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

The most versatile testing solution available

The SAIL is Bonfiglioli’s new automated inspection laboratory for different container types, sizes, and content bringing together CCIT, AVI and HGA technologies is an all-in-one machine that is suitable for in-process control, clinical trials, and laboratory use.

HIGHLIGHTS

 SAIL modular structure provides adequate flexibility upon all 3 of testing technologies:

– AVI (Automatic Visual Inspection)/ SAVI a collection of images is acquired using high resolution matrix cameras under designed illumination conditions.

– CCIT (Container Closure Integrity Testing) non-destructive integrity testing in packages by Vacuum Decay Method.

– HGA (Headspace Gas Analysis) inspection process is based on the Tunable Diode Laser Absorption Spectroscopy (TDLAS) method which accurately quantifies gaseous concentration levels.

• All in one Industry 4.0 based
   laboratory
• Ergonomic workstation
• Scientific and objective inspection
• 100% traceability
• Time & cost saving

SAIL modular structure provides adequate flexibility for all 3 testing technologies:

– AVI (Automatic Visual Inspection) /SAVI

– CCIT (Container Closure Integrity Testing)

– HGA (Headspace Gas Analysis)

The testing methods conform to current pharmaceutical regulations, such as FDA 21 CFR Part 11 and EU Annex 11USP General Chapter <790>ASTM F2338-09USP General Chapter <1207>EU Annex 15 and GMP requirements.

Contact our offices today to learn more about the SAIL.

CLEANING GUIDELINES VALVE ASSEMBLES AND SYRINGES

Regularly scheduled preventive maintenance minimizes downtime and assures trouble-free operation!M

Cozzoli’s exclusive sliding valve assemblies and precision honed syringes are mated for life and operate as matched sets on liquid fillers.

Each set is engraved with matching serial numbers that correspond accordingly. It’s important never to mix up or interchange designated serial numbers with other valves and syringes, as damage and poor operational permanence will result.

DISASSEMBLE AND ASSEMBLE

When disassembling, always withdraw the piston in a straight, horizontal line in reference to the valve or the syringe body.

Reverse this procedure to assemble.

Never use force, as it will cause the components to jam.

BEFORE USING

Before the initial use of valve assemblies and syringes, clean and rinse with a solution of soap and water, then flush thoroughly with clean water.

Place them on a lint-free cloth or paper.

Do not allow components to come in contact with contaminants or other metal parts after cleaning.

AFTER USING

Product should not be allowed to dry in the valves and syringes since it could cause them to score or seize.

Always disassemble them and clean properly with an appropriate solution that will remove product.

A bristle brush with a plastic center may be used. Blow dry components thoroughly to ensure that they are free of foreign particles and watermarks. When autoclaving, be sure that the piston is removed from the valve or syringe body.

WHILE IN OPERATION

Valves and syringes should never run dry while in operation. Either product or water must be present.

HANDLE WITH CARE

Proper valve and syringe handling is essential. Dropping, hammering on or restraining them in a vise may damage and render them inoperable.

PRIOR TO INSTALLATION

Check action of valve and piston within syringe cylinder to ensure smooth performance prior to installing on filler.

STORAGE

Between uses, valves and syringes to be stored wrapped in a lint-free cloth or paper.

This is necessary to avoid contamination and contact with other metal components.

Contact our offices to learn more about Cozzoli Machine Company and their comprehensive product line.

Table top Container Closure Integrity Tester

The LF-S11 by Bonfiglioli is a countertop compact machine, designed for Non-Invasive, Non-Destructive Container Closure Integrity Testing of diverse types of Pharmaceutical Containers filled with liquid, lyo, powders, etc..

Suitable for In-Process Control and Laboratory use without altering container and/or content features.

The integrated software system allows full compliance to provisions stated in FDA 21 CFR part 11 as well as EMA Annex 11.

3 Configurations of the machine available to meet all specific requirements:

– BASIC, for most of the container formats 

– XL, designed specifically for large formats (more than 100ml)

– SY, designed for syringes, carpoules including automatic plunger stopping device

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”

All dedicated test chambers are designed according to the container characteristics for a maximum of leak detection sensitivity and are monitored by specially developed electronics during the testing process. The group has been recently redesigned to obtain improved functionality (quick

 single-handed opening and closing). It is directly installed onto the Testing Chamber supporting flange and it is composed by: – A fixed bottom part; – A removable top cap (upper part) that allows plugging up the testing group corresponding to Container loading and unloading operations.

HOW IT WORKS

The test chamber fixed bottom part is equipped with a mobile piston, plunger stopping device (PSD), having vertical motion between two limit positions, “upper” and “lower”, and having a section equal to that of the PFS plunger.

The initial vacuum, generated in the test chamber, produces an upward movement of the PSD.

The same “upper” position is kept until the second reading; at that time, the action of a dedicated pneumatic actuator provides for exhaust of vacuum in the test chamber bottom area and produces the PSD downward movement towards the “lower” position.

For more information, please call our office and we’ll be happy to assist.

REVAMP YOUR OLD MACHINE FOR A NEW LIFE CYCLE

Did you know that 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: JETS system.

JETS is a full-featured implementation of the Java SE platform, optimal for embedded systems. It 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 

Only 5 working days for installation!
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 by calling 800-829-5741

Cozzoli EXCLUSIVE OFFER!

Now until the end of 2018, take advantage of a 15% discount on parts and ensure your Cozzoli and MRM/Elgin machines are in peak condition!

A way to recondition an outdated machine, restoring it to optimum performance at a fraction of the cost and time of purchasing a new machine. We can perform small retrofits through whole overhauls either at your location or in our state of the art facility.

 

Offer Includes

  • 15% discount on parts
  • Discounts on preventative maintenance
  • Consultation service call comped when recommended action is taken

 

Cozzoli currently offers multiple maintenance packages:

  • 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

 

Preventative Maintenance can help limit downtime. Contact us today to set up a one time evaluation or arrange regularly scheduled inspections to check the condition of your machinery.

 

Restorative Maintenance keeps your machines running at maximum efficiency. Our Tech Service Department can advise replacement of wear parts and recommend improvements and/or upgrades. Parts may also be sent in for an estimate of repair/reconditioning.

 

Cozzoli and MRM/Elgin Machines, also offer Operational & Maintenance Training for new employees and refresher courses for experienced technicians. We will provide your team specialized training on your Cozzoli and MRM/Elgin machinery.

 

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

Call 800-829-5741 for more information.

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