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serializationand tamperevident solution

POWERED BY

Systech and Elmed

Experienced manufacturers working together to bring serialization ready packaging machines to the market. The machines are serialization ready with all interfaces and workflows defined and tested.

Systech and Elmed deliver serialization-ready equipment preconfigured with Systech’s industry leading serialization software.

The Elmed S-Series is specifically designed for pharmaceutical serialization, provides in-line printing, tamper evident labelling and verification for serialization in a robust and compact design.

This model is equipped with either a Domino D320i laser or Domino G320i OEM printer, a reject station and Systech vision system for product inspection.

The system highlights the seamless integration of Elmed equipment with Systech’s data management software.

Benefits

Highest Value Solutions Faster Line Deployment Fail-safe Programming Robust Design Reject Verification

About ELMED

ELMED company specializes in providing integrated solutions and latest technologies in the field of marking, labelling, packaging and inspection of products.

Our years of experience in this field and cooperation with world-renowned brands, ensures our knowledge and skills for providing solutions for coding, inspection and labelling requirements in the pharmaceutical industry is second to none.

ELMED engineering

Our team of design engineers has expertese comprising of mechanical and electrical designing, manufacturing, PLC and PC programming and mechatronics:

Mechanical design is made in Autodesk Inventor Electrical design is made in Eplan PLC software programming is made in

Siemens Totally Integrated Automation Portal Software in the PC environment is made in:

Visual Studio C#, C++, .NET, Microsoft SQL Server

Print, verify andtamper evident

seal unit

ELMED is focused on delivering robust systems, designed for long lasting usage in production environments. For all our products mechanical designers use stainless steel and aluminium and follow GMP guidelines for all enclosures, brackets and ejectors. Our goal is to design and produce rugged solutions that are well engineered, easy to integrate and user friendly.

Validation specialist

With over 15 years of ongoing collaboration with pharmaceutical customers, we understand the importance of documentation. Our experienced Validation Specialists are from the pharmaceutical industry and our certified Technical Writers ensure that your operation manual is adapted to your specific solution.

Validation documentation, as part of our standard documentation, is prepared for individual customer needs and contain all the required elements: qualification plan (QP), design and function design specification (DS &FDS), hardware and software design specification (HDS & SDS), installation qualification (IQ) - protocols, tests and procedures, operation qualification (OQ) - protocols, tests and procedures and performance qualification (PQ). We also provide assistance in factory & site acceptance testing - protocols, tests and procedures, functional risk assessment and performance qualification - protocols, tests and procedures.

Quality control

Our experts in the Quality Control Department use both generic and specific test plans to test the entire solution. The Quality Control Technician performs a pre-validation of the system prior to shipping, ensuring that the integration process will go smoothly and will be completed in a timely manner.

Under ISO9001:2008 our management ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.

Serialization and tamper evident solution

In cooperation with our partners from SYSTECH we can provide a complete Serialisation and Tamper evident solutions, tailored according to customers’ demand.Width range of options from basic print & verify functions up to tamper evident and vignette labelling, with variety of additional modules, guarantees that we can satisfy even the most demanding serialization requirements with rugged design and sophisticated software solution.

Intelligent rejectsystem for printing

and labeling

Main features:

Robust design User-friendly operation Flexible integration into existing lines Suitable for printing on front and

back (simultaneously if required) Precision guiding of folding boxes

for high-quality printing Modular and expandable Built-in two-sided labeller for TE labeling (option) Built-in top labeller for vignete labeling (option) Toolless changeover Fully automatic product changeover (option)

Design improvements

In our quest for innovation and additional quality for our customers, we developed a fully automatic product changeover function. This enables operators automatically to setup sizes of diferent products through simple recipe selection using stepper motor drives.

ELMED labels

In addition to its business ELMED has a production of self-adhesive label and can provide you tamper evident labels from materials of the world’s leading self-adhesive paper manufacturers.

About Systech

Systech is the global technology leader in anti-counterfeiting, product safety, consumer and brand protection. Systech pioneered serialization and is defining the future of authentication.

Systech unifies and optimizes authentication, enterprise serialization and track-and-trace technologies to ensure regulatory compliance, mitigate risk, and drive efficiency and profitability.

For more than 30 years, our innovations have led best practices for key brands representing companies within the pharmaceutical, consumer packaged goods (CPG), food and beverage, aviation, automotive, and life sciences industries. Systech works globally with 19 of the top 20 pharmaceutical companies.

UniSeries

The Systech UniSeries™ suite is a cross-level, robust enterprise platform. From manufacturing to retail, UniSeries serializes and tracks and traces your products throughout the supply chain. This enables you to meet regulatory compliance requirements and have the information you need for your products regardless of where you may be located globally.

Systech’s UniSeries platform offers end-to-end serialization solutions to meet your needs

Level 4 | Enterprise Enterprise serial number range management

Validates serial numbers and packaging hierarchy

Meets today’s and future regulatory compliance

Can be upgraded and re-configured to any line

Integrates with existing or new equipment

Level 3 | Site

Level 2 | Line

Level 1 | Device

Innovation

UniSeries

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Implementation

Typical serialization programs present significant risks to manufactures’ operations during and post implementation. Systech’s proven implementation methodology and established serialization solution are designed to minimize downtime on your line or lines and safeguard operational stability.

As you consider your serialization options, many companies employ solutions in response to a current need or regulation. However, one must consider whether the chosen solution will go beyond the current state and protect their investment for the future. Systech’s solution provides the answer.

Safeguarding Your Present and Future

Systech’s UniSeries delivers a productized, configurable and expandable serialization solution that grows with you and your business requirements. UniSeries addresses current regulatory requirements – both locally and globally.

It is set-up to adapt and change for future state regulations. This allows you to be better positioned to deploy serialization in other locations and take advantage of future opportunities.

Efficient Deployment Methodology & TCO

Systech promotes rapid and consistent deployments by productizing solution standard standards across common packaging use cases, reducing implementation, training and support costs. By continuously analyzing client needs, we refine our implementation and support, ultimately incorporating enhancements and efficiency gains throughout the project.

Our unique approach includes rigorous and detailed initial data gathering, solution design, in-house configuration and testing prior to field installation.

Community & Support

Within decades of industry leadership, Systech has met the needs of its clients by providing state of the art training and support for our customers.

Our training programs run year-round and are provided in Europe, the US and for many classes on-site at your location.

Systech’s Customer Care team offers customers a variety of ways to get the best customer support possible.

ELMED d.o.o.JNA 166, 21235 Temerin, Serbia

T: +381 (0) 21 844 767F: +381 (0) 21 844 787

FMDsolutions@elmedint.comwww.elmedint.com

ELMED company operates in accordance with ISO9001 standard

Technical specification

Series S/P Series S/PT Series S/PTVOperational capability:

Machine efficiency up to 400 pcs / min up to 400 pcs / min up to 400 pcs / min

Belt speed up to 50 m/min up to 50 m/min up to 50 m/min

Min carton size 35 x 15x 60 mm (WxHxL) 35 x 15x 60 mm (WxHxL) 35 x 15x 60 mm (WxHxL)

Max carton size 120 x 100 x 200 mm (WxHxL) 120 x 100 x 200 mm (WxHxL) 120 x 100 x 200 mm (WxHxL)

Conveying system upper and lower belt upper and lower belt upper and lower belt

Machine direction left to right

(other options available)

left to right

(other options available)

left to right

(other options available)

Coding System:

Printing technology TIJ (standard), laser (option) TIJ (standard), laser (option) TIJ (standard), laser (option)

Number of print heads: up to 4 (4 x 12.7mm) up to 4 (4 x 12.7mm) up to 4 (4 x 12.7mm)

Print position front and/or back print position front and/or back print position front and/or back print position

Camera System:

Field of View46mm (H) x 62mm (W)

(other options available)

46mm (H) x 62mm (W)

(other options available)

46mm (H) x 62mm (W)

(other options available)

Data Matrix Minimum element size 0.25mm Minimum element size 0.25mm Minimum element size 0.25mm

Bar Codes Minimum bar width 0.15mm Minimum bar width 0.15mm Minimum bar width 0.15mm

Labelling system:

TE labellers - Herma H400 Vario M Herma H400 Vario M

Vignette labeller - - Herma H400 Vario M

Options:

Options and modules different options and modules different options and modules different options and modules

Automatic size changeover Option Option Option

Cabinet & requirements:

Frame structure Stainless steel / aluminium Stainless steel / aluminium Stainless steel / aluminium

Dimensions 1.140 x 2160 x 975 mm (WxHxL) 1.200 x 2.160 x 2.045 mm (WxHxL) 1.200 x 2.160 x 2.395 mm (WxHxL)

Weight approx. 180 kg approx. 650 kg approx. 740 kg

Air pressure 6 bar 6 bar 6 bar

Electrical requirement 220V, 50 / 60 Hz, 10A 220V, 50 / 60 Hz, 10A 220V, 50 / 60 Hz, 10A