About Marko

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.

Last chance to network with our manufacturers at the Interphex

Bahnson Environmental Specialties are at Interphex at the Javits Center, New York. Stop by Booth 1945 today, to discuss their complete line of Walk-in and Reach-in controlled environmental chambers designed for diverse pharmaceutical applications including: high volume, ultra-low temperature freezers; clean-cold rooms; ICH stability and photo-stability chambers; CO2 chambers; and freeze-thaw/ramping chambers. Also ask about our custom design capabilities to meet your most demanding and critical applications.

Fedegari Group’s team of experts is getting ready for the final day of the Interphex NY. Visit their Booth #3461 to see their innovative prototypes and explore our solutions for cost-effective pharma manufacturing sterilization!

Make sure to stop by and visit Cozzoli in booth 2508. You’ll have the chance to see the newest filling machine, the F400X is a single piston filler designed for smaller scale operations that require a high level of accuracy. With fill volumes up to 60ml and a fill accuracy of +/- .5% it is ideal for alcohol, light oils and other low viscosity applications.

LF of America is ready to show the new A15 filling machine designed to be closer to the needs of the sterile filling environment. Additionally you can get free samples of their most popular and innovative packaging molds as well as witness how that packaging is filled by the versatile A15 filling machine. Come see us at booth # 1235!

If you would like to schedule a meeting with our project engineer attending, call MaryBeth 217-825-8110

The Interphex NY starts today!

Looking forward to a fantastic Interphex2019!

Visit Fedegari at Booth #3461 to see their prototype for the best performance in pharmaceutical manufacturing sterilization…that’s 3 separate processes in 1 integrated machine! You really can’t risk missing this one.

LF of America is ready to welcome you at Interphex 2019, come see their exhibits at booth # 1235!
Lameplast is ready to show the new A15 filling machine designed to be closer to the needs of the sterile filling environment. It’s the center piece of their booth and will be doing demo runs for all visitors, customers and friends.

Stop by Booth 1945 to discuss Bahnson Environmental Specialties complete line of Walk-in and Reach-in controlled environmental chambers designed for diverse pharmaceutical applications including: high volume, ultra-low temperature freezers; clean-cold rooms; ICH stability and photo-stability chambers; CO2 chambers; and freeze-thaw/ramping chambers.

Also ask about our custom design capabilities to meet your most demanding and critical applications.

If you are already attending Interphex 2019, Make sure to stop by booth #2805 and check out Cozzoli’s new RFPC machine, along with several of their other filling and closing solutions.

Don’t forget to visit https://bit.ly/2SvDiio to register for your free attendee badge.

If you would like to schedule a meeting with our project engineer attending, call MaryBeth 217-825-8110

ARE YOU READY FOR INTERPHEX 2019?

One week until Interphex 2019!

Come visit Cozzoli at booth #2805 in New York, NY on April 2-4. The main center piece at their booth will be the RFPC. Cozzoli’s RFPC rotary monoblock fills, plugs and caps in one compact solution. It also accomodates a wide range of products from aqueous to heavy oils, suspensions and creams.

Get in touch with our managers if you are interested in scheduling a meeting during the expo.

Our fill and seal machine and packaging manufacturer LF of America will be setting camp at Booth: 1235.

LF of America is a full service contract manufacturer for the pharmaceutical and personal care industries. Our services include packaging development and manufacturing, product manufacturing, contract filling of liquid solutions in sterile environment and in ISO 8 cleanrooms, fill and seal machine manufacturing for our proprietary unit-dose vials.

Fedegari to demonstrate integrating advanced robotic technology into aseptic processing and contamination control at Interphex. Fedegari Group is a leader in the design and manufacture of state-of-the-art custom moist & dry heat sterilizers, washers, chemical bio-decontamination units, contamination control solutions and integrated systems with robotized handling. Fedegari systems meet or excede the highest global standards. A unique feature of Fedegari is its commitment to develop, manufacture and service components and technologies in-house at its own facilities around the world. Fedegari Amercia’s U.S. headquarters and Tech Center is located in suburban Philadelphia, PA. The Tech Center is designed to be an industry resource for hands-on testing & training, replicating activities at actual bio/pharma manufacturing plants.

Fedegari will be setting up their showcase at booth 3461.

Our environmental specialists Bahnson Environmental Specialties, LLC. Presenting our complete line of Walk-In and Reach-In Controlled Environmental Chambers designed for diverse pharmaceutical applications including HEPA Filtered Cold Rooms, modular and traditional Clean Rooms, Stability Chambers exceeding ICH guidelines and high capacity -75°C Cascade low temperature storage chambers. BES will present information on our 3 unique High Volume Freezer designs for the biorepository storage market that allow reduced dependence on small unitary freezers.

You can stop their booth at Booth: 1945

Don’t forget to sign up below to receive your free attendee badge.

Visit this page to get your Free Badge.

If you would like to schedule a meeting with our project engineer attending, call MaryBeth C. 217-825-8110

Meet Fedegari @ Interphex NY

Fedegari is getting ready to showcase the latest developments on contamination control and aseptic processing at the Event for Pharmaceutical & Biotech Professionals – INTERPHEX New York 2019. 


Join us to explore the highest performances of Fedegari unconventional solutions for pharma manufacturing. At our booth, you will be able to see the integration of different Fedegari processes and technologies, but not only. 


Come and visit us at Interphex New York, Javits Center – Booth #3461!

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