PHARMA TECHNOLOGY THAT MAKES THE DIFFERENCE- Fedegari Group

Industry 4.0:  a technology-centered company with a prestigious position on international markets thanks to the know-how acquired through the development of automation technology in-house

By Nicoletta Buora, Notiziario Chimico Farmaceutico (NCF), June 2017

 

 FEDEGARI_TECHNICAL_TRAINING

Fedegari‘s adventure begins over 60 years ago in Pavia with the handicraft production of carpentry artifacts. Today, the company, led by the second generation, is a hi-tech company that exports bio-pharmaceutical sterilization machines and plants worldwide with products ranging from small machines for Laboratory to fully automated and high-throughput plants. Italian excellence stories are very similar in the path, but each has its own distinctive element. That of Fedegari is having a “technological heart”, given the total control of technology and represented by its own Thema4 processor. This has generated profound knowledge of machines and processes allowing the company to reach the cutting edge in innovation. “The important step,” explains the president Giuseppe Fedegari, “took place around the year 2000 when we decided to replace old custom processors based on custom hardware with a new generation of process controllers installed on our machines.” At the same time, the company created an automation division and invested in VxWorks, a very reliable real-time operating system to develop everything in-house, from components to systems.

From Pharma to Food

Today, Fedegari is a Group with a consolidated turnover of about 65 million Euros (2016) and around 450 employees distributed between Pavia and Switzerland – where the production units are located, other branches in Munich – Germany, Singapore and the Tech Center of Philadelphia. “The United States is the most important pharmaceutical industry,” continues Giuseppe Fedegari, “so we have opened a Technology Center where American customers can see their machines running. This way they can work on process and train development. The US Tech Center has become a place to share experiences that have changed our business prospects. This year, the FDA(Food & Drug Administration) has asked us to repeat some training courses for its inspectors: an important experience that we can transfer as a value to our customers. “The same format will be replicated shortly in Singapore.  Asia is the other big expanding market for Pharma. The Tech Center in Singapore will offer opportunities to exchange experiences with the customers of the newly opened branch in China. Fedegari’s other business area is food processing, where high levels of efficiency are required for strong market competitiveness and reduced margins. “In the last few years we have been working on the sterilization process of tuna cans and it has been an enlightening experience,” said Giuseppe Fedegari. The customer – a large multinational – chose our machines despite the higher cost compared to other sterilizers dedicated to the food industry. The superior performance achieved with Fedegari process equipment has allowed them to drastically reduce production costs.”

When the vision is farsighted

Manufacturers create value for the customer offering something that goes beyond the functionality required in the form of new services. “We started working hard to make machines and processes more efficient – continues Giuseppe Fedegari – to provide customer benefits and differentiate our offerings from competitors, but also because machines and systems have become much more complex and companies are investing less and less in training “. To follow this “philosophy”, a change of mentality was needed at all levels of the company, starting with the way in which we build the factory, with the latest generation technology. Fedegari is focused on different applications such as Cloud, essential to understand how customers use machines and to receive feedback information, IoT, to have more sensors able to capture possible variations in system functionality, Augmented Reality, for Maintenance, because it also allows a less experienced maintenance workers to solve problems rather than wait for the supplier to arrive. “Today, all this technology became Industry 4.0, but we have started applying it when there was not a concrete definition. We have started developing this approach several years ago simply because this is the only way to increase the efficiency of our machines. Our system already born “4.0” because it was projected onto the customer and the central point of the “4.0” is the active involvement of the customer, “concludes Giuseppe Fedegari.

 

 

Industry 4.0: Fedegari Predictive Maintenance System

Industry 4.0: Fedegari Predictive Maintenance System

Industry 4.0 on the field

“Our challenge in the Industry 4.0 moves on two fronts,” says Riccardo Boatti, Global Quality Assurance Manager.  The first front deals with the difficulty of producing customized orders over standard manufacturing. The other one regards the product itself, its use by our customer and how much he understands its technological content. Talking about the product, an emblematic example aligned with the concepts of “4.0” is the system developed internally for the predictive maintenance of the machines. We have been designing more and more intelligent machines, capable of interacting with external systems via Cloud platforms and diagnosing anomalies and critical conditions before compromising machine reliability. We have developed a system that monitors the use of individual plant components and consequently scales the residual useful life. In addition, this system allows to remotely control the status of any machine installed in the world almost in real time. Fedegari systems analyze the data and, based on appropriate algorithms, give an incremental wear that takes into account real working conditions (usage times, fluid temperatures, etc.).

The benefits for the user are twofold: on one hand, he is assured on the state of the machine as Fedegari technicians can analyze it remotely. On the other hand, the customer gets better maintenance management focusing only on components that actually require intervention, which also guarantees significant economic advantage. In the productive field, Fedegari is investing in several internal business areas: from PLM, Paperless, to the use of industrial tablets for various activities. Fedegari production departments have implemented tracing of material flows through RFID systems, QR Code, integrated management of production and machines, the use of highly automated equipment. To cite an example, we have recently purchased two state-of-the-art milling machines with telemedicine systems, adaptive control and ready interconnection with corporate IT systems. Sensor equipment allows continuous monitoring of working conditions and process parameters, providing real-time adaptation of the machine to any drift due to thermal and geometric variations.

Technology & Control

Thema4 is the process controller installed on all Fedegari machines. It was developed from the beginning to meet the strictest requirements of the pharmaceutical industry and is able to natively integrate with the existing SCADA and MES systems. “Thema4 is the heart of Fedegari and encloses the company’s technological history – says Boatti. The WindRiver VxWorks on-board operating system puts us in the position to develop the software that we then upload on the hardware. “Each machine is equipped with two computers, a Graphic Panel PC used by the operator to interact with the system and a Box PC, located inside the power cabinet, running the software that manages the sterilization process. “B&R is our hardware supplier, except in some markets where local suppliers are required,” says Boatti. The choice of the Austrian multinational (now acquired by ABB) is due to the company’s flexibility. It is a key requirement for Fedegari, since our core business is based on the customization of machines and systems.

OSHA Respirable Crystalline Silica Rule- Mesa Labs

The new OSHA Respirable Crystalline Silica Rule was published in March of 2016. All industries have responded which raised various questions regarding the new rule. Industry leaders want to know how they will be affected and why the new rule was written.

 

Mesa Labs wants to simplify the compliance process for its customers and thus has defined main points of the rule in an easy-to-follow manner.

  • Respirable Crystalline Silica is one of the most abundant materials in the Earth’s crust. It exists in three distinct forms: quartz, cristobalite, and tridymite. It occurs in the workplace when workers cut, grind, drill, saw, crush or process materials such as rock, sand, glass, stone, or brick. It can also be a byproduct of sandblasting, and hydraulic fracturing.
  • This rule is necessary because robust evidence indicates that current exposure limits do not protect workers’ health. Also, OSHA believes the new standards will prevent 642 deaths per year, which is projected to save employers $7.6 billion per year, based on the reduced mortality rates.
  • The new rule differs in three primary ways:
    • The new Permissible Exposure Limit (PEL) is 50µg/m3 per eight-hour Time Weighted Average (TWA) and employers must measure worker exposure if levels reach or exceed 25 µg/m3 as an eight-hour TWA.
    • Employers will implement techniques to greatly reduce workers’ exposure, such as wetting down or vacuuming dust to prevent workers from breathing it in.
    • Employers are also required to identify high-exposure areas and limit access to those areas. They are also required to offer respiratory protection plans, and possibly medical exams.

The new rule is set to a timeline, determined by OSHA.

  • June 23, 2017 – the construction industry must comply
  • June 23, 2018 – general and maritime industries must comply
  • June 23, 2018 – the hydraulic fracturing industry must comply

 

Source: http://mesalabs.com/2017/07/05/osha-respirable-crystalline-silica-rule/

Fedegari Full Automation Training

Greetings!

Our Representative will be attending the Fedegari Full Automation Training Week in Italy from June 26 till June 30. It’s an agents only course, but with our help you can get an inside view of the whole course

If you find anything you want to discuss with our rep on the seminar schedule, do not hesitate to reach out and get in touch.

Here is the schedule and the content that will get covered over the training session:

Moist heat sterilization general principles ​ (M. Ruggeri, classroom)

  • Sterilization principles (sterilization kinetics, meaning of D, z, F​0​, PNSU)
  • Sterilization methods
  • Moist heat sterilization
  • Saturated steam, Pressure-Temperature relationship
  • Evaporation and condensation
  • Importance of air removal
  • Fedegari saturated steam sterilization cycle

 

Autoclaves types and related loads​ (M. Ruggeri, classroom)

  • Saturated steam autoclaves (FOF)
  • Superheated water autoclaves (FOW)
  • Steam-air mixture autoclaves (FOA)
  • Different loads: how to choose the right autoclave?

Practical session at the machine

 

Fedegari decontamination systems​ (M.L. Bernuzzi)

  • Introduction to vaporized H​2​O​2 ​processes
  • Comparison of different processes and equipments
  • Decontamination technologies on the market
  • Overview of Fedegari systems (FCDV, FCDM)
  • General description
  • Technical documentation (ex. P&ID analysis)
  • Process documentation

Fedegari sterility test cabinets (FCTS) ​(M.L. Bernuzzi)

  • Equipment description and use

 

Fedegari washer machines (FSW, FOWS, FGW) ​(S. Ferretti)

  • General description
  • Machine description using technical documentation
  • Cycle execution
  • Washing application

Fedegari washer projects ​(L. Del Rio)

Spimaco Case Study ​(S. Mauri, H. Carbone)

Handling solutions from a commercial POV ​(H. Carbone)

Handling solutions from a technical POV ​(F. Fusi, G. Zappa)

Visit at BBraun system ​(F. Fusi, G. Zappa)

Thema4 overview ​(R. Di Benedetto)

Commercial discussion

 

Our rep will have unlimited internet access as well as international calls so do not hesitate to get in touch.

MaryBeth Eyer can be reached over email: marybeth@lsi1.com or phone +12178258110

Mesa Labs Provides Validation Services to DataTrace® Customers

May 16, 2017, (Lakewood, CO) – Mesa Labs’ DataTrace® data loggers are capable of withstanding harsh environments and have proven to be the premier line of data loggers in the field. As one customer claimed in a recent article, the new hermetically sealed DataTrace® sensors are designed for continuous monitoring under even the most adverse conditions. The fact that these sensors are hermetically sealed eliminates the problem of chemical attack which may cause problems with both thermocouples and the humidity sensors used. The new devices also provide increased protection against explosive hazards because they are designed based on the concept of intrinsic safety so that, even if the seal is penetrated, neither the device’s electrical or thermal energy is sufficient to ignite the gas vapors in a hazardous location.1

Mesa Labs not only produces superb data loggers, we also have the expertise and knowledge to provide Validation Services to our customers. We boast a nationwide service team that can be on-site in a timely manner and a dedicated Compliance and Validation Services Expert that can provide IQ/OQ/PQ services and documentation, warehouse mapping, equipment qualification and calibration, process control validation, consulting and assessment, and SOP development.

Few companies today have such comprehensive experience and knowledge of critical monitoring processes and how to make them meet operating regulatory guidelines. With Mesa, you’ve got a trusted partner with three decades of experience supporting you!

1 Source: https://www.pharmaceuticalonline.com/doc/validating-ethylene-oxide-eto-sterilization-0003

 

About Mesa Laboratories, Inc.

We pursue a strategy of focusing primarily on quality control products and services, which are sold into niche markets that are driven by regulatory requirements. We prefer markets that have limited competition where we can establish a commanding presence and achieve high gross margins. We are organized into four divisions across eight physical locations. Our Instruments Division designs, manufactures and markets quality control instruments and disposable products utilized in connection with the healthcare, pharmaceutical, food and beverage, medical device, industrial hygiene, environmental air sampling and semiconductor industries. Our Biological Indicators Division provides testing services, along with the manufacturing and marketing of biological indicators and distribution of chemical indicators used to assess the effectiveness of sterilization processes, including steam, hydrogen peroxide, ethylene oxide and radiation, in the hospital, dental, medical device and pharmaceutical industries. Our Cold Chain Monitoring Division designs, develops and markets systems which are used to monitor various environmental parameters such as temperature, humidity and differential pressure to ensure that critical storage and processing conditions are maintained in hospitals, pharmaceutical and medical device manufacturers, blood banks, pharmacies and a number of other laboratory and industrial environments. Our Cold Chain Monitoring Division also provides parameter (primarily temperature) monitoring of products during transport in a cold chain and consulting services such as compliance monitoring and validation or mapping of transport and storage containers. Our Cold Chain Packaging Division provides packaging development consulting services and thermal packaging products such as coolers, boxes, insulation materials and phase-change products to control temperature during transport. To learn more about Mesa, visit www.mesalabs.com.

CONTACT: John J. Sullivan, Ph.D.; President and CEO, or John Sakys; CFO, both of Mesa Laboratories, Inc., +1-303-987-8000

Easter Visit to Illinois-MC, LSI, MBE Fedegari Meets 4/17-4/18

 

Valued customers,

Life Scientific, Inc., wants to encourage you to reach out and get a hold of our top manufacturers best representatives this Easter in Illinois.

Our lead sales representative MaryBeth Eyer will be in the Chicago, Illinois area after Easter. She’ll be accompanied Joe Walsh, Fedegari’s Sterilization project manager on the Fresenius Kabi Caring for Life Congress. Sterilization plays a big part of patients’ safety and when it comes to the process of making procedures free from bacteria, pathogens and other microorganisms we provide the #1 solutions.

We guarantee to offer something unique in the general healthcare and pharmaceutical manufacturing world, designated to making it a place where the known risks for the end-users and the healthcare specialist are limited to minimum.

Sterilization is a vital part of the everyday life and can be implemented in the food and beverage processing, medicine and surgery, pharmaceuticals and even has its own place in space crafting.

It’s one of the most important processes that can be related to the overall health and wellbeing of the people.

Interested in meeting them and discussing the latest technologies, trends and solutions in sterilization processes call now and request an appointment while there is still time available in their schedule.

Schedule a meeting now and learn more about sterilization from the best first hand by calling Life Scientific, Inc.  Tel: 800-829-5741, 314-752-9400, 3720 Hampton Ave., Ste. 204 St. Louis, MO 63109.

FDA Warning Letter- Hospira Inc

One of the most common reasons for an FDA recall or a 483 warning notice are the inspection failures. There has been an increase in recalls due to visual defects lately. This is driven by recalls for particles, especially glass particles. Increased regulatory activity is pushing an upward spiral with companies taking increasingly conservative actions and recalling batches that would have been acceptable in the past. In the absence of good clinical studies on the risk posed to patients by small numbers of visible particles, we must base any risk assessment on anecdotal reports. It also has led to a wide range of differing practices within the industry, often based on a company’s recent regulatory experience. Among them the most common omissions are in the manual visual inspection of the final product. Beside visual inspection roles being the most responsible work positions, they are among the least liked work duties in a plant.

Manual visual inspection relies on the capability of the inspector, his level of attention and concentration, thus making this role the one that is most prone on mistakes and failures. Big portion of these types of mistakes lays in the size and detectability of the contamination and the level of structure anomalies of the container, because the level of anomalies is often undetectable by the naked eye.

Human manual inspectors, also suffer fatigue and require frequent breaks to maintain a high performance level. These limitations all lead to greater variation in manual inspection results, but this variation can be minimized through good training and operating procedures.

With visual inspection being a mandatory practice, Life Scientific, Inc. offers you a wide variety of visual inspection automation solutions that guarantee, quality, high level of productivity and patient safety.

Installing an automated visual inspection process in your facility over the manual visual inspection will most likely lower the odds of an unwanted 483 warning letters for visual inspection malfunctions or even FDA recalls.

Even the most experienced and the better trained inspectors are prone to mistakes and can fail. Recent FDA warnings and recalls are related to a Pfizer – McPherson affiliated pharmacy, even though the parent network is one of the three PDA licensed companies to provide visual inspection training and testing.

Limit the failures to minimum by upgrading to an automated or semi – automated visual inspection solution.  Have more questions? Leave a comment or send an email to info@Lsi1.com, or contact 800-829-5741.

Life Scientific Midwest trip with Fedegari and Mesa Labs March 13th-15th!

 

Life Scientific, Inc. has some very exciting news. As you know our associates, Fedegari Technologies will be hosting training courses on on Moist & heat sterilization and Steam sterilizers on March 8th and 9th.

Over the past few years we’ve taken part of these courses at Fedegari USA tech center, and we’re pleased to invite you to register for the training seminars. To get an inside view of what will be going on please refer to the brochure.

Starting the Monday after the seminar, our Project Engineer MaryBeth Eyer will be around Illinois, Indiana, Michigan and Ohio. Let us know if we can help you get a hold of her and appoint a meeting. She will also be accompanied by Fedegari’s Sales’ Managers, Hermann Carbone and Sergio Mauri.

Also, we have acquired the Mesa Torqo 1600 demo unit and we’ll be taking it with us, so feel free to get in touch in order to schedule a presentation for any cap torque testing needs you may have.

We look forward to meeting you.

New Fedegari White Paper

Fedegari conducted an R&D study that has been presented at the 2016 PDAA Universe of Pre-filled Syringes and Injection Devices, in California. Developed in collaboration with IBSA Farmaceutici Italy and Amphenol (Kaye), the study has now been transformed in a white paper, “An Innovative Way To Sterilize Hyaluronic Acid PFS.”

Check it out in Fedegari’s Website: http://www.fedegari.com/en/an-innovative-way-to-thermally-sterilize-hyaluronic-acid-pre-filled-syringes/

New Features on Fedegari’s Website

Fedegari has a new website with many new features.
1. Mobile friendly
Choose your device. Our website can handle it.

2. Optimized product search
Search the right equipment by process and loads according to your specific needs.

3. Easy-to-find information on our new LAB and INDUSTRIAL divisions
Our new product pages contain descriptions, videos, image galleries, key-benefits, related white papers, case studies, brochures and related products.

4. Multi-language content
We now have a German version of Fedegari website. In addition, we have added several new pages in Italian and English and we are working to add new languages in the near future.

5. Register for our newsletter
Receive personalized content. Register now!

Check it out here: http://www.fedegari.com/en/5825-2/

Come See Us at the Pack Expo International and Pharma Expo!

The world’s biggest packaging and processing conference and trade show with over 2,000 exhibitors showcasing their most advanced machinery!

Follow here to learn more: http://pharmaexpo.com/

Come see Life Scientific Inc. staff and the manufacturers they represent November 6th-9th. To set up a meeting, call one of your representatives:

  • Mike Bellm (314)941-9000
  • MaryBeth Eyer (217)825-8110
  • Ben Krech (312)545-2164

Bahnson Environmental Specialties (Pharma Expo) West Building Booth W-956
Bahnson Environmental Specialties (BES), an EMCOR Company, is a leading Controlled Environmental Chamber Manufacturer that provides design, installation, service, & validation of standard or custom-built Walk-In Controlled Environmental Chambers for close tolerance temps/RH mainly to the pharmaceutical & research markets.
Bonfiglioli Engineering (Pack Expo) South Hall Booth S-1538
Bonfiglioli Engineering sales staff will be available to answer any question regarding Bonfiglioli Engineering technologies and solutions as non destructive Leak Detection, Visual Inspection and Headspace Gas Analysis for Laboratory and in-line container intergrity testing.
Cozzoli Machine Company (Pack Expo) South Hall S-2142
Cozzoli Machine Company will be exhibiting their latest filling and closing technology. Featured machines includes the FSV50 Mini Monoblock, the FPS2-SS Ampule Filling & Sealing Machine, and the Versa Fil Time Pressure Filler. They will also show some tabletop equipment including our F400X Single Piston Liquid filler and the PF2IS powder filler, confirgured for use in an isolator.
Mesa Laboratories (Pack Expo) East Hall Booth E-10632
Mesa Labs is the world’s leading cap torque testers for every type of bottle. Please stop by their booth If you are interested in a live demo of the latest in cap torque technology, or a free consultation!
Newman Labeling Systems (Pack Expo) South Hall Booth S-4382
Newman Labelling Systems, a leading supplier of specialist pharmaceutical labelling systems, will be demonstrating its CTE350 automatic labeller and will preview a new Print & Apply labeller.

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