FVA/A1 – VERTICAL LAB STERILIZER

The FVA/A1 Vertical Lab Sterilizer combines design with Excellent performances and simplicity of use.

The automatic vertical sterilizer FVA/A1 has been specifically designed and developed to meet the most demanding application requirements in many different sectors, from universities to quality control laboratories in pharma, food or cosmetics industrial sectors.

FVA/A1 autoclave is the perfect solution for highly specialized fields and challenging customers worldwide that demand exclusive, reproducible and validated processes. These sterilizers have been designed with ergonomic features for easy handling and daily use.

The basic version of FVA/A1 can be used for standard processes and is easy to configure, thanks to its conceptual design and modular construction with exclusive optional kits. Please, click on the link “recommended kit” to check out all possible configurations referred to FVA/A1 series.

DESIGN & TECHNICAL FEATURES

FVA/A1 autoclaves are available with three different chamber volumes: 75 liters (FVA2/A1), 140 liters (FVA3/A1) and 188 liters (FVA3/A1 Plus).

FVA/A1 lab sterilizers are equipped with AISI 316L stainless steel chamber and lid with automatic independent operation and control. The access to the technical area is assured by a wide front door with a special safety lock for easy maintenance.

The exclusive horizontal swiveling lid has a patented seal with a compressed air system for perfect airtight, safety and easy maintenance.

An internal heat exchanger, made of AISI 316L stainless steel and a fan for the rapid cooling system can be integrated in the lid. An internal heat exchanger, made of AISI 316L stainless steel and a fan for rapid cooling system can be integrated in the lid. The DCS Plus 10 process controller allows fully programmability: 30 cycles easy to customize in a multi-user environment and an interface for remote monitoring via Ethernet protocol.

The DCS Plus 10 process controller allows fully programmability: 30 cycles easy to customize in a multi-user environment and an interface for remote monitoring via Ethernet protocol. The operating software is fully validated and documented.

KEY BENEFITS

  • Satisfies the most rigid requirements of safety and quality according to international standards.
  • New materials providing chemical inert insulation and both thermal and acoustic: smoother, quieter and safer operations.
  • Energy-saving system.
  • Functional and attractive design.
  • High level of programming and control versatility.
  • Innovative and unique modular design.
  • Ideal positioning of operator panel and printer.
  • Optimized loading height from floor.

Want to know more about our sterilizer product selection, please give us a call and we’ll schedule an introductory conference.

FOW – SUPERHEATED WATER STERILIZER

FOW water cascade sterilizers are able to perform counterpressure sterilization through superheated water.

In compliance with cGMP and FDA standards for LVP products, FOW autoclaves are suitable for treating loads in containers that may be deformed due to the difference in pressure between the chamber and the container itself.

Where the product is liable to separation or for accelerating thermal transition phases, the whole load can be rotated during the entire sterilization process.

  • Process optimization: The process is faster than the air-steam sterilization process. FOW is also an ideal sterilizer for <105 °C processing.

Wet loads can be overcome using an automated drying extension with the installation of specific drying solutions downstream of the sterilization chamber.

  • Easy validation & integrationThema4 process controller is pre-validated according to GAMP5 and in compliance with 21 CFR Part 11, thus resulting in shortest qualification time and minimizing project risks. An open system architecture that can be integrated with SCADA system and other Fedegari machines.
  • Highest productivity: Fedegari R&D laboratory is available to develop the best treatment solution for your specific needs. We run tests with different loads and requirements.

TECHNICAL FEATURES

  • FOW superheated water sterilizer is equipped with AISI 316Ti (AISI 316L upon request) stainless steel chamber.
  • Besides the standard versions from 830 to 14.800 liters, the loading capacity is fully customizable according to customer needs.
  • Chamber internal surface electropolished with a roughness Ra <0,4 μm.
  • One or two doors with vertical or hinged opening systems to cope with available space in the smartest possible way.
  • 5 RTD PT100 probes for temperature control (2 fixed – in the filter and discharge – and 3 flexible for the load).
  • Automatic sterilization of the air filter with a fixed RTD PT100 temperature probe.
  • 2 validation ports.
  • Fedegari exclusive patented door gaskets assure 100% tightness.
  • Piping and valves in AISI 316L stainless steel.

APPLICATION FIELDS

  • Sterilization of parenteral solutions, liquids in sealed containers not deformable (eg. glass vials) and liquids in heat-sensitive sealed containers (eg. plastic bags or bottles).
  • Terminal sterilization of prefilled syringes (PFS).

SPECIAL APPLICATIONS

ROTATING LOAD

The load is held in rotation thanks to a special rotating drum inside the chamber. The rotation drum has a magnetic coupling and is adjustable in speed, the direction of rotation and intermittently. This system finds application in the treatment of suspensions and emulsions and ensures better performance of the tightness tests for ampoules under vacuum and more homogeneous heat transmission in the load.

VIDEO

COMPLIANT TO

  • ISO Standard: 9001:2015, 13485:2016
  • European directives: 2014/68/EU – Pressure Equipment Device (PED), 2006/42/EC – Safety of machinery, 2014/30/EU – Electromagnetic compatibility, 2014/35/EU – Low-voltage device, 2007/47/EC – Medical device
  • European standard: EN ISO 12100, EN ISO 13857, EN ISO 13849-1 EN 55001, EN 61000-4-2, EN 61000-4-4, EN 61000-6-2, EN 61000-6-4, EN 60204-1
  • ASME: Stamp R, Stamp S, Stamp U
  • FDA
  • GMP

Want to know more about our certifications? Please visit the dedicated section or do not hesitate to contact us.

Filling and Packaging Line for Flavoring

Recently, Cozzoli was approached by this customer who was looking to fill gallon-sized containers of liquid flavoring. This was to be a complete line that would incorporate filling, capping, labeling and case packing. Because of the high alcohol content of what was being filled, the filling and capping sections needed to also be explosion-proof.

With the required speed of 20 containers per minute and the containers being clear, it was decided that a 10-head In-Line Fill-To-Level and our Versacapper were the best machines for this application. By using a fill-to-level machine, the liquid in each container would appear to be visually identical. If a volumetric filler was used instead, the volume of each container would be accurate, but due to slight variations in the containers, the visual levels of the liquid could appear higher or lower.

After being capped, the containers would then be moved to another room, via conveyor, where they will be labeled and eventually packed into boxes.

For the labeling and case packing sections of this line, we reached out to our partners at ID Technology and EpsonThe challenge for these areas was that the customer wanted the labels to be print-on-demand. Rather than having the labels feed off of a role, which is the typical application, they needed to be fed directly from the printer to the labeler.

The biggest challenge of integrating the printer with the labeler is that the printer backs up about 12” every time it begins to print. To combat this issue, we used a loose-loop system that uses sensors to monitor the status of the printer and labels.

3 sensors were added into the loose-loop system. The lowest sensor monitors the loose loop to stop the printer when enough labels have been printed.  The middle sensor tells the printer to produce more labels.  The top sensor signals out-of-labels and stops the applicator until more are available. By using this loose-loop system we successfully integrated the printer with the labeler.

Finally, after labeling, the containers are then moved to a table where they are manually packed into boxes and fed through a case packer, which automatically closes, tapes and applies a label to the box.

For more information on how we can help with your complete filling line applications, contact our offices at 800-829-5741

Still time to Revamp Your old Bonfiglioli Engineering Machine

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: 800-829-5741

Solutions for Contract Packaging and Filling Companies

Contract packaging companies provide many businesses with the resources they need to succeed. Being able to deliver high-quality products in reliable packaging that is as practical as it is cost-effective is one of the greatest advantages setting many pharmaceutical, cosmetics, and familiar businesses apart from their competition.

What makes LF of America among the top contract packaging companies in the USA is our commitment to each of our prospective clients. Using state-of-the-art contract packaging and filling equipment along with an exceptionally high standard of quality, our clients can trust that we handle every one of the products we handle with the same level of care we would if it were our own.

If you’re looking for contract packaging and filling companies that you can depend on for ongoing reliability, here’s how LF of America can help.

Contract Packaging Services

Our available contract packaging options extend far beyond the unique containers we manufacture. The diverse variety of innovative packaging options we carry enables clients to make the most of the products they provide. In addition, it helps businesses show their customers that they care just as much about the consumer’s use of the products as they do about the products themselves.

We manufacture different packaging options that include unit dose packaging, wand tubes, bottles with droppers, dual chamber bottles, enema containers, vaginal containers, and the specially designed Bellows Bottles. Each of these is available in different options to ensure they are suitable for the unique applications associated with every product they contain. We also provide custom packaging manufacturing services to further meet the more specialized needs of specific clients.

Contract Filling Services

Our in-house contract filling services are a cost-effective option for companies within the pharmaceutical, cosmetics, veterinary care, diagnostics, and familiar industries. We are capable of safely filling liquids in most liquid viscosities, including liquids, gels, creams, and even powders.

Moreover, as turnkey contract packaging partners, we are able to fulfill production demands from start to finish. Our turnkey services are from formulation to batching, packaging selection, and filling, all delivered by one convenient source. We even carry contract filling machines for sale that give our clients the chance to introduce their very own in-house filling solution.

End Your Search For Contract Packaging Companies

If you’re searching for contract packaging companies and are unsure which choice is the best option, we can help. LF of America is proud to be the US-based member of the Lameplast Group, a worldwide leader in contract packaging.

We perform all our contract packaging and filling services in-house and utilize an ISO-8 cleanroom to guarantee safety and quality control. Contact us to get a free quote for any of our contract packaging and filling services or to learn more about what makes us your perfect packaging partners call 800-829-5741.

ST-120S Industrial Cap Torque Tester

The ST-120S features a servo drive control, infinite chuck rotation, quick-change tooling, a color touchscreen interface, and faster cycle times.

The corrosion-resistant stainless steel head enclosure and anodized aluminum frame construction make the ST-120S ideally suited for the most demanding applications, such as testing closure torque at Carbonated Soda Drink (CSD), juice, bleach bottling operations as well as cleanroom environments.

The unit is equipped with anti-bridging, anti-tie down anti-repeat dual actuation safety start switches, but for maximum operator safety, the ST-120S can be also equipped with a full machine guard.

Features

  • Real-time, automatic display
  • NIST traceable calibration procedure
  • Strain gauge transducer technology
  • Automatic container clamping and closure gripping
  • Adjustable torque application speed
  • Counterbalance system for height adjustment
  • Infinite rotation (SERVO)
  • Encoder to measure the angular degree of rotation
  • Heavy-duty components

Testing Capabilities

  • Applied Torque: The ST-120 can be used as a benchtop capper, tightening the cap to a customer-defined setpoint.
  • Release Torque: The ST-120 is designed to accurately measure the release (thread break) torque of a cap.
  • Peak/Transient Torque: The standard ST-120 can measure and display the Applied or Release Peak in a torque testing cycle, however with optional hardware upgrades it is also possible to measure certain torque transients such as the engagement torque of a CR closure system or the peak of the bridge break torque of a Tamper Evident Band.
  • Container/Closure Fatigue: By allowing the ST-120 to apply and release the cap a number of times, it is possible to evaluate the effect of fatigue on the torque retention and seal quality of the closure and seal.
  • Release and Re-apply Torque: When packaging expensive products it is often required to return the tested container to the packaging line. By automatically re-applying the torque to the operator defined setpoint it is possible to save the product.
  • Topload Force (optional): This feature allows the monitoring and control of topload force. When testing child resistant caps or other closures requiring topload adjustment this feature allows the evaluation of topload force in the function of rotation and torque.

Contact Life Scientific, Inc. for more information on this equipment.

How does Vetromeccanica’s Vacuum Conveying Work?

Vacuum Conveying is the process of moving bulk dry materials, such as powders, from place to place within a factory using suction. The material is transferred in a network of tubing from the pickup point or source to the customers’ process. Most Vacuum Conveying System transfer product based on a timed interval to the vacuum receiver. At the end of the timed sequence, the discharge valve can open and the material conveyed can discharge into the process. 

There are two types of vacuum conveying. Dilute phase conveying and Dense phase conveying. 

  • Dilute Phase Conveying the material is entrained in the air stream and the is an almost equal part of air and product. This method is excellent for conveying almost any type of powder-like sugar or flour. 
  • Dense Phase Vacuum Conveying the material is transferred in slugs within the convey tubing. The material moves slower then dilute phase conveying and is an excellent choice for a friable product or a blend of powders. 

Vetrommecanica’s conveying systems differ from others because they increase the real plant efficiency. They are a major player in more than 70 Countries thanks to the care and attentiveness to details, capability to offer a 360° all-rounded service, and to their extremely skilled customer-care department.

Learn more about the conveyance solutions we are currently offering by giving us a call at 800-829-5741

Onion Skin Ampoule Filling and Sealing

A manufacturer of drug and explosive detection equipment for law enforcement, hazmat teams and educational systems.

Cozzoli were approached about a need for filling onion skin style ampoules. These ampoules would be part of a mobile detection system, where after swabbing a potentially contaminated area, the swab is inserted into the pouch and the ampoules are crushed. The chemical inside of the ampoule mixes with the swab and will detect if any drug or explosive residue is present.

This application would require the ampoule to be filled with a small and very precise amount of liquid, then flame sealed.

This was a perfect application for our FPS series ampoule filling and sealing MonoBlock. The application required the filling of 6.70mm x 60mm onion skin tubes with .10 mL -.40 mL of liquid. This would have to be done at a production rate of 45 -50 ampoules per minute. Due to these requirements, the FPS1-OS-SS was chosen for the job.

Our FPS series monoblock fills and seals a variety of ampoule shapes and sizes, at speeds of 15-120 ampoules per minute and a fill accuracy of +/- .5%.

With the fill volume requirements being so small, a peristaltic pump was added in order to feed the liquid into the machine. A peristaltic pump is typically used for very precise filling applications, as well as applications where the liquid is clean/sterile and cannot come into contact with any exposed pump components.

For more information on how we can help with your ampoule filling applications, contact us at 800-829-5741

Fedegari: Advancing aseptic processing

While pharma has made tremendous strides in aseptic processing, the industry still struggles with contamination issues — indicating there is more work to be done. Like all segments of the pharma industry, aseptic manufacturing continues to be transformed by disruptive technologies. With the goals of maintaining compliance, lowering costs, and streamlining processes always at the top of mind for drugmakers, industry vendors are innovating solutions that incorporate the latest trends and capabilities.

“Firms are striving to reduce costs and improve process flexibility, while fundamentally eliminating some of the potential contamination challenges,” says Ben Wylie, senior product manager at ChargePoint Technology.

Pharma may be close to mastering aseptic manufacturing, but innovative tweaks and updates to equipment and operations are helping improve the process even more.

Robots have been a game-changer in the packaging department of facilities, and are now transforming the filling process as well.

“Robotics are progressively more available in aseptic processing due to the flexibility they allow — saving time for the operator who would otherwise need to change parts to fill very different kind of vials, syringes and cartridges,” says Federico Fumagalli, chief commercial officer at Steriline. “With robotics machines, they just have to change a single parameter on the robot to change the whole production process.”

Steriline’s Robotic Vial Filling Machine was designed specifically to address the industry’s growing need for flexibility. According to the company, the machine can be equipped with one or two Stäubli vaporized H2O2 resistant anthropomorphic robotic arms (depending on output requirements), which transport the vials within the machine.

Although Fumagalli says there are pros and cons to using robotics, a cost-benefit analysis favors robots because they can reduce downtime, prevent product loss and decrease waste.

“In case a vial is not correctly stoppered, the robot can repeat the stoppering cycle to complete the process,” he says. “On a traditional machine the vial would be rejected — the content discarded — losing a potential earning, and the company would have to dispose of the waste, incurring further costs. Using a robotic system, the vial could go backwards and be stoppered during a second cycle, without any waste.”

Fedegari Technologies has also been developing ways to combo advanced solutions, including robotics, into one piece of machinery.

“The manufacturing processes of the future will streamline new technologies like robotics, artificial intelligence and IoT, into an increasingly closed and connected production process,” says Jeffrey Siterlet, managing director of Fedegari Technologies in North America. “By linking components, isolating the process and centralizing control, tomorrow’s manufacturing process will facilitate efficiency, safety and compliance while eliminating risk.”

The company’s new washer sterilizer, for example, offers sterilization, washing and bio-decontamination in one solution. The gloveless sealed isolator hosts a GMP robotic arm that can be adapted for different batch sizes and simplifies cleaning requirements needed to enter a controlled-contamination environment.

Single-use solutions continue to play a dominating role in pharma manufacturing innovations and provide a wide variety of benefits.

“As single-use and disposable products become more widely utilized, the manufacturing process becomes more efficient through quicker changeovers and set-up times and drug manufacturers can react more rapidly to product and customer demands,” says Wylie.

ChargePoint recently added two products to its single-use portfolio including the ChargePoint Single Use Passive (SUP) and ChargeBag PE-S with new HiPure ULP7 PE film. Together, the two products are intended to form a high performance, single-use package for the contained and sterile transfer of powders between manufacturing process steps or even facilities.

The company says that the ChargePoint SUP is a disposable version of the passive mating half of the ChargePoint SBV (Split Butterfly Valve) technology, which forms a complete hybrid system to ensure users can take advantage of the benefits of disposable technology.

“Technologies such as SBVs are increasingly replacing traditional open transfer techniques, enabling contained and efficient materials transfers,” Wylie says.

Importantly, single-use innovations are also happening for the final stage of the manufacturing process: Transport.

“As the trend of biologics being manufactured in one location and going through the final fill process in another grows, the need for materials that can withstand manipulation at temperatures down to -86 degrees C continues to accelerate,” says Alex Kakad, product marketing manager for AdvantaPure.

AdvantaSil Ultra Low Temperature Silicone Tubing is designed to remain flexible (as opposed to cracking and leaking fluids) at temperatures as low as -112°C. According to the company, its tubing and molded closure assemblies have glass transition temperatures below -100 °C, allowing for a comfortable safety factor for these demanding applications. This, AdvantaPure says, makes the tubing an optimal choice for applications related to bulk drug storage and transport.

From the first stages of aseptic processing until products exit the factory doors, technology trends are continuing to transform sterile pharma operations.

For further information on products that incorporate this technology please contact our corporate offices and/or sales representatives.

The Newman S250 Labelling Machine

The Newman S250 Labelling Machine is a fully automatic, versatile self adhesive labelling system for the application of paper and clear labels to cylindrical, rectangular or square containers in glass, plastic, metal or composite materials.

The S250 has been specifically designed to meet the requirements of the international pharmaceutical industry and its regulatory bodies, including the FDA, but is equally suited to other industries where flexibility, high speed, accuracy and reliability are pre-requisites. 

A variable speed roller at the infeed spaces the containers entering the machine. Each individual container is detected at the labelling point as it passes a sensor, at which point the label feed is activated. The leading edge of the label is driven off the backing web at a linear speed that matches the container speed; this ensures smooth, accurate placement on the container surface. The container, gripped between an applicator drum and presser pad, is controlled as the label is pressed firmly in place, ensuring high registration accuracy.

Features

  • Compact cGMP Design
  • ‘Auto-teach’ label length facility
  • Digital scales for rapid container changeover
  • Positive accept security system
  • Fully validated security system with Critical Device Checking
  • Minimal change parts
  • High performance stepper motor for label web drive
  • In Process Control – system verification without production stoppages
  • Accurate label placement
  • Stainless steel 304 finish
  • Siemens orAllen Bradley PLC control system
  • Hot foil coding unit
  • Validation documentation and implementation package
  • Auto-reject system for both incorrect label data and missing label detection with reject verification
  • Touch screen HMI with run mode and set up mode (key switch access) facility
  • Counter package with full count reconciliation
  • Secondary presser unit – labels over 110mm or square / rectangular container applications
  • End of web detection
  • Container feed by gating rollers or optional feed scroll

Options

  • Belt applicator system for higher speed option, up to 300 cpm
  • Printout facility
  • Continuous label supply via the Easisplice 470 unit
  • Queue switch control
  • Vision Systems for OCV / OCR / barcode
  • Rotary infeed & outfeed tables
  • Thermal transfer, laser and inkjet printing
  • Left and Right hand option available

Contact us for more information on product specification and pricing!

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