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.

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.

 

Setting up a pharmaceutical cleaning strategy

Cleaning is an essential practice for any pharmaceutical activity. Difficulties can arise from the fact that the concept of ‘clean’ is not easily defined or can be related to non-evident residues.

 

Defining differences between sterilization and cleaning treatments, for example, is important to understand in-depth the main problems and peculiarities when setting up a cleaning strategy.

 

The kinetics of ordinary sterilization processes are well understood: to sterilize means to destroy or inactivate microorganisms. In this perspective, we know the target and we can define it in terms of a number (CFU/unit) and resistance (D, z). Though the definition of sterile product/ item is probabilistic (PNSU – Probability of Non-Sterile Unit or SAL – Sterility Assurance Level), it is universally accepted.

 

On the other hand, for a cleaning process, the “enemy” is not defined and, in any case, can vary on a case-by-case basis: residue of previously processed product, diluents, solvents, lubricants, microorganisms, etc. There is no absolute definition of cleanliness. The kinetics of the cleaning procedure are unknown. Consequently, also the definition of “cleaning dose” to be provided is undetermined.

 

In these conditions, even regulatory bodies struggle. Essentially, they allow manufacturers considerable flexibility in establishing their own cleaning specifications. The FDA, for example, does not define methods describing how a cleaning process should be validated. FDA inspectors have to assess the rationale used to set the cleaning limits, making sure that their basis are scientifically justifiable and grounded on adequate knowledge of the materials involved.

This is the reason why Fedegari have published a new e-book: to discuss the main challenges on taking the right decisions while developing a cleaning strategy. New requirements have been faced by manufacturers, new targets have been fixed and the evidence that these are met is shown through successful case studies. Our aim was to highlight the best practices and existing solutions to support your decision-making.

This is certainly a multidisciplinary issue that involves various company areas: from “Regulations” to Engineering, from Quality Control lab to Production department. Fedegari have collected contributions of all these areas together in order develop a robust and repeatable cleaning process.

In their new E-book you will find:

  • Aspects Distinguishing a Cleaning Process
  • Steps for Setting Up a Cleaning Procedure
  • Case Study I: Removal of Bacterial Endotoxins
  • Case Study II: Application of a Washer Sterilizer
  • Case Study III: Soil Removal From Smart Plate

 

Download it here for free. If you want to discuss your cleaning strategy with us give us a call at 800-829-5741.

 

 

FOWS The power of steam: a cost-effective cleaning

 

 

 

Fedegari Lab Division latest innovation is a Lab Glassware Washer that capitalizes the experience done with FOWS-series of washers in the pharmaceutical industry.

 

The new FGW Lab Glassware Washer uses a steam generator to improve washing performances: steam has an optimized emollient effect on greasy and sticky dirt.

Moreover the use of steam can significantly reduce operating costs: this true eco-friendly solution allows to minimize the need of detergents as well as water consumption, lowering the running costs per cycle. In addition, steam is able to access hard-to-reach areas and therefore clean thoroughly. A conductivity meter placed on the FGW drain is capable to detect the water purity, helping to terminate the process as soon as the desired set-point is reached thus further reducing water and other utilities consumption of the washer.

The cleaning process is constantly supervised:

  • Dedicated probes monitoring the temperature of the air/water and of the steam in chamber
  • A dedicated trasducer controls the pressure of the circulating water.

 

Fedegari Glassware Washer has an internal LED lamp that remains operative during the whole cycle: in case of alarm evident signals are displayed by color change.

 

The piping, as any other equipment manufactured by Fedegari, has a rigorous sanitary finishing. The machine is loaded by a modular rack which could be standard or customized for adapting to all loads configurations and is directly connected to the piping.

 

As all Fedegari laboratory process equipment, the FGW is easy to use specially thanks to ergonomic loading height, a friendly process controller and the interchangeable external trolleys compatible with Fedegari FOB5 lab sterilizers.

 

As all Fedegari lab equipment, the FGW series is compliant with cGLP standards.

The FGW series is equipped with Thema4lab process controller, engineered and pre-validated by Fedegari according to GAMP5. Thema4lab is the most advanced process controller for lab applications, based on a wide library of phase groups, developed by Fedegari thanks to its experience with the highest standards in the pharmaceutical industry.

Having doubts about the Thema4, please see this podcast we did a couple of months ago for our Lunch and Learn Webinar Series.

 

On demand you can also integrate the FGW Lab Glassware Washer with your FOB5 Horizontal Steam Sterilizer.

 

For more information on this or any other Fedegari products please give us a call 800-829-5741

Complete Production Line by Cozzoli

On specific client demand, Cozzoli has developed a complete production line that houses Filler, stopper, capper and unscrambler. The complete production line was installed at Biocor in Omaha, Nebraska. This is a very comprehensive production line solution since it meets all the FDA regulations regarding vaccines for veterinarian use.

 

OPERATIONAL LINE SEQUENCE:

Containers are placed on the unscrambling table, where they are automatically fed into the filler infeed conveyor. The containers are allowed into the filling station by a gating device, adjustable for different container sizes. After completion of the fill cycle, filled containers travel to the RS400 Stoppering Station, where full stopper insertion occurs. After stoppering, containers then travel to the CM200 Crimping Station, where aluminum crimp seals are adhered.

 

Containers enter the filling machine via the gating device and are filled using the diving nozzle system. The VR840 is a positive displacement liquid filler, operating on a 4″ pump stroke. This filler is equipped with a total of 8 stainless steel syringes for fill volumes up to 600 ml, and speeds up to 120 bottles per minute. After the fill is complete, containers cycle out of the filler and enter the Stoppering System.

 

BioCore’s RS200 Stoppering System is comprised of a vibratory sorting bowl, stopper feed chute, container feed screw and stoppper pressing foot. This machine is stoppering three container sizes with 20mm and 30mm stoppers. Sensors are located on the stopper chute for stopper make-up and on the conveyor for container make-up and back-up.

Traveling down the conveyor, the filled and stoppered vials are captured by an infeed starwheel for entry into the CM200 continuous motion rotary crimping machine. This machine also has a vibratory bowl; orienting the aluminum caps for placement into the feed chute. As the stoppered containers pass underneath, the containers strip-off the aluminum cap as it enters the infeed star wheel. The container then passes into the main star wheel, where the crimp head lowers. Contact with the cap activates the crimp head rollers to begin the progressive roll seal process.

CRIMPING OPERATIONAL SEQUENCE:

A fixed cup is used in each crimp head to prevent rotation of the container, and the crimping skirt height is easily adjusted for each size crimp. An automatic vial height adjustment is included with this machine for ease of container changeover. Simply place the container on the height gauge, and the height is measured and corrected automatically on the crimper. This machine will crimp 20 and 30 mm seals.

ACCUMULATION TABLES by Vetromeccanica

Accumulation is required in high speed production lines to make sure that the generating unit continues to run during malfunctions of downstream equipment.

Simply stated, if the generating unit is idle, the production is lost forever. Further, a certain amount of products or packages can be damaged during the stop and start cycles. Often manpower is utilized to unload product and then re-load the product back into the production flow.

A reliable accumulation system results in more production, less waste and decreased manpower. Vetromeccanica develops custom made solutions applicable to unique circumstances and production lines. The Accumulation Table utilizes a recirculating design that relieves back pressure, allowing for smooth, jam-free single filing of products through the discharge.

Vetromeccanica strives for limiting the footprint of the table which in their case is relatively small compared to the accumulation table’s storage capacity

If necessary Vetro can easily customize the standard accumulation setup to Bi-Directional Feed Table, that randomly discharges accumulation. Featuring automatic cycling, a sweep bar can be added to the system to provide automatic and complete unloading of product.

When a line stop occurs, the table’s belt is controlled to move at a right angle to the conveyor line, and begins loading. When downstream blockage is clear, the belt reverses for unloading thus making this solution best fit for unified packaging of different products. This conveyance solution is highly demanded within high level production lines that perform filling all kind of liquids into packaging in the chemical, pharmaceutical and food & beverage industries.

 

 

For more information regarding conveyance systems and accumulation tables please get in touch with us. 800-829-5741

TAMPER EVIDENT LABELLING SOLUTIONS

 

The Falsified Medicines Directive (FMD) 2011/62/EU will come in to force by February 2019. This directive requires two mandatory safety features that will enable medicines to be verified and authenticated along the supply chain:

  • Tamper evident features on the carton
  • A unique identifier (2D data matrix code and human readable information) on the carton

Newman’s range of automatic tamper evident labellers enables our customers to meet these new regulations, whilst also providing high levels of flexibility, quality and reliability. Designed to apply a range of self-adhesive tamperevident, anti-counterfeit and hologram labels, a single machine can handle a wide range of carton types and sizes without the need for change parts.

  • The CTE350 is a tamper-evident labeller that operates at speeds of up to 350 cartons per minute and, measuring just over 1m in length, is ideal for integrating in to lines where space is at a premium.
  • The CTE450 operates at speeds of up to 400 cartons per minute and, with track and trace serialisation capability, meets the requirements of the Falsified Medicines Directive.

Specifically designed for healthcare applications, the CTE350 and CTE450 have a stainless steel/GMP construction and are available with full Validation Documentation Package. In addition, Newman Labelling Systems is able to integrate different print and inspection systems to meet our customer’s specific requirements.

As a design and manufacturing company, Newman thrives on the challenges that our customers bring to us! If you have a specific labelling requirements then please let us know at 800-829-5741

AUTOMATED ISOLATOR WITH ROBOTIC ARM

It is no revelation to say that the age of robotics and automation is underway, as many assembly line industries have utilized production robots in one form or another for several decades. Yet pharma manufacturing remains heavily human. Robotic systems, however, can offer solutions to problems caused by the human element, such as the problem of microbial contamination in aseptic processes.

In a presentation at the Nov. 2014 PDA Parenterals conference in Munich, Germany, Sergio Mauri, Manager, Integrated Projects Business Unit, Fedegari Autoclavi, showcased his company’s gloveless, fully sealed isolator that uses a robotic, GMP-compliant arm. This solution is currently in an advanced development phase and the company hopes to market it for small-scale manufacturing of personalized, cytotoxic materials used for clinical trials.

 

If we are able to take personnel out from our process, then we will really reach the goal to have an advanced aseptic process,” he said. “The isolator with the GMP robot can give a flexible and modular solution.
He added, “Our system is based on a batch system and it is completely sealed.With no operator required, the isolator supports a completely automated fill/finish process. Without the need for gloves and the resulting glove ports and gauntlets, a greater level of sterility assurance is assured.

 

The equipment includes Wash in Place (WIP) capability to clean the contamination generated by the process. It also uses single-use material such as ready-to-use primary containers and closures, beta bags and disposal waste bags.

 

To ensure airtight construction, Fedegari’s seven-axis robot arm—built by robotics manufacturer Kawasaki—is stainless steel and designed to be low particle shedding. It is also resistant to high pressures and temperature wash downs, fully compatible for decontamination using H2O2 vapors. The system can also support both positive and negative pressures. An electronic motor controls the strength of the arm’s grip.

 

This is really a breakthrough,” emphasized Mauri.

 

External parts are decontaminated with steam sterilization. The tubs inside the isolator are decontaminated with H2O2 through a vaporizer that controls a dosing pump and heater for compressed air by means of saturated steam within the material transfer autoclave before entering the isolator.

 

Human Element Still a Factor

Fedegari, according to Mauri, is currently wrapping up development of the isolator. One company has already signed on to purchase the isolator and Mauri expects others to look into the system. He stressed that “nothing is advanced with human intervention,” and the company seeks to remove the human element from the aseptic environment except for loading and unloading the isolator.

 

Yet other industries have seen issues—and even crises—arise from becoming fully reliant on automation. In fact, overreliance on automated systems has been cited as a major factor in the 2009 crash of an Air France flight (1). In a separate interview with the PDA Letter, Mauri acknowledged this could be a potential risk. He said he would encourage a customer to use the Quality by Design approach to build a risk assessment regarding an operator’s ability to correctly respond to the equipment. It is part of training, part of making all the safety requirements in devices in order to avoid problems due to a lack of control by the operator,” he said.

 

While the isolator system is currently configured just for small-scale production, Mauri does see the potential for use in larger-scale manufacturing, particularly if manufacturers move to using smaller, parallel systems.

 

We have to take an example from semiconductor manufacturing where they have a huge manufacturing output by adding in parallel, smaller clusters. So, even if one of these clusters is running out of operation there are another 50 working giving out all the outputs. While in pharmaceutical manufacturing, with big-scale manufacturing we have a line, and if the line is jammed and it stops for two or three hours, you are losing the production of two or three hours,” he explained. “We have to learn from other businesses how to manage the efficiency of the pharmaceutical industry.

Vetromeccanica at Pack Expo

Vetromeccanica S.r.l. – Conveying Solutions Attending Pack Expo

 

Specialized in conveyors and accumulating tables for loose and packed containers, make sure to connect with Stefano who will provide details on their fleet of Conveying systems. VetroMeccanica also offers conveyors for products which require a specific and more tailored design.

Vetromeccanica Srl has been engineering and producing bottles conveyors since 1992.
Starting as a glass bottle conveyors manufacturer Vetromeccanica has been continuously extending its field of expertise and in the ’90 became one of the world leader manufacturers of air conveyors for PET bottles.
The company offers nowadays a comprehensive range of conveyors for both primary and secondary packaging. Conveyable products go from yoghurt cups to toothpaste tubes varying from beverage, food and chemical industry.

 

Stefano Lodi, Vetro Meccaninca Business Development Manager will be in Attendance. Contact Stefano beforehand to schedule a meeting and discuss projects concerning Vetro Meccanica product line by emailing him: s.lodi@vetromeccanica.it

 

Contact Stefano Lodi and set up a time and date for a meeting since his schedule is very tight.

 

If you want to discuss other conveying solutions that we can help out with, please call 800-829-5741 and let us know what we can do to help you out.

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