Implementing serialization in your production line? | Omron, Europe

Login

Please use more than 6 characters. Forgot your password? Click here to reset.

Change password

We are experiencing technical difficulties. Your form submission has not been successful. Please accept our apologies and try again later. Details: [details]

Download

Register

We are experiencing technical difficulties. Your form submission has not been successful. Please accept our apologies and try again later. Details: [details]

Download

Thank you for registering

An email to complete your account has been sent to

Return to the website

get direct access

Fill in your details below and get direct access to content on this page

Text error notification

Text error notification

Checkbox error notification

We are experiencing technical difficulties. Your form submission has not been successful. Please accept our apologies and try again later. Details: [details]

Download

Thank you for your interest

You now have access to Implementing serialization in your production line?

A confirmation email has been sent to

Continue to page

Please or get direct access to download this document

Implementing serialization in your production line?

Take the next step in your serialization solution layout, implementation or upgrade. Contact us at any stage of your serialization implementation process - from concept studies and first pilots to complete stations in your lines. You can also benefit from our experiences with integration in new machines and upgrade cycles. Contact us today.

Contact us directly

Our Flexible Layer concept takes the approach to support the data exchange towards central repositories (e.g. EMVS, FDA-GUDID, ANVISA, etc.) and towards the supply chain (e.g. as required by DSCSA) through a central producer hub from the ERP/Master Data environment (Level 4). Special solutions may be realised for single site manufacturers.

Central repositories and supply chain (level 5)

Europe / EMVS

securPharm / ACS Pharmaprotect

The serialized data exchange in Europe under the umbrella of the European EMVS for pharmaceutical products can be realized e.g. for sales in Germany via the European hub (router) or directly to the national verification system upload structure. In both cases the data arrives at ACS PharmaProtect GmbH operating the national verification system upload structure in cooperation with securPharm e.V. For a marketing authorization holder (MAH) putting a pharmaceutical product into the German market, a contract with the ACS PharmaProtect GmbH is required.

Practically the two options to upload codes can be viewed as: 

  1. The multi-site/multi-national approach: here it may be recommended to manage the data exchange via a central IT hub in the ERP/Master Data environment (Level 4) and then upload via the European EMVS hub (router) interface.
  2. The single-site/national-only solution: in addition to the EMVS hub, a direct upload from the site level 3 may be realized (through an optional module of the Omron solution concept) and manage the data upload on national level via the ACS interface directly.

SecurPharm and ACS consider themselves a model and component of the European shield against the falsification of medicines. As an MAH placing prescription medicines on the market in more than one European country, you need to ensure that the associated pack data are stored in the databases of the respective national verification systems. To make the process of data provision to the national verification systems easier, the so-called European-Hub (short: EU-Hub) is supposed to work in the form of a router: At the centralized upload of the data files, they will be prefixed with a country code, which enables the EU-Hub to transmit the data to the correct national database. As a result only one interface and single upload are required. Of course, the established interface to the ACS MAH system will remain operational.

ACS provides two interface functions: Via portal (HTTPS), or via machine interface (SFTP). Moreover a wealth of reports can be accessed in the ACS Portal.

Find out more about securPharm Find out more about Pharmaprotect

ERP/Master Data environments (level 4)

Our FlexLayer concept supports the exchange with various suppliers of ERP / Master Data management solutions. Details are available on request.

Site and line solutions (levels 2 and 3)

Turn-key serialization stations (including level 1)

With the experience of millions of serialized packages in their own company, Prestige Promotion has made its proven line serialization station commercially available to other companies. This solution provides printing and inspection, and also manages the serialized code communication. Moreover, it does so with a very high degree of flexibility and can easily adapt to different master data handling and communication concepts as well as upcoming changes. It is tailored to the requirements of small- and mid-sized CMOs, CPOs, repackers and pharmaceutical manufacturers.

Located in Kleinostheim, Germany, in the heart of Europe, Prestige Promotion and Prestige Packaging offer a wide range of outsourcing, re-packing, distribution and service solutions to cosmetic and pharmaceutical companies.

With over 20 years of experience and approx. 250 employees, Prestige Promotion and Prestige Packaging support pharmaceutical and cosmetic companies in managing the various hurdles to market their products in the European Union. Flexibility, reliability and a drive for innovation are thereby the guiding principles for all operations.

Read also our Customer reference.

Find out more

Turn-key serialization stations (including level 1)

The ModuTrack Track & Trace solution is a ready-to-use compact and flexible marking and verification system for serialization and aggregation in pharmaceutical packaging lines.

The solution integrates into various MES/ERP systems and uses a horizontal and vertical REA JET printing solution for highest flexibility to adapt to different carton package sizes.

ETW Wollmershäuser GmbH, based in Wolpertshausen in the German state of Baden-Wuerttemberg, specializes in control technology, cabling and industrial electronics.

With 28 employees, the company implements new systems and system conversions in a range of industries — from the pharmaceuticals industry to air and space travel. The German company’s portfolio also includes its own products, such as engine controllers, camera housings and oscillating conveyor control devices.

Find out more

Turn-key serialization stations (including level 1)

The Masterprint PharmaJet series provides ready-to-use marking solutions for a wide range of pharmaceutical products including blisters, bottles, jars, vials, tubes and cardboard packages (flat (empty) and in erected (filled) state). Supporting GS1 compliant code serialisation, the PharmaJet series provides reliable and excellent value for money marking solutions for fulfilling the European Falsified Medicine Directive (other countries on request). Located in Ivancsa south of Budapest/ Hungary, Masterprint Kft has developed into a leading regional player for marking applications.

With sister companies providing machines and services for marking, printing, weighing, food cutting and secondary packaging, the Masterprint Group has become a trusted supplier to the Pharmaceutical, Food&Beverage and various other industries for Central and Eastern Europe.

Find out more

Turn-key serialization stations (including level 1)

The Transvis-CTI  STE300 serialisation and tamper evident labelling station provides a compact and ergonomic solution for FMD-compliant carton labelling and coding for up to 300 products / minute. The ready-to-use machines are equipped with slide-out Blum-Weber marking and labelling modules, Omron automation equipment and an open IT architecture structure that allows easy integration of serialisation softwares, line and site server solutions. The stations can optionally be combined with checkweighing modules, labelling modules, or others.

Located near Orléans in the heart of France, Transvis-CTI has 30 years of experience in providing new and retrofitted machines for filling, labelling, marking, packaging, inspection and handling to the pharmaceutical, food&beverage, cosmetics, tobacco, automotive, and various other industries.

Find out more

Serialization / Track&Trace Software

Facilityboss is located in southern Germany in Darmstadt. Founded as spin-off from the Fraunhofer Institut SIT, Facilityboss focuses on class-leading IT solutions, providing high customer satisfaction.

Facilityboss develops various standardized products, which can be customized to specific needs. The Facilityboss PLS track and trace (GS1 serialization) system, e.g. for the pharmaceutical industry, is already in use in various sites of leading DAX-listed pharmaceutical producers as well as smaller sized CMO/CPO sites.

Also for food & beverage applications the software is already in use for leading producers.

Find out more

Serialization / Track&Trace Software

Located in Paris in France, Adents works with leading pharmaceutical companies in North America and Europe to provide product unit identification and traceability software solutions. With over 150 lines running Adents software, the PharmaPilot, PharmaSupervisor and PharmaExchange modules connect with the automation layer to provide serialization, aggregation, event exchange and integration to MES/ERP layers.

The standard software platform is designed to quickly interface with IT environments, easily interoperate with hardware devices and offer a high level of flexibility to users.

Find out more

Printing solutions (level 1)

Founded in 1978 and headquartered in Cambridge, UK, Domino has a global reputation for the development and manufacture of coding, marking and printing technologies that satisfy the requirements of manufacturers and commercial printers.

Domino’s year-on-year growth – both organic and through acquisition – is underpinned by an unrivalled commitment to product development, resulting in a portfolio that incorporates complete end-to-end coding solutions spanning primary, secondary and tertiary applications.

Innovative ink jet, laser, print & apply and thermal transfer overprinting technologies are deployed for the application of variable data, bar codes and unique traceability codes onto product and packaging, across many industrial sectors, including pharmaceutical, food, beverage and industrial products.

Find out more

Printing solutions (level 1)

REA JET develops and manufactures premium industrial coding and marking systems for contact-free industrial marking. The portfolio includes ink jet printers, laser and spray mark systems, labeling solutions, as well as inks and consumables. The practically orientated products are designed for use in all branches and are proven worldwide across all industries and business segments. REA JET and REA VERIFIER (Code Verification Systems) are both divisions of REA Elektronik GmbH based in Muehltal, near Frankfurt am Main. REA Card, another REA division, develops and markets cashless payment systems.

REA Elektronik was founded in 1982, it is owner-operated and employees 300 staff (2014). All REA JET products are 100 percent made in Germany.

Find out more

Overall serialization / traceability consulting and compliance support

Vesdo Inc., a Swiss engineering and consulting firm, active since 2000 has its business focus on systems to fight product piracy. To prevent frauds with branded products, Vesdo’s customers successfully implement authentication technologies and product serialization. As a leading company in this industry, Vesdo has been a pioneer and involved in more than 100 implementation projects throughout Europe, serving small entities as well as global tier 1 companies. Over 20 patent applications for customers and Vesdo provide evidence of the company’s creativity. Core to the company is the highly qualified staff, all with university degree and comprehensive experience.

Vesdo Inc. has also developed a calibration reference for vision systems used in connection with code grading applications. These sets of compliance codes in the form of self-adhesive labels can be used to calibrate also in-line vision systems.

Find out more

Overall serialization / traceability consulting and compliance support

Omron is an active member of the Open Serialization Communication Standard (Open SCS)  working group. Driven by Healthcare Providers, the Open-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade.

The Open SCS Working Group (Open-SCS) is partnered with the OPC Foundation to develop an open source standard in the Packaging Serialization Global Name Registry.

Find out more