BONFIG LASERCUBE Live Demos

Overview

The BONFIG LASERCUBE from Bonfiglioli Engineering is a bench top system for performing Headspace Gas Analysis (HGA) analysis of sterile pharmaceutical containers, such as cartridges, ampoules and pre-filled syringes.

It provides a non-destructive, non-invasive laser-based inspection solution for leak detection and container closure integrity testing (CCIT) by measuring the headspace level of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

Design & Features

BONFIG LASERCUBE uses an inspection method created to meet specific customer requirements for s user-friendly solution to needs for ampoule, cartridge and pre-filled syringe leak testing and HGA.

The non-destructive, non-invasive laser-based inspection system is designed to measure the headspace levels of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

HGA is an ideal solution for accurate investigation of translucent containers and pharmaceutical finished containers, as well as headspace conditions for products packaged under modified atmosphere and closure integrity.

The BONFIG LASERCUBE measuring system ensures extreme stability and accuracy in inspection even where headspace is limited.

This is a compact and lightweight system that is easy to use and set up via integrated PC or any wireless-connected touchscreen tablet or smartphone.

The technology is designed to make Etalon effect negligible. It also removes any need for nitrogen purging during oxygen measuring.

User benefits:

BONFIG LASERCUBE is designed to meet the needs of Quality Assurance, Production, Maintenance, Production or Laboratory analysts in pharmaceutical companies producing sterile products. The solution delivers an impressive set of user benefits:

  • Non-invasive and non-intrusive inspection method
  • Near elimination of Etalon effect
  • Fast, reliable and repeatable results
  • Nitrogen purging not required during oxygen measuring
  • Compact and durable design
  • Maintenance-free
  • Quick changeovers
  • Cost-effective solution with low power consumption
  • Fully automated test cycle sequencing with manual loading and unloading of containers
  • Data can be stored and exported (production, raw data, events, alarms)
  • Enhanced easy-to-use HMIU integrated functions
  • HMI real time display of statistics and raw data
  • Validation package guarantees complete and efficient regulatory compliance

 

All TASITEST computerized systems are engineered to comply with FDA 21 CFR Part 11 and EU Annex 11.

Live demonstrations

Bonfiglioli Engineering formally launched the BONFIG LASERCUBE at the Interpack 2017 exhibition in Dusseldorf.

The Laser Cube debut in USA is going to be at this year’s Pack Expo Las Vegas at TasiTest booth N-209 therefore we invite anyone interested in the system to attend live demonstrations at the TASITEST’s booth.

Demonstrations will take place every morning and afternoon on each day of the show, if you want to get more up close and personal with this equipment schedule a demo at your facility at time that is most convenient for you.

 

 

Reservations for demonstrations can be made by emailing or calling Life Scientific, Inc. at:

MaryBeth:

Email: marybeth@lsi1.com                                               Phone: +1 800-829-5741

Piero:

Email: ppolastri@tasitest.com                          Phone: +1 414-335-5973

GET A FREE TICKET AND VISIT OUR MANUFACTURERS AT THIS YEAR’S PACK EXPO LAS VEGAS

Bahnson Environmental Specialties
North Hall – Booth #304

The highest demanded Reach-In Environmental and Photostability Chambers in Vaccine storage.

 

Newman Labeling Systems Inc.
North Hall – Booth #437

Newman’s newly appointed Managing Director Shaun Baker will be in attendance.  Newman Labeling Booth is offering a Special Pack Expo 18% discount.

 

 

TASI Test Group
North Hall – Booth #209

TasiTest, leading specialist of packaging leak detection solutions, will showcase its latest product developments at Pack Expo Las Vegas on booth 209 in the North Hall.

 

Cozzoli Machine Company
Central Hall – Booth #2006

Cozzoli is exhibiting the FSV50 Mini Monoblock, the FPS2-SS Ampule Fill & Seal Machine. They’ll spotlight their tabletop equipment.

 

 

Vetromeccanica S.r.l. – Conveying Solutions
Stefano Lodi, in Attendance

Specialized in conveyors and accumulating tables for loose and packed containers, make sure to connect with Stefano who will provide details on their fleet of Conveying systems. Contact Stefano beforehand to schedule a meeting by emailing him:
s.lodi@vetromeccanica.it

 

Aseptic Enclosures
Represented by Joe Skorcz,
in AttendanceIf you would like to meet with Aseptic Enclosures during Pack Expo to discuss any projects we can help you with, please contact our attending representative Joe Skorcz prior to 9/24 at:
o. 800-829-5741
c. 312-545-2164
JoeS@Lsi1.com

To get a Free ticket for this year’s Pack EXPO Las Vegas, follow the link bellow and register yourself as an attendee using the comp code: 43D42

http://bit.ly/PackExpoLV17

Enter it in the “comp code” box during registration.

By entering the code we provided you get your PACK EXPO ticket free of charge! By entering our code the ticket fee will be removed at check-out, where the fee will be waived automatically.

Meanwhile take a note of our Manufacturer’s Booth locations and our Reps in attendance and do not hesitate to get in touch.

Defining “Primary” Gas Flow Technology

All gas flow calibrators are not the same. Not only do the products vary, but the technology may as well. A calibrator that uses the International System of Units (SI base units) of time and length to derive gas flow measurements can be considered “primary technology”. Secondary technologies use proxy methods such as differential pressure to assume gas flow.

The seven SI base units are length, time, mass, electric current, thermodynamic temperature, amount of substance, and luminous intensity. Since there is no SI base unit for the direct measurement of gas flow, the base units of time and length are used to calculate flow rates.

Mesa’s DryCal technology uses a glass tube with a precisely known volume and a moving piston that triggers light sensors. Thus, the working principles of DryCal technology use the SI base units of time and length to calculate gas flow, making it one of the only primary technologies on the market.

When considering gas flow calibrators, be sure to look for an instrument that provided accurate, reliable, primary gas flow readings. Consider a name you can trust, such as DryCal from Mesa Labs, with over a quarter century of experience in the flow calibration industry.

Want to learn more about the science behind Mesa’s Primary Gas Flow Calibrators? Watch this video.

Source:

http://www.industrialhygienenews-digital.com/industrialhygienenews/summer_2017?pg=18#pg18

Vetromeccanica S.r.l. – Conveying Solutions Attending Pack Expo

Specialized in conveyors and accumulating tables for loose and packed containers, make sure to connect with Stefano who will provide details on their fleet of Conveying systems. VetroMeccanica also offers conveyors for products which require a specific and more tailored design.

Vetromeccanica Srl has been engineering and producing bottles conveyors since 1992.
Starting as a glass bottle conveyors manufacturer Vetromeccanica has been continuously extending its field of expertise and in the ’90 became one of the world leader manufacturers of air conveyors for PET bottles.
The company offers nowadays a comprehensive range of conveyors for both primary and secondary packaging. Conveyable products go from yoghurt cups to toothpaste tubes varying from beverage, food and chemical industry.
 

Stefano Lodi, Vetro Meccaninca Business Development Manager will be in Attendance. Contact Stefano beforehand to schedule a meeting and discuss projects concerning Vetro Meccanica product line by emailing him: s.lodi@vetromeccanica.it

 

Contact Stefano Lodi and set up a time and date for a meeting since his schedule is very tight.

 

Cozzoli with their signature line at PackExpo 2017

 

At this year’s Pack Expo Las Vegas, Cozzoli is showcasing their best sellers, products with proven quality, well known throughout the industry, dependable and widely spread on the US market. Featured at Discovery Channel’s “How It’s Made?” show multiple times.

 

Cozzoli is exhibiting the FSV50 Mini Monoblock that accommodates a compact space, with hood isolation and laminar flow in mind, utilizing the least amount of space for use in a clean environment.

The Cozzoli FPS2-SS Ampule Filling & Sealing Machine, best known for its versatility, simplicity of design, accessibility of parts and minimal changeover time needed for successful operation of these dependable machines.

They’ll also spotlight their tabletop equipment including F400X single piston liquid filler and the PF2IS powder filler, configured for use in an isolator and specially designed to provide moderate production output in a batch filling operation.

 

Stop by Cozzoli’s booth in the Pack Expo Central Hall, Booth C-2006 and see for yourselves why Cozzoli has been a very dependable manufacturer of technologically advanced machinery for almost a century.

 

Any requests, questions or inquiries can be addressed to Joe Skorcz who’ll be also attending the Pack Expo.

  1. 800-829-5741
    c. 312-545-2164
    JoeS@Lsi1.com

DialyGuard Meter Rental Program from Mesalabs

 

Mesa Labs offers its customers the ability to rent various replacement meters while theirs are being calibrated. Keeping meters calibrated and in compliance is paramount in proving the safety of the procedures being performed.

All of Mesa’s medical products are manufactured and maintained under ISO 13485 certified procedures, allowing customers to be certain that Mesa’s high quality and technical standards are in place. Mesa recommends annual calibration of all DialyGuard meters.

The rental program creates an efficient cycle of convenience by allowing one customer to use the rental meter for a period while their meter is in for calibration, and upon return that same meter can be sent to another customer in need.

The associated monthly fees for renting a meter from Mesa are below:

 

Meter Model (price/meter*)

pHoenix Neo-Stat+ HYDRA
$75/month $75/month $75/month
90XL Display 90XL Condo/Temp 90XL Press. 90XL pH
$80/month $50/month $50/month $50/month

 

 

*US and Canadian Pricing Only                    Minimum 1-month rental required

 

 Click here to view the 2017 Service Pricing Form.

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. “