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.

PDA Conference: Learn the latest in testing innovations

Bonfiglioli Engineering, is delighted to announce its participation at PDA Europe Parenteral Packaging Conference, that will be held on March 19-20 2019 at the beautiful location of Hilton Molino Stucky in Venice, Italy.

The conference brings together industry and regulatory experts to share their experiences, new developments, regulatory considerations, trends and best practices in the field of parenteral drugs.

During the 2 days event, Bonfiglioli Engineering will welcome you at tabletop # 9 and at the  scientific poster session to discover the latest innovations in non destructive, non invasive Container Closure Integrity Testing, Visual Inspection and Headspace Gas Analysis for Laboratory and In-line pharmaceutical packaging markets solutions.

The equipment is also available for demos in the US so get in touch with our sales reps and we’ll make sure to include you in our meeting agenda.

TABLE-TECH CONVEYORS FOR CRATES AND CARTONS

Vetromeccanica is well known and widely respected for their Table Top conveyance systems. Their TableTop conveyor system offers a versatile design, which makes it a popular conveyor system suited for a wide range of high-speed production environments. Their TableTop conveyor systems are built to work almost anywhere in your production line.

Known for their quick deliver time, fast and easy install and cheap operational fees, Vetro’s Table top systems provide the biggest bang for the buck.

The flat top plates are stronger than modular belting and transport items through production more efficiently and safely.

TableTop conveyors have excellent flexibility for production line layouts, being suitable for curves or changes in elevation, thus streamlining factory operations.

The flexibility often stands out when a production line needs a versatile solution that can serve your transporting, merging, diverting or accumulation problems.

Key Features of the standard Bench Top / Table Top conveyance models:

  • Low friction values
  • High resistance to wear
  • Low noise level
  • Wide chain applications
  • Stronger chain configurations
  • Easily integrate with existing systems
  • Low Power Consumption
  • Easy To Install
  • Easy To Clean
  • Small Foot Print

Get in touch with our office now and schedule a call or a meeting help us better understand your conveyance needs, so we can estimate your project challenges up to the tiniest detail.

Torqo 1600 Non-Destructive Cap Torque Tester available in the Trade In Program

The Torqo 1600 is a durable and reliable computerized cap torque analyzer which is setting a new standard for torque measurement throughout the packaging industry. With on-board microprocessors, it makes torque testing simple, accurate and affordable.

The Torqo 1600 is easy to use, easy to set up, easy to move and low maintenance!

Tooling is available for any threaded closure – including child resistant caps – and this compact unit delivers and stores precise results at the touch of a button.

The Torque product line has been providing accurate torque measurement readings for the past 50 years. The Torqo II+ system incorporates 15 years of factory floor proven technology, supplying customers with precision torque data to help improve the production as well as the packaging of the product.

Mesa Torque systems have become the standard in the beverage and pharmaceutical industries, consistently providing accurate and reliable torque level readings to help companies manage quality control.

• Compact Size

• Constant Speed Drive

• Simple Touch Screen Programming

• Calibratable in the Field • NIST Traceable Calibration

• Wide Operating Temperature Range

• Non-destructive Testing

• Full One-year Warranty

• USB Connectivity

• Ethernet Connectivity

• External Universal Power Supply

• LAN Connectivity

• RS-232 Port

Cap torque analyzers have been serving the torque industry for many years now. Many models done a tremendous job providing consistent, reliable data and providing However, most models were designed several years ago and contain many critical components that are now obsolete and unsupported. Mesa Laboratories, Inc. is offering an upgrade option for the Torqo 1590 to 1600. Call our office today and find out more.

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.

Cozzoli Introduces Lower Parts Pricing

With the on-going trade tensions, we know that many of our customers have taken on the burden of dealing with tariffs which have increased their cost of doing business.

Cozzoli are committed to help remove some of that burden, so today we are announcing that we have dropped prices on most of our parts.

By becoming more lean in our manufacturing processes, we are now able to produce parts at a lower cost. To best take advantage of these lower costs, we want to pass along the savings to our customers.

Call us today, and request an updated quote on the interchangeable parts and tooling we are currently offering for all Cozzoli products.

Call our office 800 829 5741 and we’ll glad to be of assistance.

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