MEDICAL& HOSPITAL AUTOMATION

Medical robotics and automation

TABLE OF CONTENTS

THE COMPANY IN FIGURES

HOW WE WORK

MEDICAL AUTOMATION

• The importance of validation in the medical field

• Operations and functions of our automated systems

• Products from our automated systems

• Products for intravenous infusion

• Products for intensive care

• Products for cosmetics

• Products for medical labs

HOSPITAL AUTOMATION

• Hospital service: from analysis to assistance

• Presentation of Athena

• Our solutions

THE EVOLUTION OF SINTECO• Quality and certifications

CONTACTS

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THE COMPANY IN FIGURES Sinteco SpA,established in 1984,is a leader designer and manufacturer of robot-controlled systems, automatic lines and machines for industrial production with more than 1,900 assembling lines around the world.The projects designed by the company combine state-of-the art technologies, efficiency, flexibility, reliability and top quality, thus being able to meet the client’s specific needs.

HOW WE WORK Sinteco handles the entire

production process, from the design to the manufacturing and assembly of the systems.

High qualified project managers ensure accuracy and precision in the production process.

A ten years’ experience in the medical field is combined with the use of the most advanced testing protocols.

Analysis and understanding of the client’s requirements.

Flexibility in adapting the systems to the market requirements and in promptly meeting the client’s needs in terms of project changes.

Control and reduction of waste during the design, development and manufacturing of the products, with an eye for recycling.

Clients’ requests are promptly addressed and products are delivered on the agreed-upon delivery date.

A thorough functional testing ensures high quality standards and adherence to safety and quality regulations.

Specialized after-sales service to solve promptly any product-related issue.

Experience

Analysis

Flexibility

Assistance

Guarantee

Punctuality

Sustainability

Planning

Precision

10.000 m2manufacturing space10.000 m2manufacturing space

17mechanical design engineers 5

electrical engineers

13control and software design engineers

50assembly technicians

4 facilities

6project manager

5after salesassistants

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MEDICAL AUTOMATIONMedical robotics and automation

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1. Cutting, punching and pressing

2. Dosing and filling

3. Feeder technology

4. Hot sealing

5. Labelling

6. Marking and molding

7. Packaging

8. Paper banding

9. Tracking

10. Screwing

11. Testing and inspection

12. Tip forming13. Plastic tube coiling

14. Separation systems 15. Welding

OPERATIONS AND FUNCTIONS OF OUR

AUTOMATED SYSTEMSThe automated systems designed and developed for the medical field can create finished products combining in a single production process different operations.

The main functions designed and developed to create a high-quality medical product include:

The project undergoes a thorough testing,which includes:

1. Validation Package

2. Performance of FAT, SAT/IQ/OQ protocols

3. Training on the general principles of validation

Every system produced by Sinteco comes with the following documents:

1. Validation Plan

2. Functional Specifications (Hardware and Software)

3. Design Specifications (HD and Software)

4. Risk Analysis Report

5. FAT Protocol

6. SAT Protocol

7. URS-FS-DS-Testing and Traceability Matrix

8. Installation Qualification Protocol (integration of the FAT/SAT testing)

9. Operational Qualification Protocol (integration of the FAT/SAT testing)

THE IMPORTANCEOF VALIDATION IN THE

MEDICAL FIELDThanks to the experience developed working in the design and manufacturing of automated systems for different industry sectors, Sinteco can satisfy with competence all the requirements of the medical field, where projects must be tested and validated in each stage of the assembly process to ensure they meet the required standards.

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INDEXING DIALSReliability and precision combined with the most innovative solutions.

ROBOTIC CELLSPerformances, precision and dynamism integrated with the most advanced and customized vision systems.

TRADITIONAL CONVEYORS WITH PALLET RICIRCULATIONFlexibility on both big and small processes in closed cooperation with the customer throughout the entire complex cycle of the project development.

INDEXING CHASSISGreat loading capacity, precision and versatility.

STANDARD CELLSThe perfect synthesis between experience and dynamism for a fast and personalized solution.

TYPES OF AUTOMATED SYSTEMS TYPES OF AUTOMATED SYSTEMS

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PRODUCTS FROM OUR AUTOMATED SYSTEMS

PRODUCTS FOR I N T R AV E N O U S INFUSIONProducts for intravenous infusion of liquids and transfusion devices.

PRODUCTSFOR COSMETICS

Products for carrying and dosing cosmetics and creams.

PRODUCTS FOR INTENSIVE CARE

Respiratory products forbreathing support.

PRODUCTS FORMEDICAL LABS

Products for medical laboratoriesand test results storage.

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PRODUCTS FORINTRAVENOUS INFUSION

PRODUCTS FORINTRAVENOUS INFUSION

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Accuracy and precision in the assembly of the product.

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PRODUCTS FOR INTENSIVE CARE PRODUCTS FOR INTENSIVE CARE

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Strict testing and validation systems.

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PRODUCTS FOR COSMETICS PRODUCTS FOR COSMETICS

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Care for detailsduring the production process.

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PRODUCTS FOR MEDICAL LABS PRODUCTS FOR MEDICAL LABS

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Respect of technical requirementsand qualitystandards.

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HOSPITAL AUTOMATIONMedical robotics and automation

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Consumption analysis

Spaces analysis

Human resources analysis

Logistics analysis

Offer

Contracts

Programming

Tailored solutions

Analysis of the client’s medicines consumption

Analysis of available spaces and of the client’s facility (single unit, pavilions,

on regional basis…)

Analysis of human resources (opening days and hours of the hospital pharmacy)

Analysis of the logistics of the hospital (pneumatic mail, AGVs,

logistics operators)

Development of a tailoredsolution designed to meet thespecific needs of the client

Study of a gradual implementationaccording to the client’s capabilities

Proposal of post-sales contracts (warranty extension, tele-assistance, software updates, full risk, technician for the on-site management of the automated system)

Training offer (on-site training sessions for users and end users)

HOSPITAL SERVICE:FROM ANALYSIS TO

ASSISTANCEIn 2002 Sinteco created the HOSPITAL AUTOMATION division, specialized in the research and development of new technologies for hospitals. The focus is on quality, risk management and automation of the process.

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ATHENA MAIN FEATURES• flexibility and adaptability to hospitals and retirement homes of different sizes

• medicines tracking and integration with the client’s computerized systems

• the processes of prescription and distribution of medicines are free of human errors

• optimization of storage and substantial reduction of pharmaceutical costs

• possibility to distribute medicines even in case of system failure

• distribution of unit doses of medicines

PROMPT

ATHENA SYSTEM

RELIABLE

MODULAR

QUICK TO INSTALL

MANAGEMENT OF COMPLEX

FACILITIES

REAL-TIME COMPUTERIZED PRESCRIPTIONS

PRESENTATION OF ATHENAThe product presented by the HOSPITAL AUTOMATION division of Sinteco is Athena: a flexible and modular system for the management of unit doses of medicines. This system allows for the grouping and identification with patient name of the medicines prescribed to each patient, and subsequently for the distribution of personalized unit doses.The Athena system was developed to answer the real needs of a hospital. It is not just a serial system (packaging-storage-delivery), but a network of automations where each unit is connected to the other allowing for significant advantages in terms of convenience, quality and cost saving.

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CENTRALIZEDAll the operations are conducted in the pharmacy: cutting, packaging, storage and preparation of personalized therapy.

OUR SOLUTIONS

ULISSEDepartment returns management machine.

ATTISAutomatic medicine blister cutting system.

HERMESPrescriptionstransportation machine.

HYDRAComputerized Athena system cabinet for the storage of unit dose packets.

PEGASUSComputerized Athena system cabinet for the storage of unit dose packets.

CALYPSOCutting and packaging machine.

HEMERAMachine for the preparation of personalized therapies.

DECENTRALIZED(OR CLOSE TO THE PATIENT)In the pharmacy only the doses are prepared (cutting and packaging). The doses are then regularly (two or three times a week) delivered to the departments. In the departments a robot receives and stores the doses, and prepares the personalized prescription.

MIXEDWith this solution part of the prescriptions are prepared in the pharmacy and part are personalized in the department. The choice is made according to the consistency of prescriptions.

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QUALITY AND CERTIFICATIONS

The competence and specialization of Sinteco in robotics and automation for the medical field comes from quality standards which meet the requirements of international testing and certification protocols.

Working together with clients during the validation and certification processes allowed Sinteco to create automated systems for extremely complex biomedical products.

CFR ISO 1348521 CFR PART 820 GHTF PROCESS VALIDATION GUIDANCE GAMP5

BUCCI INDUSTRIESHeadquarters Via Mengolina 2248018 Faenza (RA) - ItaliaTel. +39 0546 698100 Fax +39 0546 46598

BUCCI INDUSTRIES FRANCEIemca France 145 Rue Louis Armand Z.I. des Grands Pres F - 74300 ClusesTel. +33 450 896960 Fax +33 450 896135 Email: iemca@iemca.fr

BUCCI INDUSTRIES GERMANYBucci Industries Deutschland GmbHStammheimer Str. 10D-70806 KornwestheimTel +49 (0)7154 83 70 70-0Fax +49 (0)7154 83 70 70-25E-mail: info@bucci-industries.de

BUCCI INDUSTRIES TAIWANGIMCO Giuliani Iemca MachineryNo. 301-1, Dongsing Rd.,Dali City, Taichung County, 412,408 Taichung, Taiwan R.O.C.Tel. +886-4-2406-6970Fax +886-4-2406-6943Email: gimco@gimco.com.twwww.gimco.com.tw

BUCCI INDUSTRIES USAIGM USA Inc . 9332 Forsy th Park Drive Charlotte NC 28273 – USA Phone +1 704 583 8341 Fax +1 704 583 8486 Email: info@bucci-industries.uswww.iemca.us

BUCCI INDUSTRIES JAPANIGM Nippon K.K. - Shimizu Bldg 1F,31-15 Nakakasai, - Edogawa-Ku, Tokyo,134-0083 JapanTel. +81-3-5605-8016 - Fax +81-3-5605-8066Email: h.murakami@igmnippon.co.jp

BUCCI INDUSTRIES CHINABi-tech (Suzhou) Co.Ltd.Wu Fang Road, Wu Jiang City,JiangSu Province- PRCTel. +86 512 8155 6988 - Fax +86 512 8155 6986Email: bi-tech@bi-tech.cn

BUCCI INDUSTRIES BRASIL Bucci Industries Brasil (IGM do Brasil LTDA)Avenida dos Pinheiros 465 13280-000 - Vinhedo SP (São Paulo) BrasilTel. +55 19 3515 7220Email: contato@buccibrasil.com.brwww.buccibrasil.com.br

SINTECOZona Industriale Villanova32013 Longarone - ItaliaTel. +39 0437 772146 - Fax +39 0437 573411Email:sinteco@sintecorobotics.comwww.sintecorobotics.com

THE EVOLUTION OF SINTECO

1984: Sinteco is founded. In only a few years it becomes a leader company in the automation industry worldwide.

1998: a second facility is established, S inteco2, specia l ized in the manufacturing of personalized and design-based mechanical units.

2002: the third facility, Sinteco3, is established, and in the Sinteco group enters Vibrosystem s.r.l., designer and manufacturer of high performance circular and linear vibratory feeders.

2002: creation of a new business-unit, Hospital Automation, dedicated to the design and development of automated systems for the medical field.

2003: the company becomes a member of Bucci Industries, which has been on the international market for over 40 years with the leader companies Iemca, Giuliani, Vire and Riba Composites.

2008: acquisition of TecnosinT s.r.l., an extremely competitive and flexible company designing and developing small-medium sized assembly and testing systems.

Nowadays: 4 facilities on 10,000 square meters, 150 employees and over 1,900 Sinteco automated assembly lines around the world.

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SINTECOZona Industriale Villanova32013 Longarone - ItaliaTel. +39 0437 772146Fax +39 0437 573411Email:sinteco@sintecorobotics.comwww.sintecorobotics.com