FIRST ISSUE ONLINE MAGAZINE BY BONFIGLIOLI ENGINEERING IS OUT

2019 is a new era for Bonfiglioli Engineering, with many new and exciting developments: expansion of the headquarters to a new and bigger site, structural reorganization and emphasis on customer care, focus on education and consultations for our clients, and other pleasant surprises planned for the year.

All this news and more will be collected & presented to all our stakeholders, every three months via the B.E. Inspection Post, the new informative journal from Bonfiglioli engineering. The B.E.Inspection Post contains a wide range of arguments like technology insights, what’s happening inside B.E., an interview with team members, contributions by our stakeholders, book suggestions, upcoming events, case studies and lots more.

It is the people’s magazine and the articles have been written by diverse team members of Bonfiglioli Engineering. It is also your contributions that have made this magazine so rich. Thank you.

The B.E.Inspection Post represents our company and each one of us. This is our way of being closer to you, our Clients, Employees, Partners, Suppliers and sharing a part of ourselves with you.

Get your Copy from HERE

We sincerely hope you enjoy reading it.

Do send us your feedback.

Cozzoli at Interphex 2019!

INTERPHEX 2019 IS ONLY A MONTH AWAY!

Come visit us at booth #2805 in New York, NY on April 2-4. Make sure to use the link below to get your free attendee badge.

https://www.compusystems.com/servlet/ar?evt_uid=381&utm&utm_source=cmv3-exhibitor-current&utm_campaign=CIP-04-02-19&utm_medium=email&utm_term=FREE01134&utm_ref=Cozzoli-Machine-Company

We look forward to seeing everyone at the show!

If you want to schedule a meeting or request a free pass, do not hesitate to connect with our project managers or call our office at 800-829-5741

Introduction to Single Dose Packaging

The introduction of single dose packaging has become a breakthrough across a diverse variety of applications and industries. Single dose packaging, also known as unit dose packaging, has given hospitals, pharmaceutical companies, and patients more control over their medication while simultaneously reducing waste. It’s also become a popular commodity used by cosmetic manufacturers due to its small, easy to carry unit size.

So what makes unit dose packaging such an innovative development in the packing field? What benefits does single dose packaging provide companies and how is it best utilized? The purpose of this article is to answer these questions thoroughly while covering the many advantages incorporating unit dose packaging in various applications. Keep reading to learn why a unit dose delivery system might be perfect for your product.

Advantages of Single Dose Packaging

As implied by its name, a single dose package safely holds a single premeasured unit of a particular medicine or substance. Having a dose already measured out eliminates the possibility of human error while adding convenience for the user during application. Moreover, its materials are made of eco-friendly bioplasticfrom 100% renewable sources, reducing our dependence on diminishing resources and lessening waste.

The advantages of single dose packaging in clinical and hospital settings are as follows:

  • Improved application accuracy for patients and personnel
  • Reduction in waste and unnecessary bottles and containers
  • Barcodes that identify each individual dose
  • Easily identifying tampered or broken packages
  • Patient is only responsible for exact doses delivered
  • Simple electronic documentation capabilities

There is an obvious advantage for people to have their medication already measured out prior to administration. There are, however, also other advantageous benefits that have since become widely utilized by other forward-thinking businesses in a wide range of other industries. Because of its diverse functionality, unit dose packaging is also now commonly found utilized in cosmetics, OTC products, veterinary and animal care, and even diagnostics.

More Single Dose Packaging Applications:

In cosmetics, health and beauty products are often handed out as samples for consumers to try. Utilizing the convenient size and protection of unit dose packaging, handing out lotion, gel, perfume, or other samples in an easy-to-carry, premeasured package has never been more effective. Similarly, diagnostic test kits in single dose containers eliminate potential human error while increasing the convenience for personnel.

As more businesses discuss the benefits of incorporating innovative packaging into their brand, surely even more uses will continue to develop. One such recent market that has grown to embrace its advantages is packaging for CBD products. If you, too, believe unit dose packaging might be right for your product or application, contact us today. We’ll gladly assist you and tell you how to receive some free samples filled with your product. Call 800-829-5741

PK series Inline Container Closure Integrity Test Machines

A complete range of products that covers all nominal production throughput/ speed of production lines.

Each Machine is designed for Non-Invasive, Non-Destructive Integrity Testing of diverse type of Pharmaceutical Containers and Contents. It is conceived for 100% in-line testing at high production speed. Testing is fast, reliable and repeatable, giving consistent results and allowing for full batch control without altering the container or content features.

Vacuum Decay or Pressure Decay Methods allow to reach full compliance with current GMP international regulations.

High class mechanical design and automation solutions fit for the purpose to perform, ease service and avoid downtime.

Equipment has full capability to be integrated in Industry 4.0 environment with Electronic Batch Record management or Manufacturing Execution Systems.

MULTIPLE FORMAT, CONTENT TYPE AND SIZES MACHINE

With the same machine, various tests are available; in terms of contents: liquid, lyo and powder and in terms of containers: wide range of sizes. High quality handling system, comprising State of the art electronic actuators and motor inverters, as well as high class mechanical design allow high machine adaptability to line output variations. Optimal testing results are achieved at nominal speed and also in case of speed reductions and increases.

HIGH FLEXIBILITY INSTALLATION

High machine installation flexibility, by means of rotating tables or other systems like tray loading, it is possible to install the machine in-line, off-line or next to the production line.

REPORTS & DATA MANAGEMENT

Production, test and alarms reports are printable either local or network printer. Testing and production data are downloadable on USB driver and printable either local or network printer.

STATISTICAL PROCESS CONTROL

Statistical Process Control is conceived to give full support to the quality system, maintenance and process control staff. It allows to improve control ability and to have a constant evaluation of the manufacturing processes, keeping track and analyzing the collected data on different time frames. This brings to reduced deviations and basically helps to improve the yield. Features of Statistical Process Control are: – Trend analysis – Alarm Statistics – Histogram Graphs – Run Charts (X and R) Giving statistical representation of measurement acquisitions, it is possible to calculate significant process parameters (Avg, std.dev., Cp,Cpk). From another perspective, it also saves the historical data for comparison, gives quick access to most frequent failures both of the GMP critical, business and safety ones. Pareto diagrams representations allow to highlight the most relevant failure modes, calculating Statistical parameters (i.e.: MTBF – Mean Time Between Failure and MTTR – Mean Time To Repair).

REGULATORY COMPLIANCE

Equipment test method complies with:

FDA Guidance for Industry “Container and Closure System Integrity Testing in Lieu of Sterility Testing

 as a Component of the Stability Protocol for Sterile Products”.

United States Pharmacopoeia General Chapter «1207» “Packaging Integrity Evaluation”.

EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”.

PDA Technical Report No. 27 “Pharmaceutical Package Integrity”

FDA 21 CFR Part 11 and EU Annex 11

DATA INTEGRITY

The system generates the following logfiles: Production report, Tests report, Events report, Alarms report. Complete and accurate historical data copies are available through the use of a viewer utility on Report graphical pages (accessible as read-only) and can be downloaded. Electronic data which are stored into the System cannot be deleted or changed by any user. Electronic signature is available for verification and authorization of most critical process steps.

HMI Operator interfacing is featured by a SCADA System made up of interactive graphical pages allowing to: – Manage Electronic Records, Operators accounts and System accesses – Report and record Operator critical actions, process activities, anomaly conditions (Audit Trail) – Control Testing Process and access to online Troubleshooting – Set Machine critical parameters (Recipes, Operators, Configuration) HMI Real Time display of Leak Testing Cycle diagram.

GAMP 5 COMPLIANCE Equipment computerized system is designed according to ISPE GAMP 5 guidelines.

TEST METHOD

Machine Leak Testing Measurement System follows the approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”. The Test method is a Recognised Consensus Standard by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), effective March 31, 2006 (Reference: Federal Register Notice FR Notice (list #014) [Docket No. 2004N-0226].

AUTOTEST

Autotest function has the aim to verify the measurement system capability to detect leaking Containers simulating a Calibrated Leak. This function is useful and applicable during qualification stages as well as during usual production cycle, to automatically confirm proper functioning and behavior of each testing chamber.

RELATIVE TRANSDUCER FUNCTION

Relative Transducer Functionality Algorithm Checking every Relative Transducer both for incorrect Atmospheric Pressure Reading and for overpressure. The monitoring operation is executed in continuous during run-time.

AUTOMATIC DRYING SYSTEM

This system automatically dries each Testing Chamber which might have been contaminated by liquid or moisture left by leaking Containers. To avoid the possibility of producing false rejects, it is necessary that every potentially contaminated Testing Chamber is brought back to its optimal state of operation before this is allowed to test other Containers. With A.D.S. enabled, Containers are not fed into the Testing Chamber to be dried but passed on to the next available one. As a result, this particular Chamber will perform an empty cycle during which a continuous vacuum dries it. Whilst under vacuum, any residue will be evaporated, therefore drying the Testing Chamber.

BAROMETRIC COMPENSATION ALGORITHM

This system has the function to avoid variations in Pressure readings coming from the Relative Transducer by means of compensating any changes due to atmospheric pressure fluctuations.

TEMPLATE URS

Support to customer’s URS development for specific application to reach, considering a common definition (customer and supplier), the best possible solution.

AUTODIAGNOSTICS

Autodiagnostics automatically verifies the optimal working condition of: Pressure and Exhaust Electrovalves, Relative Pressure Transducers, Testing Chamber (in terms of airtightness). Autodiagnostics is automatically enabled at Machine Start-Up and can also be manually activated while Machine is in production phase, pressing a dedicated button on the HMI. Container feeding to the Central Carousel is mechanically blocked during the Autodiagnostics execution.

VALIDATION PACKAGE

Machine Qualification and Validation complies with requirements stated in EU Annex 15. Validation Package guarantees complete and efficient regulatory compliance. Standard Validation Package includes: Project Quality Plan, Functional Design Specifications, Mechanical/  Hardware / Software Specifications, FAT /SAT, IQ and OQ. Moreover, following documents are available for delivery: Performance Specifications, Performance Qualification, Design Qualification, 21 CFR Part 11 Compliance Table, Traceability Matrix to supplied URS.

Plastic Vials For Injectables

The use of glass ampoules has been the most common standard for containing sensitive pharmaceuticals and biotech products since its inception over a century ago. However, with the proliferation of more innovative packaging solutions, many pharmaceutical manufacturers are adopting plastic vials for injectables due to the reduction in drawbacks attributed to packaging products in glass containers.

LF of America is an innovative packaging company intent on delivering new solutions that meet the challenges faced throughout the pharmaceutical industry. We’re proud to announce our latest solution for reducing the contaminant concerns and fragile qualities of glass containers, challenges pharmaceutical manufacturers and industry workers encounter regularly. Our new plastic vials with luer lock fittings for injectables are a safe and practical alternative to glass ampoules and prefilled syringe storage.

Benefits Of Plastic Vials For Injectables

Vials storing injectables are required to meet strict regulatory standards for product safety assurances. Although glass ampoules have excellent barrier properties, chemical resistance, and remain generally compliant, the increasing demand for lightweight and durable pharmaceutical packaging options continues. The fragility of glass, along with drug and container interaction concerns, has led to a growing interest in plastic vials designed to efficiently fill, ship, store, and administer injectables safely.

What our new plastic vials provide manufacturers and industry professionals is the ability to achieve all of these goals without the dangers associated with glass storage. From production to administration, every step of the process can be assisted by the dependability of this innovative packaging option. Designed with a luer lock fitting, the empty syringe screws directly into the luer on the vial for safe liquid transfer. Once the content exchange is completed, the vial can be disposed of while the syringe is prepared for administration via a needle or directly.

The benefits of adopting our new plastic vials for injectables include:

  • Eliminating glass breakage during filling, shipping, storage, and administration
  • Less risk of drug/ container interaction
  • Lightweight, break-resistant materials
  • Greater design flexibility
  • Less space needed for product storage than prefilled syringes

The plastic vials for injectables are designed as unit-dose packaging systems in 5-vial strips. Currently available in 10 mL and 20 mL capacity, each plastic vial can also be designed to hold the precise measurement for the appropriate single dose amount in any container size required.

Filling Plastic Vials For Injectables

LF of America is proud to be a turnkey contract packaging and filling company. We provide contract filling services using state-of-the-art machines equipped with fill and seal and injection molding technology. Each fill is performed inside a completely sterile ISO-5 environment for quality and safety assurance. In addition, our filling machines are available to buy directly for manufacturers and companies looking to incorporate their own in-house packaging solution.

To discuss our contract packaging and filling services or for other questions regarding our new plastic vials for injectables,  please call our offices and connect to our project specialists 800-829-5741

Fedegari Exhibiting on the Interphex

UNCONVENTIONAL TURN-KEY SOLUTIONS
We are getting ready to showcase our latest developments on contamination control to help customers achieving cost-effectiveness with the best performances on pharma manufacturing. 


You will be able to see the integration of different Fedegari processes and technologies, but not only. 


Come and visit us at Interphex New York, Javits Center – Booth #3461!

Call our office today and pre schedule a private meeting during the tradeshow. Contact 800-829-5741 today.

Fedegari’s Appearance at Conference Lab Conversion Industry 4.0

Fedegari Global Plants Director, Marco Gonnella was interviewed while taking part at the roundtable ‘MANUFACTURING 4.0’ promoted by Conference Lab, last November 12th in Milan.

The participants at Conference Lab discussed the results of the Industry 4.0 plan. Among the topics covered, also the relationship between automation and people.

Conference Lab Interview

“On the one hand, we are introducing new machinery in compliance with 4.0 industry aimed at collecting data and using data analysis to improve production and efficiency. On the other hand, Fedegari is reconverting the plant, which is a historic factory since our company has 60 years of tradition. For this reason it is important to deal with targeted retrofitting, so that the integration of the new machines within the plant operations can be done at 360 degrees”, explained Gonnella.

Does investing in new machinery and automation mean reducing jobs?

‘Clearly, companies must commit themselves to progressively eliminate all those tasks that are unsustainable when considering the quality of staff working life. On the other hand, it is necessary to face a requalification of personnel, where activities of low added value could very easily be replaced by automation phenomena. Personnel, if properly trained, can certainly find space within the company’, concludes the manager.

Revamp your old Quality Control equipment

Your old machinery can be upgraded with the latest generation technology to increase machine life and achieve higher performance in terms of productivity, include remote access & increase autonomy of maintenance; all of this with no downtime?  

Bonfiglioli Engineering, the worldwide leader in quality control solutions, continuously supports its clients to update their equipment with the most advanced solutions available in the field: UPGRADE III.

UPGRADE III is the substitution of all obsolete or phased out parts of the machine, for both hardware & software, with new latest generation material that is readily available in the market, including microprocessor, PLC, UPGRADE III Invertor and electrical board.

UPGRADE III offers many new features designed to improve functionality, accessibility, and reporting. Here are the reasons why you should upgrade your machinery: 

LONGER MACHINE LIFE 

REDUCED COSTS 

NO DOWNTIME 

AUTONOMY IN MAINTENANCE 

REMOTE ACCESS 

INDUSTRY 4.0 SYSTEM COMPLIANCY 

Customized maintenance contracts complete with worldwide dedicated technical services are also available to meet the specific customer’s requirements.  

Discover the solution most suitable for you! 

Contact us to receive your personal quotation:

Call 800-829-5741

Or email our product specialists

LF of America – Packaging Machine Manufacturers

Depending on your product or the size of your operation, incorporating automatic packaging machines in-house can present numerous benefits. Packaging machine manufacturers provide this such opportunity to business owners looking to take full control of their production.

There are, however, a number of packaging machine manufacturers that produce and supply packaging equipment intended for a diverse variety of industries. In order to get the most from your investment, it’s best to learn some information about what sets different packaging machines apart.

Packaging Machine Types

Packaging machine types vary depending on the type of materials you are handling. You will need to find packaging machine manufacturers that offer the type of equipment capable of managing your product consistency (liquids, solids, gels, powders, etc.) as well as the containers themselves.

The different types of packaging equipment options also include sub-categories, such as bottle equipment, automatic capping machines, and labeling machines. In addition, there are packaging machines for plastic containers, pharmaceutical packaging machinery, blister packaging, unit dose packaging, and many other options.

Automatic Packaging Machines For Liquids

LF of America specializes in providing innovative contract packaging solutions for a growing variety of different purposes. We are proud to be leaders among packaging machine manufacturers in the USA.

Our available packaging machine units are capable of everything from small to medium batches to full-size production. They offer companies with items such as cosmetics, OTC pharmaceuticals, diagnostic products, CBD oils, or even veterinary and animal care medications the opportunity to gain full independence over their production.

Shown below, our Pentafill A25 fills up to 25 vials per minute for containers ranging in size from 0.33 – 1 ml. For packaging plastic containers ranging in size from 2 – 10 ml, it is capable of filling as many as 23 vials per minute.

Our Bellow Bottle Machine units are automatic capping and filling machines also capable of various production levels. They are designed to handle filling liquids, gels, creams, serums, and powder. Altogether, these units can cap and fill up to 25 containers per minute. Learn more about the Bellow Bottle Machine in the video posted below.

Many savvy business owners and production managers are beginning to understand the overall value of investing in their own packing equipment. Packaging machine manufacturers like ourselves make that possibility a reality.

If you would like to know more about any of our units or are interested in learning the cost of purchasing your own packaging machine, contact us today 800-829-5741.

Testing the Seal Integrity of Pouches and Eye Drop Bottles

It has been determined that release torque testing is not an appropriate way to test the seal integrity (tightness) of pouch caps or eye drop bottles. The problem with release torque testing is that these caps have integrated tamper evident bands and the tamper evident bridge break torque cannot be reliably and easily distinguished from the thread break torque of the cap.

Due to this design, there is a major concern with using the release torque as an indication of seal integrity. It can be difficult to differentiate between the thread break and the bridge break peaks. Also, it is possible to rotate the cap on the bottle neck to a point where the TEB is properly engaged but the threads are not tight, and the bottle is not sealed.

If the TEB break torque of a loose cap falls in the acceptable removal torque range of a normal cap, it is impossible to differentiate between the release torque result of a tight cap and the TEB bridge break torque of a loose cap.

To overcome this issue, Mesa has implemented a new test method, one that tightens the closure and measures the rotation of the cap from the cycle start until the application setpoint is measured, instead of measuring removal. The more the cap is rotating, the looser the cap.

Using the Torqo 1600, you may use the “close measure mode” to replace the release torque test for seal integrity testing. The close measure mode is designed to measure the torque which is applied to a cap.

The system will rotate the cap in the clockwise (closing) direction until the cap begins to rotate. The point at which the cap begins to rotate will be considered the application torque and will be displayed on the screen.

Another cool aspect of the newest generation of Mesa’s Torque testers is the interchangeable tooling, that allows the end user to perform torque tests on multiple different types of packaging.

If you want to discuss your torque requirements and needs give us a call at 800-829-5741 and our project specialists will be happy to assist.

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