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!

PHARMA TECHNOLOGY FOR LABORATORY SOLUTIONS

More than 60 years manufacturing components, systems and sub-systems in-house for the most demanding users. An in-depth knowledge hard to beat. Fedegari laboratory range offers to customers all the innovation already tested in the pharma industry. The same components, the same process controller, customized to meet specific laboratory needs.

Today, Fedegari is the only manufacturer of lab equipment that is developing its machines by adopting sophisticated solutions already field-tested on the pharmaceutical market by the most demanding users.

Thema4LabTHE PHARMA PROCESS CONTROLLER CUSTOMIZED FOR LAB APPLICATIONS

Engineered and pre-validated by Fedegari according to GAMP 5, Thema4Lab process controller is a revolutionary solution: a completely customized system for laboratory needs that benefits from the pharmaceutical expertise of the industrial Thema4 process controller. This innovative system guarantee a reliable and cost-effective process development and is already available on FOB5 steam sterilizers and FGW glassware washers.

FGW LAB WASHER – FEDEGARI EXPANDS ITS RANGE OF LABORATORY SOLUTIONS 

Fedegari’s latest innovation for laboratory market is a glassware washer that capitalizes the experience acquired with the FOWS-series of washers in the pharmaceutical market. The new FGW lab washer, in fact, uses a steam generator to improve washing performances reducing operating costs. This true eco-friendly solution minimizes the use of detergents as well as water consumption. Not only, the pre-validated Thema4Lab process controller uses a conductivity meter to terminate the process as soon as the desired set point is reached thus further reducing water and other utilities consumption.

The piping, as for any other equipment manufactured by Fedegari, has a rigorous sanitary finishing. The machine is then loaded with a modular, customizable rack that can be easily adapted to all load configurations. As for all Fedegari lab equipment, the FGW complies with cGLP standards. FGW external trolleys are interchangeable with FOB5 steam sterilizers and components are standardized for both machines representing a cost-effective solution for high performance laboratories.

Contact our corporate offices at 800-829-5741 for further information.

Summer Savings for Revamping Your Bonfiglioli Machine!

Take advantage of Bonfiglioli Engineering summer sales!

For your routine machine maintenance and revamping or just ordering spare parts, purchase them before the end of the summer and capitalize on the Bonfiglioli special offer!

When you purchase spare parts during July and Augustyou will benefit from an exclusive 10% discount

Contact us to receive your personal quotation. Call our corporate offices at
800-829-5741.

Opportunities like this don’t come knocking on the door twice!

Automatic Product Detection Torque Testing Head

While automated torque testers eliminate the ergonomic concerns of manual torque testing, they often require a trained mechanic to adjust the hardware and software configuration when changing over from one product to another. To overcome the complexity of the setup, Mesa Labs is now offering magnetically coded locator bases.

Features:

  • Environmentally friendly 3D precision printed acrylic locator bases
  • Highly resistant to corrosion and typical cleaning materials (IP, H2O2, Spor-Klenz), ideal for pharmaceutical cleanroom areas, beverage and chemical production facilities
  • Eliminates the need for mechanical and software setup adjustments
  • Custom engineered for each unique product for horizontal (centering) and height positioning
  • Unique, 5 position magnetic coding allows the automatic identification of up to 32 products
  • Available as an option for ST-S3 and ST-120s torque testers
  • Compatible with tubes, vials, and most pharmaceutical bottles*

*Sample bottles/caps are required for compatibility testing

For more information on the current Torque Testing Solutions we provide give us a call at 800-829-5741

Ampule Filling and Sealing Machines

Cozzoli’s stainless steel FPS Series is ideal for filling and sealing ampules with speeds from 15-120 ampules per minute and a fill accuracy of +/- .5%. The FPS is designed with a sealed top cover plate to ensure the internal drive mechanism remains free of extraneous matter.

The FPS series is a compact ampule filling and sealing monoblock machine; featuring an unscrambler, flushing and filling stations and is known for it’s simplicity, operational reliability and minimal maintenance factors.

Utilizing Cozzoli’s exclusively patented sliding tube valve, the FPS uses stainless steel syringes and positive head pressure to fill product with outer diameter dimensions up to 1” (25.4mm) at full speed. Ampules from 25.4mm to 28.6mm can be handled by alternate indexing.

Fill volume can be changed by a simple adjustment of a calibrated sector arm. Volumetric accuracy of fill is +/- 0.5%. Bottom-up filling is provided through the provision of two cams to lower and raise on a 2” or 5” stroke. Other cams are available for any special bottom up filling requirements.

Since the blending of proper amounts of oxygen and gas is important for effective sealing of the ampule, this machine can be optionally equipped with a dual flow meter assembly that will visually indicate the oxygen and gas flow separately.

Contact our office to learn more about our Ampule filling solutions and to discuss current pricings.

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

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 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

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