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.

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.

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.

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.

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.

Table top Container Closure Integrity Tester

The LF-S11 by Bonfiglioli is a countertop compact machine, designed for Non-Invasive, Non-Destructive Container Closure Integrity Testing of diverse types of Pharmaceutical Containers filled with liquid, lyo, powders, etc..

Suitable for In-Process Control and Laboratory use without altering container and/or content features.

The integrated software system allows full compliance to provisions stated in FDA 21 CFR part 11 as well as EMA Annex 11.

3 Configurations of the machine available to meet all specific requirements:

– BASIC, for most of the container formats 

– XL, designed specifically for large formats (more than 100ml)

– SY, designed for syringes, carpoules including automatic plunger stopping device

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”

All dedicated test chambers are designed according to the container characteristics for a maximum of leak detection sensitivity and are monitored by specially developed electronics during the testing process. The group has been recently redesigned to obtain improved functionality (quick

 single-handed opening and closing). It is directly installed onto the Testing Chamber supporting flange and it is composed by: – A fixed bottom part; – A removable top cap (upper part) that allows plugging up the testing group corresponding to Container loading and unloading operations.

HOW IT WORKS

The test chamber fixed bottom part is equipped with a mobile piston, plunger stopping device (PSD), having vertical motion between two limit positions, “upper” and “lower”, and having a section equal to that of the PFS plunger.

The initial vacuum, generated in the test chamber, produces an upward movement of the PSD.

The same “upper” position is kept until the second reading; at that time, the action of a dedicated pneumatic actuator provides for exhaust of vacuum in the test chamber bottom area and produces the PSD downward movement towards the “lower” position.

For more information, please call our office and we’ll be happy to assist.

Lunch and Learn webinar series

If you want to learn more information about the equipment and machinery that is manufactured by the companies we represent, To meet the team of engineers behind the projects and hear their thoughts and opinions on some of the critical processes that they were challenged with, then the Lunch and Learn Webinar Series will be a good place to start.

You’ll also have the opportunity to learn about the key features of specific products and equipment and what is their proper application.

Among the most viewed topics we discussed on our webinar were:

  • The never ending debate of Injection Molded Unit dose delivery systems versus the Blow Fill Seal containers;
  • The discussion of proper storage methods, Standalone Freezers or Consolidated chambers;
  • The presentation on the Key Factors of the development of a Cleaning Strategy;
  • The often overlooked issues with quality control equipment and solutions;
  • A nice presentation of the applicability of Torque testers on the Pharma Market;
  • The important part that conveyance plays in your production efficiency;
  • and you can find a lot of case studies and machine demos in each episode of the Lunch and Learn Webinar Series.

Our Webinar Broadcasts are always public, free to attend and comment. In order to receive updates about any upcoming streams of our Webinar you can Subscribe to our Website, Connect with our LinkedIn Page, or Subscribe to our YouTube Channel.

If you have any special Requests about some topic being discussed on the series, have questions about any previous streams or you’d like to inquire more information about any aspect of the series, please send an email to Marko via MarkoV@Lsi1.com

Merry Christmas and Happy Holidays

As the holiday season is upon us, we find ourselves reflecting on the past year and those who have helped to shape our business. It’s been quite a year for us all!
We hope that 2019 has been just as memorable for you, your colleagues and your loved ones. We look forward to working with you in the years to come.

Seasons Greetings. May your holidays be merry and bright.

Let us take this opportunity to thank you for all your faith and dedication towards our company, on this Christmas.

Hope your bond lasts forever.

Merry Christmas!

Cosmetic Filling And Packaging

LF of America provides cosmetic filling and packaging services for a variety of liquids, creams, lotions, serums, and powders. Our cosmetic contract filling services are done using state-of-the-art liquid filling machines that are can be used for small batch orders all the way up to large-scale production sizes.

We also provide a wide variety of different cosmetic packaging options that will perfectly accommodate your product so that it is safe for distribution and appealing to consumers. The cosmetic packaging options we provide include everything from unit-dose packaging for easy, precise delivery to dual chamber bottles with tamper evident caps, and more.

Find out more about what is all included in our cosmetic filling and packaging services below. To get started today, contact LF of America and let us prove to you why we are the best turnkey partners in the cosmetic filling and packaging industry.

 

LF of America is proud to say that contract filling for cosmetics is one of our primary specialties. We take great pride in our impressive ability to fill and seal cosmetic products in accordance with the best industry practices for assured product safety and quality.

The process is performed on-site in our state of the art facility, which houses advanced liquid filling machines in completely controlled areas. Our ISO-8 cleanroom is in accordance with all Cosmetic GMP regulatory guidelines, extending from the Quality System Requirements for medical devices.

The filling machines for cosmetic liquids and creams can handle most liquid viscosities and the line speeds can work at different rates, meaning no order is too big or small or us to handle. In addition, we are capable of filling your own packaging design or you can choose one of our cosmetic packaging options.

These packaging options include unit-dose packaging for cosmetics, wand tubes with hypoallergenic applicators, dual chamber bottles, bottle with droppers, enema containers, containers for vaginal use, and the diversely unique Bellow Bottles complete with various applicators and different size cannulas.

Turnkey Cosmetic Filling And Packaging Services

Our cosmetic filling and packaging services are truly all-inclusive and include everything from formulation, batching, packaging selection, and filling. We also offer packaging manufacturing and provide custom packaging options where we will hot stamp, emboss, and label, and pad print your product before distribution.

It is our mission to guarantee satisfaction for our customers and our shared goal is to help our clients succeed in their venture, however big or small. Whether your need is to test out a new line or prepare a best selling product to meet consumer demand, our cosmetic filling and packaging services can help you get it done quickly and affordably.

Give us a call to ask us more about the premier choice in contract filling at 800-829-5741 to get started today.

 

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