone rapid market growth. We print on a variety of combinations paper + aluminium; PET + aluminium;paper + PET + aluminium;for each lamination, ensuring the most suitable film for each application. We combine maximum reliability regarding product protection with a wide range of seals for maximum product integrity.

We print on full-body thermo-retractable shrink-wrapping film in order to enhance the appeal of the more irregular bottles as well as on tamper-proof seals with horizontal and vertical perforations. We support our clients with 3D software right from the pack prototyping phase to ensure optimal application during the shrink retraction phase.

The development of single-dose solutions and growing interest in on-the-go treatment administrations have been responsible for the success of this product, which favours portability of liquid, gelatinous and granular medicinal products without abandoning their barrier properties. Using 40% less material, they also represent a sustainable solution.

The need to facilitate ingestion of only the prescribed doses, is combined with a flexible and extremely versatile product.We print a wide range of high-print quality combinations for all personalised solutions, which combine excellent barrier properties with good mechanical characteristics.

aluminium forblister packs

shrink sleeves

sachets stick packs

strip packs

proceduresSpecific protocols and in-house test laboratories guide our technical staff in identifying the most suitable material for each application, for instance in finding the barrier solutions that are best for protecting against light, oxygen and all types of perfume. A new class 100,000 cleanroom will be dedicated to primary package production.

controlWe have cutting-edge technology to check there are no dead folds with material thanks to a tensioning systems during the conversion phase. Furthermore, cooling systems on the production lines ensure there is maximum fine adjustment precision even on the gripper edge, in order to reduce production waste, whilst production line inspection systems (Shark Lex 4000) ensure that print work compliance with master artwork is checked.

securityThe increasing complexity of print work is a barrier against the spread of counterfeiting. We have a multiplicity of printing units (up to 10, even including reverse printing) with combined print technologies for special finishes. We are able to print embossing, holograms and use special IR / taggant inks. We offer material personalisation services, even including the application of tamper evident solutions such as added safety labels, 3D films and void labels.

FlexiblePharma Mentis

More than simple packaging: made-to-measurecustomer care and customized services.For us, client satisfaction does not end with the delivery of a printed product that complies with the Technical Specification requirements. To build up a reliable long-lasting partnership with our clients, we have devised a customised service that is flexible, speedy and provides precise answers. We supply a made-to-measure service that is compatible with their needs.

We can provide a new design and prototype within 24 hours: for each promotional or clinical trial requirement, we design new packages using specialised 3D software, digital production lines and cutting plotters. Even for small quantities, our answer to you is always “Yes we can”.

Our integrated planning and digital order management functions enable us to guarantee personalised management models such as Vendor managed inventory (VMI) and Consignment Stock. Dedicated accounts enable us to promote unique data flows for each division, for all our products.

Services

24 hours support for new designs and prototypes:

Supply Chain:

Pharmaceutical bollino labelling:

Nucerialab:

Small lots and express delivery:

We apply optical pharmaceutical adhesive labels in segregated areas with final reconciliation reports, on structured production lines featuring intrinsic safety software. In addition, the same production line has print heads for handling variable data.

Our group’s creative drive comes from engineers who are specialised in developing solutions that are innovative because of their diligent collaboration with research institutions and supply chain partners. Above all, we achieve this by spending several training days with our clients to allow us to analyse new market trends together.

Targeted investments in Hp Indigo digital production lines and lean logic-inspired procedures ensure maximum management flexibility when handling even very small batches. We provide our clients with support so as to help them be positive towards the opportunities offered by the market and to react immediately to exceptional unplanned requirements.

Quality is seeingwhat others don’t see.

All our plant facilities implement a certified quality system. Likewise, all our resources have been set up on the basis of observing GMP regulations. We guarantee full traceability of our raw materials, which only come from approved suppliers. Thanks to our multi-plant structure, we have back-up systems in place, giving us a company policy compliant with the need for risk assessment. Our computer facilities are protected by stringent authentication systems and procedures inspired by Lean logic, which promotes waste reduction and the recovery of productive efficiency.

We are certified:ISO 9001:2008, ISO 22716:2007, BRC/IoP ver. 4, BRC/IoP ver. 4, ISO 14000:2004, OHSAS 18001:2007, FSC e PEFC.

Many treatments and one solution:

a partner who gives youthe chance

to devote yourselvesto your actual core business.

Always without side effects.

phone + 39 02 92853205info@nuceriagroup.comwww.nuceriagroup.com

facebook: nuceriagrouptwitter: @NuceriaGrouplinkedin: Nuceria Group

Noceravia Lamia - zona ind.le,84015 Nocera Superiore (Sa)

Salernovia Acquasanta, 84131 Salerno

Milanovia Benaco, 220098 San Giuliano Milanese

TorinoAppia Etichettevia Chieri, 89 10020 Andezeno (To)