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A way to recondition an outdated machine, restoring it to optimum performance at a fraction of the cost and time of purchasing a new machine.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.

All-in-One Contract Filling & Packaging Services

LF of America’s intent on becoming something more than simply one of the leading contract liquid filling companies in Florida. Though finding innovative packaging solutions for liquid products across a variety of industries is what has permitted us to grow into a nationwide leader, our true commitment is to help our clients succeed.

We reached a level of prominence with an FDA-registered facility that is equipped with some of the most advanced automatic packaging machines currently available. Our latest automatic filling and sealing machines are capable of achieving impressive levels of production that remain unmatched by our competitors.

This article is meant to convince you why we believe our company is the all-in-one, best contract filling company. However, if you’ve already been persuaded and would like to begin moving forward, contact us to get started today.

Aiming For Shared Success

Properly sustaining success in the contract filling and packaging industries is about more than just having the best packaging manufacturing equipment or filling and sealing machinery. The most important factor to us is developing an established relationship with each of the clients that choose to contract one of our various services.

So whether it is in contract filling cosmetics for a health and beauty company or manufacturing packaging for OTC medications for a pharmaceutical company, our hope is to accomplish something more. The mission we believe in is to be the premier option for US contract liquid filling companies so that your own business can accomplish whatever ambitions you set out to achieve.

How Can LF of America Help You Succeed

LF of America provides a variety of different services in order to be ideal turnkey partners for packaging liquids. Our first specialty was finding innovative packaging solutions for cosmetics and pharmaceuticals, such as unit dose packaging and the Bellow Bottle.

Now we are well-known providers for all of our different services, establishing success across the board. We offer product packaging manufacturing for liquid products that are new or simply            re-branding.

We also provide contract filling and sealing services in our FDA-registered facility in Boca Raton, FL. Our new automatic filling and capping machine is able to handle a high volume load that safely fills bottles and prepares ready for widespread distribution.

In fact, we even offer new automatic filling and capping machines for sale to those companies that wish to become completely independent themselves. If you are looking to buy a filling and capping machine, please contact us for pricing.

 

If you would like to learn more call 800-829-5741 today.

Fully automatic labelling system for glass or plastic syringes

The Newman NVS2 Labelling Machine is a fully automatic, self-adhesive labelling system designed for glass or plastic syringes and other similar cylindrical containers.

 

The NVS2 is a fully automatic, self-adhesive labelling system designed for glass or plastic syringes and other similar cylindrical containers.

The system was specifically designed to meet the requirements of the international pharmaceutical industry and all the regulatory bodies, including the FDA.

 

The product is fed into a vibratory feed track either directly from the customer’s existing upstream equipment, by hand, or optional syringe feeding system. From the vibratory track, product enters an indexing starwheel for transfer to the label applicator assembly.

For accurate label placement each individual label is detected at the labelling point as it passes beneath a sensor, (product orientation available as an option), at which point the label feed is activated. The leading edge of the label is driven off the backing web at a linear speed which matches the container speed. This ensures highly accurate label placement.

 

These are the key Features of the machinery:

  • Stainless steel construction
  • cGMP design
  • Stepper motor drive for label web
  • Straight label arm, adjustable in all axes
  • Accurate label placement
  • Indexing star wheel principle
  • Interlocked guarding
  • Stainless steel vibratory feed track
  • Allen Bradley or Siemens PLC controls
  • Two line LCD message display
  • Full variable speed drives
  • Left or right label formats available
  • Quick release change parts design
  • Infeed queue switch control

 

Also the Newman NVS2 Labelling Machine comes with a lot of optional extra capabilities:

  • Hot foil, thermal transfer, laser and inkjet printing options
  • Missing overprint detector
  • Missing label detector
  • Bar code reading systems
  • Vision Systems for OCV / OCR / barcode
  • Reject station for missing label, faulty / missing overprint and barcode with reject verification
  • Validation documentation package and implementation
  • Easisplice 470 module enables reel changes without labelling downtime
  • Product orientation to label
  • De-nesting systems for product feeding
  • Manual or online product feeding
  • Back-up queue switch control

 

Our company provides a lot of equipment, packaging and services regarding glass or plastic syringes. Get in touch with our product specialists to inquire further information 800-829-5741

CONTAINER CLOSURE INTEGRITY TESTER

The LF-SMH by Bonfiglioli engineering is an offline multi head container closure integrity tester.

The Machine is suitable for laboratory applications, statistical purposes as well as off-line testing.

The Measurement System comprises applying a pressure differential into an airtight Testing Group enclosing the Container (Patent No. 1225063 of 13-9-1988). The test objective is to detect Container leakages by measuring the reached pressure level as well as the pressure change over test time.

The Measurement System follows the approved industry standard “ASTM F2338-09”

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

 

This machine is capable of testing up to 8 units per session and the complete cycle from start to finish is concluded in less than 90 seconds. The unique design of the machinery allows the users to handle multiple types of containers like Vials, Pouches, MDPI, MDI, IV Bags, Flowrapped Device, Bottles, Liquid Forms.

This machine is also capable of testing empty containers used for injection molded filling, filled containers whether they are closed, sealed or open.

Beside liquids, the LF-SMH can also perform tests on containers filled with powder or semi-solid content. This laboratory leak detection tester emphasizes the vacuum decay testing method which when operated at full speed in appropriate testing environment can perform up to 20 calculations per minute.

 

For more information regarding the LF-SMH or for other vacuum decay testing solutions please reach out to our product specialists at 800-829-5741

FGW: Free Standing Washers

The NEW Fedegari FGW is a glassware washer unit for laboratories, capable of performing a complete washing cycle composed of the following phases: pre-washing, washing, rinsing, acid/chemical additives rinsing, purified/DI water rinsing, drying and cooling.

Thanks to its dedicated process controller and to its special design that allows steam to be injected directly in the chamber, this machine is suitable for use in many different applications

Key Features
  • High level of programming and application flexibility with fully configurable cycles
  • Full traceability and documentation in order to meet the most stringent worldwide safety and quality standards
  • Sanitary components and CIP to ensure a perfect washing
  • Energy saving thanks to the use of steam and the recirculation of the water
  • Vertical automatic sliding doors, effortless pneumatically operated
  • Doors, chamber and piping components made of sanitary AISI 316L stainless steel
  • Ergonomic loading height
  • Built-in steam generator (0.5 bar)
  • Stainless steel (AISI 316L) modular internal rack with automatic connection to hydraulic circuit

Click here to see the product brochure, alternatively:

Contact us at  800-829-5741 for more info.

Liquid Packaging Containers For Animal Care

 

The importance of each and every one of the animals in our lives is significant. This means caring for animals in much the same way that we care for ourselves, including veterinary healthcare. To ensure safety, liquid packaging containers for veterinary medication must be closely attended to and treated as carefully as pharmaceutical packaging.

LF of America is proud to be the premier choice in the contract packaging industry, including veterinary contract packaging for products intended for pets, livestock, equine, cattle, and other animal health. All of our available liquid packaging containers for veterinary medicine are designed to ensure maximum safety for the sake of the animal’s health and safety.

The animal prescriptions in veterinary healthcare must be filled and sealed in liquid packaging containers that meet the strict cGMP guidelines and regulations put in place. Learn more about some of the different types of plastic containers suited for veterinary medicine in the article below.

If you are interested in inquiring about the elite veterinary contract packaging solution, click here to read about our featured automatic filling machine for plastic containers.

Types Of Liquid Packaging Containers For Veterinary Use

Veterinarians and animal owners alike understand the varying factors that can make administering animal medication difficult. Though most animal prescriptions have the intended purpose of preventing disease or treating infections, there are plenty of other animal products that help pets in countless ways.

What this leads to is a diverse collection of liquid packaging containers that are uniquely suited to fulfill an intended purpose. For instance, unit dose packaging in veterinary medication makes it simple for someone to administer a pre-filled single dose of liquid medication without the need to measure out the right amount.

It’s also true that many types of veterinary medication require the veterinarian to be able to operate and administer it using only one hand. To address these challenging issues, LF of America provides a full catalog of different liquid packaging containers available in all kinds of colors, shapes, sizes, and designs.

Some packaging examples of animal products and veterinary medication include the following:

  • Eye Care (drops, tear stain removal)
  • Ear Care (cleaner, deodorizer)
  • Flea & Tick Treatment
  • Livestock Treatment
  • Oral / Gum Care
  • Single Dose Medicine
  • Wound Care

Click here for more information about our custom packaging manufacturing service.

Veterinary Contract Filling Solution

LF of America is an established turnkey partner with full veterinary contract filling services available. Our FDA-registered facility is located in Boca Raton, Florida and we are proud to be the only US-based partner of the world-renowned Lameplast Group. We perform our contract filling services using an innovative method that eliminates exposure to heat, reducing the potential for product damage during the packaging process.

Contact LF of America to learn how to go about receiving a free sample of our liquid packaging containers or call us at 800 829 5741 to let us know however else we can help you achieve your veterinary packaging goals.

 

Cozzoli Machine Company is your source for complete packaging and filling solutions

For nearly a century, Cozzoli has provided technologically advanced machinery for the packaging industry. Cozzoli is a global leader in the design, manufacture, distribution, and service of precision cleaning, sterilizing, filling, and closing systems. Quality craftsmanship has always been the cornerstone of our foundation and we are dedicated to continuing that tradition of excellence. The products we engineer today are designed to take you beyond tomorrow, because at Cozzoli research and development doesn’t end when a system is successful. We continually update our methods and equipment, integrating fast moving technologies that shape the products we provide worldwide.

Our expertise lies in the engineering and manufacturing of exceptional equipment custom designed to your specifications for a multi-faceted turnkey operation. As a single source provider of individual components through full lines, our projects are defined by your individual requirements. We utilize on-going technologies with design features that save time in product changeover and enhance productivity. Rugged construction and dedicated workmanship you can depend on contribute to an efficient smooth running operation.

Their most comprehensive capabilities include application analysis, product development, line integration, validation, parts and service, and installation. Whether you are a long time customer or a new client, Cozzoli will give you the same careful attention and unparalleled service.

Aseptic and non-aseptic pharmaceutical, cosmetic, health, beauty aids, personal care, food, beverage, chemical, paint, and industrial products are some of the industry segments Cozzoli serves.

 

Reach us now at 800 829 5741 and let us know how we can help you, with your next project.

Container Closure Integrity Testing Method Development and Validation for Prefilled Syringes

Utilization of prefilled syringes as a preferred container closure system for biologics has been increasing [1]. As a primary container closure system, prefilled syringes must provide an integral barrier that protects drug product stability and sterility throughout its entire shelf life. Drug manufacturers are required to check and demonstrate the system is capable of maintaining its microbial barrier integrity [2, 3]. In 2008, FDA further promoted container and closure system integrity (CCI) testing as a component of the stability protocol for sterile products

In response to the increasing regulatory expectations, the pharmaceutical industry has driven and witnessed significant technical advancements in CCI testing [5]. Instrumentation-based technologies, such as high voltage leak detection (HVLD) [6], vacuum/ pressure decay [7], mass extraction [8], and tracer gas detection (helium, oxygen etc.) [9, 10], have emerged and demonstrated improved detection capabilities compared to conventional dye and microbial ingress methods. Many of the technologies have been used for on-line 100% inspection and/or drug product stability CCI testing. In this article, we highlight our current thinking in an attempt to devise a systematic approach for CCI testing method selection, development, and validation.

General Considerations

In order to function both as a container closure system and as a drug delivery device, prefilled syringes feature many unique design elements. They usually include multiple containment compartments that are sealed by numerous interfaces. For example, the current stake needle glass syringes (Figure 1) provide a syringe barrel compartment for drug product containment and a separate needle shield compartment for needle protection. The syringe barrel compartment is sealed by the plunger on one end and by the needle on the other with the needle tip embedded in the needle shield. The needle shield compartment, sealed by the syringe barrel head,protects the needle exterior surfaces from potential contamination. The potential failure modes associated with each compartment and seal interface need to be identifi ed, assessed, and taken into account during CCI testing method development.

“In order to function both as a container closure system and as a drug delivery device, prefilled syringes feature many unique design elements.“

Furthermore, the plunger in a prefilled syringe is allowed to move within a range along the syringe barrel. When experiencing lower pressure environment during shipping and distribution, plunger movements in response to pressure variations may potentially aff ect seal integrity. Therefore, it is essential to evaluate plunger seal integrity following these special conditions.

In addition to the complex designs of prefilled syringes, the drug products packaged therein should also be considered. For example, prefilled syringes have been widely used for biologics, some of which could require extremely low temperature storage (e.g. -70°C). Since seal property of syringe components, especially elastomers (e.g. needle shields and plungers), is temperature dependent, CCI testing under extremely low temperatures could be required if theoretical justifications based on elastomer property are not adequate [11]. Moreover, drug-package interactions may impact method sensitivity and selection. For example, proteinaceous products could prevent mass transfer through CCI defects and reduce the sensitivity of a vacuum decay method [12].

Figure 1. Illustration of a stake needle glass syringe

CCI testing strategy for development

Many distinct CCI failure modes can occur throughout the life cycle of a syringe, ranging from component manufacturing, drug product filling and sealing, device assembling and packaging, to subsequent distribution and storage. It is essential to develop an overarching strategy to apply a series of CCI testing throughout the entire syringe life cycle.

CCI testing strategy development started with thorough understanding of syringe construction, design, and manufacturing processes. The CCI failure modes and eff ects associated with each aspect were first identifi ed. Using a risk-based approach, we further determined whether CCI testing is required, and if so, the intended uses and testing frequencies needed. For example, knowing the needle shield compartment seal integrity was tested by the component supplier, we elected to apply a non-routine CCI test to confirm its seal integrity upon drug product filling and sealing, and upon being assembled into devices. In contrast, for the product-containing syringe barrel compartment, we incorporated an extensive set of CCI tests into the entire product development cycle, including initial design confirmation, machinability studies, and product stability testing, to ensure CCI was achieved and well maintained.

Method selection

Table 1 lists the major CCI testing technologies available for prefilled syringes and their key characteristics. Note all the technologies have major limitations. When selecting appropriate methods, the following key aspects should be considered.

  • Suitable for its intended use. The selected method(s) must be suitable for the intended use and scope of a specific CCI test. For example, microbial ingress testing, although a good selection for media-filled syringes for fil lling process validation, cannot be used for stability testing because it does not apply to drug product filled samples. If a single method cannot meet all the testing needs, complementary methods may be applied in tandem to achieve definitive and comprehensive testing conclusions.
  • Applicable to the specific drug product-package. As previously mentioned, drug products can interact with CCI defects in various ways and may further aff ect the eff ectiveness of CCI testing methods. The method applicability to the specic product-package must be evaluated and adequately demonstrated.
  • Detection capability and eff ectiveness. Recent technologies utilizing mass extraction [8], HVLD [5], vacuum decay [7], have demonstrated reliable detection of CCI defects of 5-10 microns or smaller. These technologies are based on quantitative measurement of certain sample characteristics that can be further correlated to presence and/or sizes of CCI defects. The superior sensitivity and reliability made them preferred CCI testing methods over conventional dye or microbial ingress tests.
  • Non-destructive CCI testing. Non-destructive methods enable 100% CCI testing. In addition, they allow for further analysis of the failure modes and root causes, which in-turn provides valuable feedback for continuous improvement.

Method development

Upon establishing a preliminary method following vendor’s recommendations or literature search, we further focused on optimizing testing parameters and determining the appropriate pass/fail threshold.

Optimize Testing Parameters

First, various defect standards of known sizes (Table 2) were tested along with intact samples under different testing parameters. The correlations were thoroughly explored between key method parameters and instrument responses to intact and defect samples, aiming to identify a set of parameters that yield optimized separation between defect and intact samples (i.e. signal-to-noise ratio).

Refine Pass/Fail Threshold

To establish the preliminary pass/fail threshold, the optimized method was used to test multiple lots of filled intact syringes representing relevant product variations, including various packaging component sources/lots, drug products batches, as well as packaging sites and lines. The testing results were statistically evaluated to define the instrument baseline and variation (σ) for intact samples. Ideally, the pass/fail threshold should be at 10σ above baseline (i.e. above limit of quantitation LOQ). Defect standards of known sizes were then tested to further finalize and verify the pass/fail threshold. In cases where the 10σ threshold did not provide the desired sensitivity (as illustrated in Figure 2), the threshold setting was further adjusted between 3σ above baseline (i.e. limit of detection LOD) and the 10σ LOQ to achieve the desired detection sensitivity while keeping false positive detection probability (i.e. intact sampled detected as Fails) within the acceptable level.

Verify Method Effectiveness

Although defect standards are essential for initial method definition and optimization, they do not necessarily fully represent natural CCI defects. Natural CCI defects are of a large variety and most of them are not simple orifices or tubes. Therefore, the method performance was further evaluated using “real-world” CCI defects.

A good “real-world” defect sample set should represent all major probable CCI failure modes. Actual CCI defects could be obtained from various sources, such as reject samples from incoming or inprocess controls. When actual defect samples were not available for a specific failure mode and defect type, simulated defects were used.

A few iterations of the steps above may be needed to finalize the method. For methods used for stability testing, additional studies were performed to verify the methods are capable of detecting “aged” samples. Usually it was demonstrated by placing a set of productfilled samples with known defects on a stability study and testing the defect samples at various time points.

Method validation

Table 1. Characteristics of Major CCI Testing Methods

Table 2. Commonly-used CCI Defect Standards

In general, ICH analytical method validation guideline [14] was followed to validate instrument-based CCI testing methods. The key method characteristics, such as detection limit, range, accuracy, precision and robustness, were evaluated and demonstrated during the validation stage. In order to demonstrate detection capability in size, micro-pipettes, microtubes, and laser drilled standards of known sizes were usually used, which also allowed direct comparison of testing capability of various methods.

CCI testing methods were validated for the specific drug productpackage. Because the drug product formulation and package design may change during early development phases, a phase-appropriate approach was implemented to validate methods in concert with product development phases. For example, we utilized scientifically sound methods to support packaging system qualification and development stability studies. Once the product formulation and packaging design were finalized, the methods were then fully validated in support of primary stability and process validation CCI testing. Additional long-term method robustness may be further validated prior to implementing the method in QC laboratories for routine testing.

Figure 2. Approach to establishing Pass-Fail threshold

Summary

Appropriately selected and validated methods are essential for demonstrating container closure integrity during package and drug product development and manufacturing. However, it should be realized that current CCI testing technologies do not off er an ideal method that satisfy all prefilled syringe CCI testing needs. An integrated approach incorporating CCI testing and other engineering and administrative controls must be taken to ensure overall container closure integrity.

 

Fedegari Washing Solutions

Washer-Sterilisers (independent and combined use)

One of the most inovative solutions in the Fedegari washer range is also a unique and original. Combined Washer-Sterilisers have the ability to operate in three ways, they can be bought to be independent washing machines, operate as back up sterilisers when washing is not required or perform as a hybrid washer/sterilisers which allow you to wash, sterilise and dry machine parts, vessels and other materials in a single cycle.

 

Steam Washers

Fedegari high performance GMP Steam Washers capitalize on the experience acquired with the Combined Washer-Steriliser series within the pharmaceutical market. These machines represent a cost-effective solution for the highest performances. Fedegari steam washers use an integral steam generator to optimize performance and reduce operational costs. The state-of-the-art modular customizable rack can be adapted to every specific load configuration.

 

Free Standing Washers

The Fedegari laboratory glassware washer combines excellent washing and drying performances with first class materials, economical consumption, safety and operating ease. With its dedicated process controller and its integrated steam generator that allows steam injection directly in the chamber, this machine is suitable for use in many different applications.

 

Later this month we have prepared a special webinar broadcast with Fedegari that will focus on The Key Factors of an effective Pharmaceutical Cleaning Strategy.

For more information on the washing solutions by Fedegari, give us a call and we’ll be happy to assist you.

 

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