Tabletop Screw Capper for Food and Beverage applications

The Cozzoli Screw Capper Model SC50T will cap sizes up to 95mm in diameter. The adjustable torque slipclutch configuration rotates, giving uniformly tightened caps and preventing cap damage with gentle cap handling. Configured as an aluminum Sealing machine, the SC50T features a selective two-speed drive to a rotating and reciprocating spindle, with a maximum up-down stroke of 2” or 50.8mm. The Aluminum Sealer provides uniform roller-sealing of container crimp caps up to 43mm in diameter. In either configuration the SC50T is ideal for clean room lab use or small production facility.

An automatic version of this machine can be mounted on a fully integrated Cozzoli packaging line. 

Screw cap configuration: With the cap in position, the operator places the container against a “V” plate. The reciprocating spindles then automatically descends to screw on the cap. Torqueing time can be adjusted from .15 to 10 seconds, thereby accommodating most capping speeds.

Aluminum Seal Configuration: With the cap in position, the operator places the container against a “V” plate. The crimping head that consists of 3 blades and 3 rollers then automatically descends to seal the cap; Crimping time can also be adjusted from .15 seconds to 10 seconds.

For more information on this and other Food and Beverage machines, please get in touch.

More than an Autoclave – The Fedegari FOB 4

The FOB4 Stand-alone Lab Sterilizer is an autoclave that combines excellent performances with overall high quality materials and ease of use.

The FOB4 Lab Sterilizer is suitable for the use in laboratory conditions for many different applications, such as:

  • Microbiology and analytical labs.
  • Research institutes and examination agencies.
  • Bio-Technologies and life sciences.
  • Animal facility and clinical diagnostic labs.
  • Pharmaceutical, food, chemistry industries, QC labs.
  • Hospital operating theaters and medical care.
  • Agricultural, environmental and veterinary labs.

These sterilizers have been specially designed with ergonomical features for easy handling of higher volume sterilization materials and goods as: glassware, media preparation, liquids, in open and sealed containers, mixed regular and high risk waste, as well as surgery instruments, textiles, rubber articles for hospital use and packaged tools.

FOB4 Stand-alone Lab Sterilizer is easy to be configured, thanks to its conceptual design and modular construction with a convenient portfolio of optional kits. In fact, all the models can be configured using various customized systems guaranteed by the wide range of processes, software options and an extensive choice of accessories. Please, click on the link “recommended kit” to check out all possible configurations referred to FOB4 series.

DESIGN AND TECHNICAL FEATURES

FOB4 can be designed in two chamber dimensions: 147 liters (FOB4-TS) with single vertical sliding door or 210 liters (FOB4S-TS – FOB4/L TS) with double vertical sliding door for pass-through purposes. The vertically automatic sliding doors are pneumatically activated for space efficiency in laboratory and hospitals.

FOB4 autoclave has internal AISI 316L stainless steel plates fed by steam used both as heat-exchanger system for steam pre-heating and to cool the chamber temperature by means of cold softened water. As an option these plates can be used for drying purposes at the end of the cycle.

Fedegari designs laboratory autoclaves combining operators’ safety as well as equipment performances. FOB4 complies with TRB402 standards thanks to a thermal blocking system to prevent door openings in hazardous situations. Temperature probes and pressure transducers ensure constant process monitoring, as well as precision and optimal temperature distribution in the chamber, guaranteeing a high level of safety for the operator and performance and reproducibility of the sterilization process.

KEY BENEFITS

  • Energy and water cost-saving.
  • Small foot print with superior loading capacity.
  • Ergonomic positioning of adjustable operator display.
  • Full and easy accessibility to technical area from front and lateral sides.
  • Special test programs for routine check of sterilizer efficiency.
  • GAMP5 compliant.

Want to learn more about the FOB4? Give us a call at 800-829-5741.

The FPS2-SS is BACK IN STOCK FOR IMMEDIATE DELIVERY

Do you need help filling vaccines or other pharmaceuticals or chemicals?

It is our pleasure to announce that the Cozzoli FPS2-SS is IN STOCK and ready for immediate delivery. To have it shipped to you, please contact us at 800-829-5741. The FPS2-SS is a monoblock machine that can aid vaccine production worldwide.

The Cozzoli FPS2-SS can fill and seal ampoules at a top rate of 120 ampoules per minute with fill volumes ranging from .1ml to 33ml. This compact, stainless steel monoblock requires little to no human interaction and achieves a fill accuracy of +/-.5%.

The FPS2-SS features a built-in unscrambler, filling and flame sealing stations as well as a flushing station with inert gas before and after filling.

FPS2-SS requires little to no human interaction while in operation, making it extremely resistant to human related errors.

Call us today so we can partner with you in addressing your challenges. Reach us at 800-829-5741.

STERILITY TEST ISOLATOR with Built-in Hydrogen Peroxide Vaporizer

The FCTS Sterility Test Isolator has been designed for pharmaceutical samples taken from manufactured drug batches and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Suitable for:

  • Injectable liquids.
  • Ophthalmic ointments.
  • Sterile antibiotic powders.
  • Freeze-dried drugs.

When Fedegari started designing its first isolator, the goal was assuring customers the highest process reliability and repeatability possible.

FCTS sterility test isolator is equipped with the same solution that Fedegari has standardized in bio-decontamination pass-boxes, because the performances and the reliability of third party H2O2 vaporizers were not satisfactory. Moreover, with the FHPV there is no need of propietary consumables, reducing significantly operational costs.

This innovative design provides real time biocide concentration control (over traditional estimated calculations).

Through the H2O2 sensors and other devices, Thema4 assures that vapor concentration remains extremely constant (within ± 15 ppm) thus making process repeatability the logical consequence.

The FCTS sterility test isolator is compliant with the most stringent cGMP guidelines of Pharmacopeia. It has been classified as ISO 5 FDA and Class A EU GMP.

DESIGN & TECHNICAL FEATURES

  • Working chamber has non-directional BA surface finishing (Ra ≤ 0.4 μm).
  • Air-tightness is 100% guaranteed by ultra-safe doors.
  • Equipped with an internal stainless steel trolley for material transfer from pass-box to working chamber assuring continuous loading of the isolator with materials.
  • Customizable internal storage and racks: can be designed according to customers’ needs.
  • FCTS is modular: customers can choose the positioning of the pass-box, the number of working chambers and gloves.

KEY BENEFITS

  • Significantly reduced operational costs: Non-proprietary consumables.
  • Reliability: Leak testing totally managed by Thema4.
  • Easy integration, throught Thema4, with other Fedegari machines and SCADA systems.
  • Cost-effectiveness: Drastically reduced validation time for cycle and load.
  • 100% air tightness: Silicon inflatable patented gasket on all doors.
  • Process control based on direct feedback, instead of estimations.
  • Grids and internal spaces that can be customized according to the load.
  • RTP Port for loading and unloading activities.

COMPLIANT TO

  • European directives: 2014/30/EU – electromagnetic compatibility (EMC), 2014/35/EU – Low tension equipment (LVD), 2006/95/EC – Safety of machinery (MD)
  • European standards: EN 55011, EN IEC 61000-4-2, EN IEC 61000-4-4, EN IEC 60204-1
  • FDA: compliance for non metallic component in contact with process fluids
  • GMP
  • GAMP5
  • 21 CFR Part 210, 211 e 11
  • UL 508A
  • NFPA-79
  • ASME BPE

Optional

  • US electrical norms: NFPA 70 – National electrical code,  UL 61010-1 – Safety requirement for electrical equipment for measurement, control and laboratory use – Part 1: general requirements.

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

The all new Bench-top Pentafill® L+Fill

The Pentafill® L+Fill is a Bench-top machine for filling and sealing single-dose plastic containers.

This Bench-top machine is suitable for lab research and small quantity start-up production that meets the same industrial sealing standards as higher capacity Pentafill models.

Whether you are looking to complete laboratory studies, or produce small start-up quantities of single-dose plastic vials, the Pentafill L+Fill allows you to mimic the results of industrial production in a compact, bench-sized sealing machine.

• Machine includes a heating head, cold-molding pliers and a sealer

• Strip holder requires manual movement

• Interchangeable holders for different containers capacities

• Simple external controls

• Pentafill supported formats: 0.33 – 0.6 – 1 – 2 – 3 – 5 – 10 ml

For additional information, please contact our representatives.

Fedegari Equipment used for Battling COVID-19

Fedegari is proud to partner with Wind River®, a global leader with nearly four decades of experience powering the safest, most secure mission-critical systems in the world, used also by NASA.

Recently, Wind River announced an important initiative to enable and accelerate the innovation of mission-critical systems during the COVID-19 pandemic.

The actions include donating software and design and implementation services for those making a difference in the COVID-19 battle.

The current COVID-19 crisis is fundamentally changing our reality with 81% expecting a negative effect on their workplace as a result. A rapid response to innovation to help our customers and communities is more critical now than ever.

A global leader with nearly four decades of experience powering the safest, most secure mission-critical systems in the world, Wind River is opening up access to its IP and expertise for the industry to leverage. The access is for companies manufacturing medical, 5G network, and industrial automation equipment that support the global battle against COVID-19. This includes Wind River customers like DraegerGE Healthcare, and Fedegari Autoclavi, among others that are manufacturing massive quantities of life-saving products, such as ventilators, patient monitors, and medical instrumentation devices.

For qualified companies, Wind River is donating software and services from its industry-leading portfolio for the intelligent edge. The actions Wind River is taking will address the significant challenges created by the pandemic, such as limited access to labs with appropriate hardware for development and testing, delays in the supply chains that put development timelines at risk, and barriers to innovation.

For a limited time, the company is offering the following tools, software, and services, which will be especially critical given the drastically increased number of workforces at home under pressure to design, develop, and deploy systems.

Powered by the Wind River platform, Thema4 is able to provide a wide range of control, visualization, and reporting functionalities. It also allows a high degree of customization and communication with a machine I/Os and other external devices.

What is Blow-Fill-Seal Technology?

This refers to advanced aseptic manufacturing in which the containers are formed, filled, and sealed in a single continuous automated system, within a sterile and closed area. It is mainly used to produce small (0.1mL) and large volume (500mL +) liquid-filled containers. Originally developed in Europe in the 1930s, it was introduced in the United States in the 1960s, originally used to food package and industrial products but over the last 20 years, it has become more prevalent within the pharmaceutical industry and is now widely considered to be the superior form of aseptic processing by various medicine regulatory agencies including the U.S. Food and Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products.

The process of creating BFS involves several steps. Pharmaceutical-grade plastic resin is heat-extruded through a circular throat to form a hanging tube called the parison. This extruded tube is then enclosed within a two-part mold, and the tube is cut above the mold. The mold is transferred to the sterile filling space, mandrels are lowered and used to inflate the plastic to form the container within the mold. After the formation, the mandrel is used to fill the container with liquid. Once filled, the mandrels are withdrawn, and a secondary top mold seals the container. All actions take place inside a sterile chamber within the machine. The product is then discharged for labeling, packaging, and distribution.

What makes Blow-Fill-Seal technology an ideal solution for pharmaceuticals?

Firstly, it reduces human intervention making it a more robust method for the aseptic preparation of sterile pharmaceuticals. It is widely used to fill vials for parenteral preparations and infusions, eye drops, and inhalation products. Secondly, the plastic containers are made up of polyethylene and polypropylene. Polypropylene is more commonly used to form containers that are further sterilized by autoclaving as it has greater thermostability. Thirdly, there is a reduced risk of particulate delamination, which could be in the case a glass packaging. Fourthly, it is a flexible solution: the resins can be melted into any shape to create the container of choice. Lastly, it is ideal for transportation as it is lighter than glass and positively influences the weight of the shipment and there is a lower risk of breakage during transport.

Should I test BFS packaging for integrity?

As with the many advantages offered by BFS packaging, there could be some downsides too, like with all containers it is certainly worth testing for container-closure defects. The EU guidelines state that “containers closed by fusions, e.g., glass or plastic ampoules should be subject to 100% integrity testing”. Thus, inspection becomes fundamental. The inspection of each unit will result in a reliable, final product examination that can identify defective units (e.g. “leakers”). There are a variety of leak-inspection technologies in the market, such as the vacuum-decay method (VDM) and high-voltage leak detector (HVLD). The vacuum-decay method (VDM) is often selected for biological manufacturing because of its zero-impact on product quality. During vacuum decay leak detection, the test article is placed inside a chamber, which is then evacuated to a known pressure. If the product container exhibits a leak, the chamber pressure will rise at a rate greater than a predetermined baseline value.

What should I consider when evaluating in-line leak detection for BFS packaging?

One of the main challenges with in-line leak detection operation is the high false rejection rate. Due to the high temperature required for plastic extrusion, the ampoules, immediately after the BFS process, are notably warmer than room temperature. When the products are immediately passed onto a vacuum-detection chamber, the heat from the ampoule can cause a slight increase in pressure which the instrument may interpret as a leaky sample, which will trigger a false rejection signal. Therefore, it is highly advisable to have the product equilibrated to room temperature prior to subjecting the product to vacuum leak detection.

What solutions does Bonfiglioli Engineering provide to combat BFS packaging leak detection challenges?

Bonfiglioli Engineering follows the procedure of Vacuum Decay Method which is Approved industry-standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages” and approved by United States Pharmacopoeia – USP General Chapter «1207» “Packaging Integrity Evaluation” and 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” as well as EMA Annex 11.

Handling BFS leak-detection for zero false rejections:

The measurement system adopted by Bonfiglioli Engineering comprises of application of a pressure differential into an airtight testing group enclosing the container. The test objective is to detect container leakages by measuring the reached vacuum level. It also measures the vacuum change over test time, so that a correct interpretation of the test results can be given, reducing false rejections. The PK-VS is a non-invasive and non-destructive, 100% in-line Integrity Inspection solution for BFS containers. It offers an automatic drying system for zero testing chamber contamination and offers a speed limit of up to 220 strips/cards per minute for container formats from a minimum of 40 x 40 x 6 mm to a maximum size of 150 x 80 x 15mm. https://www.bonfiglioliengineering.com/products/pk-vs/ The batch control is fast, reliable, and repeatable. The quick format change offers versatility for diverse container sizes. All this comes with remote access for machine data and exchange and real-time display of testing cycle diagrams and raw data. It also offers an automatic head exclusion.

Bonfiglioli Engineering also offers laboratory equipment for small batch testing and for feasibility studies. The LFS-11 is a Benchtop CFR21 Part 1 Compliant CCIT solution that offers Vacuum Decay Testing for various container types, with its quick format change over, including one for BlowFill-Seal. It is also equipped with a Barometric Compensation System to avoid any vacuum level reading variations and provides records storage for maintenance and statistical raw data with easy, quick, and safe remote access.

IFL – INLINE FILL-TO-LEVEL by Cozzoli

The Inline Fill-To-Level Models are moderate speed fillers, ruggedly designed, yet precision built for long, trouble-free liquid filling operation. Each model features a fill-to-level design with filling accuracy maintained to within +/- 1/16 of an inch of targeted fill level. The inline series includes three easy to operate models – manual, semi-automatic and fully automatic, with machine cycle speed up to 8 cycles per minute. Either gravity, pressure, vacuum, or combination filling systems can be utilized. A diverse range of products, including cosmetics, chemicals, food and beverages can be filled on these versatile machines.

IFLM – MANUAL FILLER

Suggested for use as either a lab model or as a small batch production line. The operator simply slides containers onto a stainless steel slide track to an adjustable stop point. The nozzles are now centered above the container openings. The operator lowers the spout bar, which brings the nozzles down into the containers and seals the openings. At this point, the filling cycle begins. When the operator sees product discharging from the overflow nozzle hose, the cycle is complete. The head is then raised and the container stop is manually released to discharge the containers.

IFLS – SEMI-AUTOMATIC FILLER

Model IFLS functions in the same manner as the IFLM, but is intended for future growth to full production capabilities. This machine is designed to be easily upgraded to a Model IFLA by adding a powered conveyor and PLC for a fully automatic unit.

IFLA – AUTOMATIC FILLER

Model IFLA incorporates an automatic conveyor and PLC to control the functions of the filling operation. Containers are conveyed into the filling area. When the correct amount of containers have entered the machine, the conveyor stops. The spout bar then descends, sealing the nozzles against the container openings. The containers are filled to the predetermined fill level, product overflow is then automatically returned to the reservoir. The filling cycle is completed based upon time factors programmed into the PLC. When the fill cycle is complete, the head is pneumatically raised, triggering the conveyor to restart, discharging the filled containers via the starwheel.

Contact Life Scientific to learn more about the models offered.

MEET THE RISING DEMAND Due to COVID-19!

In the grips of the Coronavirus outbreak COVID-19 testing is more important than ever, and many companies such as yours need help keeping up with growing demands. Our semi-automatic filler F400X and capper SC50T (for screw capping/crimping) are IN STOCK for immediate delivery. Also perfect for COVID-19 testing is our fully automatic RFPC, which can fill, plug/stopper and cap (or aluminum crimp seal) on one machine frame. Count on our 100 years’ experience serving customers like you!

Once a vaccine for the Coronavirus is developed it will be imperative to fill these vaccines and get them to market as quickly as possible. We can work with you now to give you a head start! Our F329HE/MVP combo (specifically designed to fill and stopper Hypak syringes) is ideal for injectable vaccines filled at moderate speeds (one tub of syringes can be filled in 35 seconds). Currently, we have the MVP stoppering system (which provides reliable semi-automatic batch insertion of stoppers, plungers or plugs into filled containers) IN STOCK for quick delivery.

Our ampoule filling FPS Series is also ideal for filling vaccines and can fill and seal ampoules at a rate of 15-120 ampoules per minute.

The Cozzoli product line provides a variety of solutions to help you meet the rising demand for COVID-19 testing. Additionally, our machines will let you fill not only future vaccines for COVID-19 but also drugs that will alleviate the many pre-existing conditions and ailments that have arisen and/or worsened due to COVID-19.

We are confident that we will ultimately triumph over this disease together, and we look forward to hearing from you so that together we can begin working on a solution that meets your and your customers’ needs.

Call us today so we can partner with you in solving your and your customers’ challenges.

FCIS – PHARMACEUTICAL ISOLATOR

Fedegari has decided to develop the FCIS pharmaceutical isolator to offer its customers a process machine capable of:

  • Ensure maximum safety in the handling and dosing phases of active ingredients and high potent substances.
  • To ensure continuity of sterility when unloading from a sterilizer.
  • To ensure aseptic filling in the production of sterile drugs.

The FCIS unit physically separates the operator – who works in a class C or D EU cGMP (ISO7, ISO8 US cGMP ) environment – from the work chamber that ensures a class A Eu cGMP (ISO5 US cGMP ) environment. The isolator complies with FDA , EMA and WHO standards and associated pharmacopeias as well as all applicable EN standards and directives.

The FCIS pharmaceutical isolator has a side door for the passage of material and to remove any waste after the process. To avoid false positives, a standard FHPV peroxide generator is supplied, thanks to which it is possible to launch a cycle of chemical decontamination of the work surfaces before starting to use FCIS. This allows you to be sure of working in an aseptic environment.

Fedegari has installed on FCIS the same solution that is provided in the FCDV decontamination pass-boxes because the reliability of third-party generators was judged insufficient. A further advantage of the Fedegari peroxide generator is that it does not require proprietary consumables, reducing the running costs of the machine.

Thanks to the presence of sensors in the chamber, the concentration of the hydrogen peroxide vapor are directly monitored in real-time by the Thema4 process controller (against the estimate that is generally carried out by others) and remain constant in the chamber, ensuring certainty of results and repeatability of the process.

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