Fedegari Eco Steam Washers

FSW Eco-Steam Washer is the latest industrial innovation of Fedegari Group addressing pharma, food and cosmetic industries. FSW Eco-Steam Washer innovates the concept of GMP washing thanks to the use of steam in the washing cycle. Fedegari has decades of experience in steam technology. Due to this fact, FSW Eco-Steam Washer has been designed in an original way, if compared to traditional industrial washing machines.

Steam works as cleaning agent and water heating. The direct injection of steam into the washer chamber avoids the need for additional heating elements and results in a cleaner in-chamber environment. In case of need, FSW Eco-Steam Washer can be equipped with a steam generator.

Due to its emollient effect on greasy and sticky dirt, the steam reduces the use of detergents and improves chamber and load sanification. During the washing cycle, the injection of clean compressed air filtered by the Pall vent filter (0.22 µm) increases the mechanical action of washing/rinsing through the chamber.

Final drying is performed with hot air filtered by Hepa filter H14 injected in chamber, in order to assure the total drying of the machine and of the load.

DESIGN AND TECHNICAL FEAUTURES

  • Chamber and hydraulic components made of AISI 316L stainless steel with sanitary finishing
  • The door (hinged or sliding) is made of glass with the perimeter reinforcement made of AISI316L stainless steel
  • Fully modular and customizable internal trolley: it can be designed according to the customer’s load
  • Internal trolleys are designed to avoid any water stagnation thanks to dedicated draining points
  • Thema4 process controller ensures a total control on washing performance, therefore a robust reliability during inspection and validation activities
  • In case of emergency, alarms are audible and visible: an internal LED lamp is operative during the whole cycle and its alarms operates through LED color change.

KEY BENEFITS

  • The power of steam: emollient effect and sanification agent
  • Eco-solution: less detergents, less energy and water consumption
  • High customization of washing process
  • Custom-made internal trolleys
  • Process monitoring system

To learn more about the Fedegari FSW Steam Washer and its capabilities get in touch with our head office and speak with our project engineers 800-829-5741.

Save On Cozzoli Parts This Summer

It’s that time of year again! To celebrate we are offering a Summer Parts Special to get your Cozzoli and MRM/Elgin machines running in peak condition!

  • 10% discount on parts for your summer shutdown
  • Discounts on preventive maintenance
  • Consultation service call comped when recommended action taken*

Our Customer Service Department can schedule performance evaluations and get you the best deal on commonly used machine parts.

  • Preventative maintenance with one time evaluation or regular scheduled inspections
  • Restorative maintenance including improvements, upgrades, wear part replacement, and parts repair or re-conditioning
  • Operational & maintenance training for new employees and refresher courses for experienced technicians

*Some restrictions may apply

CONTACT US TODAY!

Give us a call at 800-829-5741

BONFIGLIOLI ENGINEERING moved at its new headquarters

From 11th February 2019, Bonfiglioli Engineering is fully operative from its new headquarters at Via Vespucci 20, Ferrara, Italy.

We are all set to enlarge our premises, moving to a newer and bigger location with a total area of 11.000 square meters, hosting a staff of over 90 employees.

The production area which has been designed in collaboration with Specialized Consultants, is based on the principles of Lean Manufacturing, to greatly improve production efficiencies, eliminate wastes and reduce costs.

A value stream mapping has been done for the production area that has a sizable capacity (4.000 square meters, capable of assembling 20 rotative machines simultaneously), to create flow & structure that will even help to reduce time to market.

The most advanced of approaches has been used to modernize & restructure the building in terms eco-sustainability, heating systems with zero methane consumption and use of solar panels.

Special focus has been laid on wellness, health and safety of all employees with an office area (2.000 square meters).

The new site also boasts of a large warehouse and an exclusive showroom, displaying machinery and containers, dedicated to clients.

This move comes with the objective of upgrading size and optimizing production to meet the ever-growing demands of client partners.

2019 will certainly be a year to remember for Bonfiglioli Engineering!

Why to Invest in a Liquid Filling Machine

Many times companies depend on contract filling services to fulfill their packaging needs. Contract packaging and filling companies like ourselves give clients the opportunity to have all of their requirements completed under one roof. However, over time, production needs can change, motivating businesses to look at investing in their own filling equipment.  Owning an in-house liquid filling machine comes with various advantages, making it a prudent financial investment.

For this reason, LF of America offers companies the option to invest in their very own automatic liquid filling machine for plastic containers. Learn more about our line of filling machinery below or contact us to receive further details. If you’re still not prepared to invest in your own in-house filling machine, consider LF of America your perfect turnkey partner for all packaging and filling needs.

How Our Liquid Filling Machine Works

Safe packaging is a necessity for all companies within the pharmaceutical, health and beauty cosmetics, veterinary medicine, and diagnostic industries. Product safety is of paramount importance and requires logistical planning throughout every phase of the production process, including filling and sealing.

Our available contract filling equipment for sale exceeds all the safety standards while delivering truly reliable results. The Pentafill Machines utilize blow, fill, and seal technology in combination with injection molding. The advantages of using blow, fill, and seal with injection molding are increasing safety throughout the process.

Rather than risk contact between product and heat by combining the blow and fill process, a potential danger which could damage the product, our liquid filling machine fills the containers first. Next, the containers are moved along for a separate heat blow process, ensuring no contact to the product. Then, the heat seal #1 and #2 take place. Finally, cold crimping completes the filling before unloading the containers to pick up.

To learn more about our liquid filling machinery, contact our corporate HQ via 800-829-5741

Torque Testers in the Chemical Industry

Many chemical products are sold in spray bottles which must withstand corrosive chemicals. These bottles often use a trigger handle for dispersion, which can produce interesting torque challenges. The unique combinations of bottle and cap in the chemical industry may consist of push and turn, dispensing, snap top, child resistant, or squeeze and turn closures.

Mesa’s universal tooling approach offers solutions for all of these combinations. Our torque testers are also built to withstand corrosive chemicals that may come in contact with the tester, and are capable and built to handle oversized, uniquely shaped bottles.

To learn more about which Mesa Torque Tester is right for your chemical products, contact our office and request to speak with some of our torque product specialists.

Challenges

Spray bottle and other unique bottle/cap combinations can make torque verification and analysis a challenging proposition for this industry, but Mesa’s universal tooling approach offers solutions for these unique situations. Our Torque testers built to withstand corrosive chemicals which may come in contact with the tester. Mesa’s testers are also capable and built to handle oversized, and uniquely shaped bottles, which are prevalent in the chemical industry.

With a highly sensitive strain gage-based torque transducer, a 2000 CPR rotary encoder and proprietary pressure controlled cap and bottle gripper designs, our servo-driven automated torque tester can accurately detect both small and large changes in the torque and angle during the removal of a closure.

When tamper evident caps are used just knowing the release torque is not always enough, often knowing the torque required to break the bands is desired. Using a rotation driven release both the thread break and the band break can be measured. (See pg. 45 of ST-120S operator manual for info on how to set this up).

With the ability to deliver and measure up to 88 lbf.in (10 Nm) of torque, we can find and report the torque it takes to strip out the threads when tightening your containers closure.

Used to tighten a cap to a precise torque. Not often used by itself, aside from an evaluation or validation of a capping process, it can also be combined with the release testing for nondestructive testing as well as fatigue and accelerated aging testing.

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.

FEDEGARI PRESENTS ADVANCED PHARMA TECHNOLOGIES

Fedegari Group demonstrated a working, prototypical pharma sterilization production line at Interphex, Booth 3461 at the Javits Center in New York, USA.

Jeffrey Siterlet, Managing Director of Fedegari Technologies announced that the company will exhibit its state-of-the-art sterilization, washing and decontamination technology at the upcoming Interphex show, booth 3461.  The highlight of the display will be Fedegari’s innovative multi-process system, simulating an operational pharma production process.  It will demonstrate the integration of a number of processes, including sterilization, washing, chemical bio-decontamination, robotic handling and others, in order to speed production, reduce footprint while eliminating contamination risk.

Operation of the system is coordinated utilizing the one of the fastest and most flexible process controllers in the industry, the Thema4, also designed and produced by Fedegari Group, a global leader and pioneer in sterilization, washing, and bio-decontamination technology for over 65 years. Because Fedegari’s controller technology is proprietary and is based in VxWorks, it is also 100% immune to hacking and tampering.

Said Siterlet, “The more manual steps that are in the pharma manufacturing line, the greater the risk of contamination.  The Fedegari system reflects a visionary approach to streamlining new technologies, like robotics and IoT, into the process. Our system eliminates all disconnection by completely enclosing the process and centralizing the control to provide efficiency, safety and compliance without equal.”

To enable bio/pharma customers and prospects to more easily visualize their individual processes, issues and needs, Fedegari Group recently opened its Tech Center in suburban Philadelphia. The Tech Center is designed to be an industry resource, equipped with various process components and simulators for hands-on testing and training, replicating the same activities pharma industries utilize at their own bio/pharma manufacturing plants.

Interested in getting more information about Fedegari products? Get in touch with our pharma tech project specialists at 800-829-5741.

Register for the upcoming Bonfiglioli Engineering Webinar of April 29th

Young business people forming service word over white

Register for the upcoming Bonfiglioli Engineering Webinar of April 29th

“Aftermarket Department: Making Customer Service a High Priority”.

This webinar is your guide to understand how we can assist you, what’s new in our services, where you can find us and how we can be by your side, whenever needed!

We will talk about this & much more: 

MRO SERVICES:

  • RETROFITS / UPGRADES
  • PREVENTIVE MAINTENANCE PROGRAMS
  • YOQ (YEARLY OPERATIONS QUALIFICATION)
  • ANNUAL TRAINING CONTRACTS

CUSTOMER CARE SERVICES:

  • CUSTOMER SERVICE
  • SPARE PARTS
  • CALIBRATION LEAKERS RECERTIFICATION
  • REMOTE SUPPORT

The Webinar is pre-recorded, and it will take just 12 minutes of your time, with a Q&A session right after the recording, which will be managed directly by the Customer care team.

The webinar “Aftermarket Department: Making Customer Service a High Priority” will be repeated 3 times on the 29th April (Monday).

Please feel free to select the slot most convenient to you, according to your time zone:

https://attendee.gotowebinar.com/rt/5991084226772099587

After registering, you will receive a confirmation email containing information about joining the webinar.

Cozzoli CR Series liquid filling for pharmaceuticals

Cozzoli’s Model CR200/400 provides continuous-motion filling and stoppering of liquid pharmaceuticals. Offering production speeds up to 200 and 400 containers per minute respectively, this machine performs with outstanding volumetric accuracies of +\-0.5% of fill volume, or better, with either full or partial insertion of stoppers.

FEATURES

Production and cost saving features include compact size, machine taking up less than 46 sq. ft. of floor space, quick and easy changeover, and a vibratory bowl handling stopper sizes of 13 to 20mm or 20 to 28mm. When used with laminar flow, the CR400’s open flow-through design of the central star-wheel significantly lowers particle counts to well under GMP standards for use in Class 100 cleanrooms. This microprocessor controlled machine features a stainless steel exterior with all liquid contact parts fabricated of 316 stainless steel and medical grade silicone to accommodate sterile requirements. It also provides missing container, make-up and back-up detection systems.

OPERATING PRINCIPLE

Containers enter the machine via the infeed conveyor, where they are transported single file into a Delrin timing screw where they are precisely spaced into star wheel pockets. Containers are then transferred into a larger main starwheel where the filling operation occurs. After filling, containers travel to the exit starwheel for stopper positioning and insertion. The continuous motion handling of the containers reduces machine wear, and provides for gentle handling of the containers.

STANDARD FEATURES

Syringe Assemblies Nozzle Assemblies Tygon Tubing 1 Set of Vial Change Parts Vibratory Bowl Stopper Feed Assembly Stopper Delivery Assembly Valve Assemblies Down Vial Eliminator Upstream Make Up Sensor System Downstream Back Up Sensor System Electronic Digital Rate Indicator (LED) 9′ Center to Center Conveyor Assembly 303/304 Stainless Steel Exterior Construction Microprocessor Control DC Machine Drive NEMA 4, 220V, 60Hz, 1 Ph Electrical Full Color Operator Panel Password Protected Operating Parameters

OPTIONAL FEATURES

  • Lexan Enclosure
  • Additional Change Parts
  • Additional Nozzle Sizes
  • Ethernet PLC Upgrade

Contact the Life Scientific, Inc. Project specialists for further information regarding the latest updates and quotes of the liquid filling solutions for pharmaceuticals

Vetromeccanica – Solution for all Conveyance needs

VETROMECCANICA , founded in 1992, has its Headquarters in Provazzano (Parma) the core of the Italian Packaging Industry. 

From the very beginning, it has been our passion, for delivering customized solutions tailored on the real needs of all our clients, that leaded us. 

Nowadays, this passion guides our R&D department in designing and blueprinting our system solutions and in looking for the best components and raw materials available on the World market.  

Our very specific Know-how united with our focus on our clients needs made us the professionals in delivering customized automatic conveying solutions. 

Our plants for beverage & food, chemicals, personal and health care, cosmetics sectors are specifically designed to optimize the production process and, meanwhile, reduce at the lowest possible level the energy consumption. 

Our conveying systems differs from others because they increase the real plant efficiency. 
We are a major player in more than 70 Countries thanks to our care for details, our capability to offer a 360° service, our skilled customer-care department.

Contact our office for more information and project assessments of your conveyance needs.

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