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.

Driving Change In Pharmaceutical Packaging-Newman Labelling

With the Falsified Medicines Directive coming into force in 2019, now is the time to re-evaluate the efficiency of your production lines to ensure they will cope with the extra demands the Directive will place on them.

In July 2011, the EU adopted the Falsified Medicines Directive in a concerted effort to protect patients and consumers from falsified medicines which may contain ingredients of low quality or in the wrong doses; be deliberately and fraudulently mislabelled with respect to their identity or source; have fake packaging, the wrong
ingredients, or low levels of the active ingredients. As you might expect, falsified medicines do not pass through the usual evaluation of quality, safety and efficacy, which is required for the EU authorization procedure. Because of this, they can be a very real health threat.  The Falsified Medicines Directive doesn’t comes into force until February 2019 but EU member states are under an obligation to start implementing the measures laid out in the Directive.

 

 

For pharmaceutical manufacturers, contract packers and distributors – indeed all those involved in the supply chain –
the new Directive is momentous. Whilst there have already been requirements for certain information to be included on the packaging, the Directive will require organisations to be able to proficiently handle vast amounts of extra data. That data doesn’t just need to be stored and archived, but will need to be applied to medicine packaging and read at high speeds. With the new Directive, every individual pack of medicine must be marked with a unique, non predictive serial number with information that can be read by people and machines; previously only data pertaining
to the batch was required, but the onus has now changed to each and every individual container. The unique identifier must be placed in a 2D barcode and contain the product code, a serial number, the national reimbursement number (if requested by Member States), the batch number and the expiry date. Each serial number must be registered with a pan European database.

Read more here: http://www.newman.co.uk/download_pdf/Driving-Change-In-Pharmaceutical-Packaging.pdf

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

Fresenius Kabi Specify Newman Vial Labeller For Reliability And Output

Newman Labelling Systems, a leading manufacturer of pharmaceutical labelling systems, has supplied a 6VAL labelling system to health care company Fresenius Kabi for use in their Port Elizabeth facility in South Africa.

The 6VAL labelling system is designed to apply both clear and paper self-adhesive labels to a range of rigid cylindrical containers. At Fresenius Kabi it is being used to label 2ml vials of PETOGEN 150mg/mL Injection. The well proven 6VAL container handling system is specifically designed for handling unstable containers such vials, in addition to ampoules, syringes and cartridges, at speeds of up to 275 containers per minute.

The 6VAL has been supplied by Newman with a PCE Pilot Optical Character Vision and Optical Character Recognition system and a Videojet Dataflex Thermal Transfer Coder with colour screen for printing batch and expiry dates.

Fresenius Kabi’s decision to purchase the 6VAL was based on a combination of machine quality and capability, plus the reputation of Newman Labelling Systems both within the company and the industry at large. Jeremiah Thorne, Project Engineer at Fresenius Kabi, explains: “We were impressed by the output capacity of the machine, the presence of a unit rejection station, 2D barcode scanning option and the fact that it is cGMP compliant. We also liked Newman’s ability to supply the machine with OCV and OCR options.

“The other consideration in our decision was the brand name and the manufacturer’s expertise when it comes to developing and manufacturing labelling equipment for vials and ampoules. Newman’s machines have proved to be reliable and Newman has always provided a professional, efficient and helpful service, which has led us to standardise on them in our factory. “

THE GEOMETRY OF A PROCESS VESSEL- JVNW

The Complete Process Vessel is one where all components are perfectly matched for efficiency and performance. Cleaning devices must reach every corner but must not interfere with shafts and impellers. Instrumentation must be properly located to avoid false readings. Heat transfer jacketing must be sized for batch loads or zoned for flexibility. The same mechanical engineering talent that invented the patented Sanifoil and Easy Change SaniBearing steady bearing (patented 2008) continually solve the most difficult processing challenges. Instrumentation, mixer and vessel are designed as one, and undergo complete performance testing prior to shipment. JVNW pre-validation support is thorough and on time.

 

 

  • WFI Vessels
  • Bioreactors
  • Portable Transfer Vessels
  • Sterile Surge Vessels
  • Fermentation Vessels
  • Bio-storage Tanks
  • Kettles
  • Pilot Scale and R&D Vessels
  • Agitation Systems

ONE SOURCE

  • Mixer Laboratory
  • Ultra-sanitary Sanifoil Impeller,
  • solid shafts
  • Factory electropolishing
  • Controls, instrumentation, wiring:
    • level
    • temperature
    • pressure
    • ph
    • DO
    • conductivity
    • RPM sensors
    • displays
    • pressure relief
  • Complete mixer installation
  • Cleaning devices, fixed positioning, testing
  • Mixer and tank performance tested prior to delivery (FAT)
  • Pre-validation documentation packages

ASEPTIC PROCESSES: TECHNOLOGICAL INNOVATIONS ON A3P BARRIER TECHNOLOGY DAYS

ASEPTIC PROCESSES: OUR TECHNOLOGICAL INNOVATIONS

 

Barrier systems are developed and continuously updated technologies that reduce the risk of contamination during sterile aseptic manufacturing by “containing” direct human intervention in critical areas.

 

For the third consecutive year, the A3P Association has planned to dedicate two days of conferences on Barrier Technologies.

 

STERIGENE, our long-term partner and a major player for process equipment and contamination control, will be proudly receiving visitors on stand N ° 7.  Accompanied by Sergio MAURI, Manager, Global Integrated Projects at FEDEGARI GROUP, the STERIGENE team will present its technological innovations in aseptic processes and pharmaceutical isolators.

 

Featured products: Fedegari Sterility Test Cabinet – FCTS / Fedegari Isolator FCIS

 

FCTS – Fedegari Isolators for Sterility Testing

 

The FCTS isolator is a GMP process equipment equipped with a built-in H2O2vaporizer engineered and manufactured by Fedegari. It is mainly used for the sterility testing of pharmaceutical and cosmetic products.

Unstisfied with the performance and reliability of third-party hydrogen peroxide vaporizers, Fedegari has installed the same solutions that were standardized for its bio-decontamination units that do not require any proprietary consumables.
This innovative design provides real time biocide concentration control (over traditional estimate d calculations) and is managed by the very same Thema4 process controller which is today’s reference standard for all contamination control machines.
Through the H2O2 sensors, Thema4 assures that vapor concentration
remains extremely constant (within ± 15 ppm) thus making process repeatability
the logical consequence.

 

Download the complete product presentation – FCTS

 

017-sterility-test-cabinet-fedegari-copia

FCIS – Fedegari Isolators for aseptic processes

 

One of the special features of the Fedegari isolators (FCIS) is the possibility of coupling the equipment with a saturated steam autoclave or a chemical bio- decontamination with H2O2 lock, in order to create an aseptic transfer process for the complete sterility tests according to the GMP principles. The integration of these systems (sterilization + isolator / bio-decontamination + isolator) is a cost-effective solution for controlling the cross-contamination often induced during intervention of operators in critical zones.

 

In the pictures below you can see a moist-heat sterilizer (autoclave) integrated with a sterility test isolator for aseptic processing.

fof-fcts-dettaglio-019-2-2

Internal view -Steam sterilizer integrated with a sterility test isolator

fof-fcts-05-2-2

Steam sterilizer integrated with a sterility test isolator

 

 

If you need more information about the participation of STERIGENE & FEDEGARI in the A3P Barrier Technology Days or on our FEDEGARI aseptic process equipment, please contact us: sterigene@sterigene.com or fedegari@fedegari.com

 

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

Cozzoli Threadless Syringes

Cozzoli developed their threadless syringes to reduce mounting time, cut down cleaning time, and totally eliminate the possibility of cross threading.

All new Cozzoli/MRM machines will include these syringes.

This upgrade can be retrofitted easily to existing machines.

Parts Sale Reminder
  • 10% discount on parts for your summer shutdown.
  • Discounts on preventive maintenance
  • Consultation service call comped when recommended action taken *

Call us today and get your Cozzoli and MRM machines running with maximum performance!

Contact our Customer Service Department to find out how:
call 732-564-0400 or email custserv@cozzoli.com.

BES Environmental Chambers

 

Bahnson Environmental Specialties offers a complete line of reach-in chambers for these industrial, research, and life science applications. Bahnson offers a range of environmental chambers designed for high demand testing, processing, or conditioning. The ES2000 product line includes six standard models. Standard temperature capabilities range from –20°C to 70°C, with controlled humidification, lighting, and CO2 available. Other performance options are available (refer to Options & Accessories).

 
General features include:
•  User friendly touchscreen control system
•  High performance electronic and mechanical systems capable of accelerated heating, cooling, and recovery rates.
•  Industrial-grade cabinet construction for continuous use in research, process, or storage.
•  Heavy-duty refrigeration system featuring reserve heat removal capacity for quick response to door openings, internal heat loads, or unstable ambient conditions.

 
The ES2000 series are setting higher standards in the reach-in stability chambers segment. The product line is fully applicable to HEPA filtered cleanroom and compliant to both all cleanroom standards.
Bahnson’s ultra-low temperature freezers are built in compliance with all of the latest standards and necessities of a modern pharmacy. All ES2000 freezers feature double wall chamber, reinforced stainless steel shelving, user-friendly temperature & humidity touchscreen control system. The control and management system features a high-end independent alarms for temperature and humidity. All this is topped off by a precise air control system that ensures conditioned air is distributed uniformly across your product shelves.

You can’t anticipate running a high end compounding pharmacy at your facility without a Bahnson Environmental Specialties Freezer.
Luckily we are here to help and get the best quotes for your facility. Contact Life Scientific, Inc. right away by calling 800-829-5741.