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

Happy Independence Day !!!

              The Life Scientific Inc  ( LSI ) team would like to wish our valued customers a happy 4th of July.

 

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. “

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

 

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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.

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Internal view -Steam sterilizer integrated with a sterility test isolator

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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

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.

Drug Serialization — The Key To Protecting Patients In U.S. And International Markets

Evolving track-and-trace rules in key markets are driving pharmaceutical industry demand for adaptable contractors with regional expertise, according to Ian Parsonage, Senior Director, Global Serialization Services at PCI Pharma Services.

Beginning in late November 2017, pharmaceuticals sold in the U.S. must be marked with a National Drug Code (NDC), a serial number, a lot number, and an expiration date. The requirement, stipulated in 2013’s Drug Quality and Security Act (DQSA) (H.R. 3204), is designed to harmonize existing state-to-state variations in track-and-trace laws.

The idea is to eventually establish a nationwide tracking system to secure supply chains and accelerate the identification of substandard and counterfeit products. Another aim is to provide manufacturers with clear guidelines on how their products should be marked.

How effective the new laws will be remains to be seen, but what is certain is that drug makers that supply multiple countries will soon have another set of market-specific requirements with which to comply.

Read more here: http://vertassets.blob.core.windows.net/download/d0b6e29b/d0b6e29b-9dd6-49d8-b202-140e0a0fc1ec/pci_drug_serialization.pdf

 

Please visit our manufacturer exhibiting AT INTERPACK 2017

Hall 15, Stand A10

Dusseldorf, Germany 

4 – 10th May

Hall 15 / A10

NEWMAN LABELLING

FMD COMPLIANT SYSTEMS 

 

With the Falsified Medicines Directive coming into force in February 2019, this year’s Interpack in Dusseldorf, Germany, 4-10th May, will see Newman Labelling focussing on its labelling systems’ Track and Trace compatibility.

 

A working S350 fully automatic labelling system will be demonstrated at Interpack with a Vision System and Newman’s unique Faulty Label Removal System. The combination of quality machine engineering, accessories including a wide range of printing and inspection systems, plus comprehensive validation support provide customers with a labelling system that is fully able to meet the requirements of the Falsified Medicines Directive.

 

The S350 has been designed to operate 24/7 at a true production rate of up to 300 containers per minute with high levels of efficiency according to DIN 8743. It is capable of applying both paper and clear plastic labels to cylindrical containers in glass, plastic, metal and composite materials. Both label and container size changes can be rapidly achieved without the use of tools and digital scales provide repeatable container changeover in minutes.

 

A compact cGMP Design, manufactured in stainless steel 304 finish, the S350 comes with a range of features as standard, such as ‘Auto-teach’ label length facility, a positive accept security system and In Process Control.

Interpack 2017 marks the first major show for Newman’s newly appointed Managing Director Shaun Baker.
Since starting at Newman in March I have been immersing myself in the business. Interpack will be my first chance to meet a wide range of Newman’s customers and partners from around the globe, so is an excellent relationship building tool as well as a key sales opportunity.

 

Be sure to visit Newman Labelling Systems at this year’s Interpackin Hall 15, stand A10.

 

FAULTY LABEL REMOVAL SYSTEM

 

A further enhancement to Track & Trace requirements comes in the form of Newman’s unique Faulty Label Removal (FLR) System with its automatic controlling of reject labels, which will also be demonstrated at Interpack. In operation, should the FLR system not receive “good signals” from the scanning / security devices in use (including bar code reader, missing overprint detector, OCV camera and 2D matrix code reader), the faulty label is securely removed from the label web prior to application onto the container. These faulty labels are then transferred to a paper roll for batch reconciliation and inspection.

 

Established in 1943, Newman Labelling Systems has a customer base that includes the world’s top ten pharmaceutical companies. The company provides a combination of excellent service, accuracy and reliability of equipment, quality and speed of validation, plus the capability of engineers and staff experience. Newman Labelling Systems’ purpose built systems are fully compliant with FDA cGMP requirements and can be supplied with validation completed up to PQ.

 

 

PDA Journal of Pharmaceutical Science and Technology

Mr. Andrea Simonetti (Senior Manager, Strategic Initiatives at Bonfiglioli Engineering) and Mr. Filippo Amari (Continuous Improvement Manager at Novartis Vaccines) authored an article on presenting an unprecedented case study conducted on Pre-filled Syringes. This work is an example of excellent collaboration between the two companies.
The following link takes you to the article published on the 2015 January/February issue of PDA Journal of Pharmaceutical Science and Technology: http://journal.pda.org/content/69/1/108. If you need more information on this, please contact us.

The case study presented in this publication, investigated the capability of four CCI testing methods to detect simulated defects of different sizes and types on glass syringes, prefilled both with drug product intended for parenteral administration and sterile water. The drug product was a flu vaccine (Agrippal, by Novartis Vaccines, Siena, Italy). Vacuum Decay, Pharmacopoeial Dye Ingress Test, Novartis Specific Dye Ingress Test and High Voltage Leak Detection were, in succession, the methods involved in the comparative studies. The case study execution was preceded by the preparation of two independent sets of reference pre-filled syringes (PFS), classified, respectively, as examples of conforming to closure integrity requirements (Negative Controls) and as defective (Positive Controls).

Positive Controls were, in turn, split in six groups, three of which with holes laser-drilled through the PFS glass barrel, while the other three with capillary tubes embedded in the PFS plunger. These reference populations were then investigated by means of validated equipments used for CCI testing of the PFS commercial production; data were collected and analyzed to determine the detection rate and the percentage of false results. Results showed that Vacuum Decay method had the highest performance in terms of detection sensitivity and also ensured the best reliability and repeatability of measurements. An innovative technical solution, preventing possible PFS plunger movement during CCI testing execution, was presented as well.

 

Source: http://www.bonfiglioliengineering.com/news-events/460/pda-journal-of-pharmaceutical-science-and-technology.html