The Most Efficient Unit Dose Packaging Machine Available

 

 

 

 

LF of America offers their brand new PENTAFIL unit dose packaging machine that is capable of filling, sealing, and packing liquids for a variety of different industries. While LF provides contract packaging services for orders small and large and are able to create custom packaging, being part of the Internationally renowned Lameplast Group enables LF to assist companies worldwide. Our latest filling and sealing unit dose packaging machine is named the PentaFill A25. Its impressive capabilities include filling as many as 125 vials between the sizes of 0.33-1.0 ml per minute and 115 vials between the sizes of 2.0-10.0 ml per minute. As such, this efficiency is top of the market and perfect for preparing large distribution orders.
For smaller orders, we utilize a similar, comparable machine named the PentaFill A10.

For huge production lines, We would recommend the PentaFill Twin 25 that is capable to double the performance of the Automated PentaFill A25. The new Twin 25 machine is suitable for Contract filling facilities. These fillers are using injection molding technology combined with the blow, fill, and seal process to give users many added benefits. The best contract packaging companies use the flexibility and efficiency of these automated packaging systems to their advantage. The PentaFill Twin A25 is capable of matching the production output of a BFS machine thus making it perfect for contract fillers.

LF’s unit-dose and automated liquid packaging systems use injection mold technology instead of the “Blow Fill Seal” process. Injection mold technology offers companies various benefits unmatched by blow fill seal machines.

Bonfiglioli Engineering unveiled the brand new SAIL – SMART AUTOMATED INSPECTION LABORATORY for pharmaceutical applications.

Earlier today, Bonfiglioli during the opening hours of this year’s Achema Expo in Frankfurt, Germany unveiled their latest product for the pharma applications. It is capable of performing multiple in line inspections on the same package container. By design it features in line leak detection, visual container inspection and laser analysis.

To learn more about the Smart Automated Inspection Laboratory – SAIL give us a call or contact MarkoV@Lsi1.com

Bonfiglioli Engineering will be attending ACHEMA 2018 trade fair.

 

What makes this year exceptional is the world premiere of a revolutionary product in the inspection field, which will enable the pharmaceutical companies and laboratories to reach an unrivaled competitive advantage never seen before, will take place during the exhibition.

You’ll just have to come and visit Bonfig at Booth C70 – Hall 3.1 by following the “Flexible Production” indications to discover the Bonfiglioli Engineering extraordinary innovation of 2018.

More teasers of the product that will be unveiled at the ACHEMA can be found here: http://www.bonfiglioliengineering.com/news/achema-2018

 

 

Fedegari will be exhibiting their latest developments on contamination control to help customers achieving cost-effectiveness with the best performances in pharma manufacturing.

You will be able to see the integration of different Fedegari processes and technologies, as Fedegari has developed fully integrated robotized solutions for different customers world-wide helping them to achieve the best performances and increasing cost-effectiveness.

Be prepared… you will be pleasantly surprised by this exclusive Italian manufacturer, that has prepared a show that you’ll cherish forever.

For this Achema, Bruno has created an exclusive menu for Fedegari. Bruno’s special dishes express his creativity through the quality of carefully selected ingredients: just as Fedegari does, everyday, when we build our engineered process equipment.

See more about Fedegari’s show roadmap at: https://www.achema.fedegari.com/

Curious? Come and visit Fedegari in Frankfurt, Hall 6.1 – Booth B6

 

Lameplast Group, the parent network of LF of America will be settling in Hall 1.1 D48.

Lot of innovations are waiting for you: new primary plastic containers, the brand new models of Pentafill Filling & Sealing Machines, the global services dedicated to pharmaceutical industries and the newest products ready for the distribution.

A great addition to Lameplast’s services is the new filling department for sterile products with fully-automated filling and packaging lines has been opened, set in Boca Raton Florida. The eco-friendly department has been built according to the best process technologies available, and is currently being reviewed for FDA compliance. The new US based camp should be an exact copy of the Italy based contract filling facility that houses a ISO 5 compliant cleanroom, suitable for aseptic automated filling in their COC Farmaceutici plant in Modena, Italy.

LF is an exceptional company and what makes them unique on the market is the fact that they offer Product Development as part of their services. The actual in lab product development main intent is to improve the flow and specification of the product by customizing it to fit the packaging and delivery method emphasized by LF & Lameplast.

Don’t’ miss them!

 

FLEXIBLE ISOLATION TECHNOLOGY INTEGRATED TO FILLING LINES by Fedegari for BSM

 

Berkshire Sterile Manufacturing (US) can be considered the unique CMO that incorporates 100% isolator technology to the filling lines utilizing state-of-the-art equipment. This technology allows to remove the risk of human contamination from the filling and formulation process as highly suggested by FDA, EMEA and other regulatory bodies. Fedegari has proudly collaborated with BSM on engineering a cost-effective and innovative solution that helps pharma industries to advance their product candidate into the pre-clinical or clinical setting.

The result of BSM-Fedegari collaborative innovation is an isolator based filling system that is able to fill the following primary containers: bulk glass vials, pre-sterilized nested vials (glass and plastic) and syringes (glass and plastic), pre-sterilized nested cartridges (glass and plastic), and custom containers (glass and plastic). The system works with both liquid and lyophilized products and the primary containers do not have to be exposed to hydrogen peroxide before entering the isolator.

 

 

Flexible Isolation technology totally integrated to the filling lines

BSM flexible clinical scale aseptic filling system does not restricts the choice of the container and has been considered a revolutionary solution by pharma manufacturers.‘Isolator-based ‘flex’ lines capable of multiple containers have been used by some industries, but most are unable to accommodate bulk glass vials and some require previous treatment with vapour hydrogen peroxide for all primary container packaging,’ said BSM CEO Shawn Kinney.

 

‘With this project BSM is definitely one of our most forward-looking customers. I hope that the experiences we are doing together will enable pharmaceutical manufacturing to reach new efficiency standards’ commented Giuseppe Fedegari, President of Fedegari Group.

“We are pleased to provide to our clients and our future clients the best available technology for their sterile manufacturing requirements”, stated BSM CEO Shawn Kinney.

 

BSM COMPLETES VALIDATION OF STATE-OF-THE-ART ISOLATOR

Berkshire Sterile Manufacturing (BSM) has just completed the installation and qualification of its Freeze Dryer IMA Lyomax 3 connected to BSM’s Fedegari Isolator Line. The last step to complete this innovative project will now provide BSM clients the highest levels in sterility assurance. The qualification involved extensive IOQ’s of the equipment, validation of the SIP and CIP and media qualifications that utilized three complete loads. The validation involved BSM’s Colanar Flexible Filler, capable of filling vials, syringes and cartridges on the same line. BSM completed the isolator qualification with over 12,000 units/run in triplicate with filling duration’s of over 60 hours per run.

CUTTING EDGE TECHNOLOGIES GUARANTEE COST-EFFECTIVENESS

The Berkshire Corporate Center (US) is equipped with cutting edge manufacturing technologies – including Fedegari process equipment – such as isolators, flexible sterile filling equipment, modern cleanroom and terminal steam sterilization capabilities to manufacture sterile drugs.

BSM’s Fedegari autoclave, for example, has the capability to terminally sterilize syringes, bags, vials and ampules with a 20,000 unit load capacity. The autoclave has internal heat exchangers that can be used to warm the chamber by putting steam through prior to starting a cycle. This eliminates the condensation that normally occurs on the walls of the chamber during standard heat up with common autoclaves in the market.

 

To speed up turnaround times BSM’s autoclave is also equipped to use the heat exchangers with cold water to cool the load while pulling vacuum to dry the load. Less condensation of steam increases efficacy of the sterilization process while also reducing time of the product or equipment in the autoclave.

 

The complete data of the case study and a photo gallery showcasing Fedegari’s latest Isolation technology can be found here: https://www.fedegari.com/en/berkshire-sterile-completes-validation-of-flexible-isolator/

 

FINISHED PREFILLED SYRINGES INTEGRITY TESTING METHOD DEVELOPMENT, VALIDATION AND 100% IN-LINE HIGH SPEED SOLUTION

 

The application of Vacuum Decay Method for 100% In-line high-speed Container Closure Integrity Test to pre-filled syringes is a technological innovation that allows pharmaceutical companies to increase their quality assurance for sterility and stability. Main reasons are linked to the high control given by such a very sensitive tool to identify possible leakages linked to imperfect assemblies and pinholes that also gives the possibility to be validated in a simple, reliable and repeatable manner by means of calibrated leakers. An established technology, based on ASTM standard F2338, FDA consensus standard since 2004, applied on most pharmaceutical containers can now be used also with high performances in terms of throughput and sensitivity for PFS’s.

 

Prefilled syringes have become very popular in pharmaceutical industry as a parenteral drug delivery device, in fact, many are the benefits of this format including eliminating dosing errors and reducing accidental needle sticks by hospital staff. Since its introduction, several methods have been developed and applied for the performance of Container Closure Integrity Test (CCIT), both as in process control and in line.

Stringent requirements from the industry have brought to the development of different technologies and implementations by pharmaceutical companies both as in-process control and as in-line control; up to now all the available methods presented limitations either from the aspect of 100% usability or from the aspect of reliability.

The innovative technical solution, here presented, which utilizes Vacuum Decay Method, compliant with the ASTM F2338 “Standard Test Method for Non Destructive Detection of Leaks in Packages”, recognized as a Consensus Standard by the US Food and Drug Administration is able to perform a reliable and efficient CCI test in a 100%high speed in-line pharmaceutical manufacturing environment.

Vacuum Decay Method is included, just like Electrical Conductivity and Capacitance, Laser-Based Gas Headspace Analysis, Mass Extraction, Pressure Decay and Tracer Gas Detection, in the list present in USP between the suggested deterministic leak test technologies. Being this the most up-to-date reference that clearly suggests pharmaceutical world to move towards this type of methods instead of probabilistic ones more commonly used, such as Microbial Ingress or Dye Ingress. It also specifically addresses the maintenance of the microbiologically integrity of sterile product packaging until the time of use of its contents, by defining:

  • Package Integrity Testing in the Product Life Cycle.
  • Test Method Selection Criteria.
  • Test Instrument Qualification, Method Development, and Method Validation.

The limits of the dye ingress test method, for example, like high risk of inaccuracy and above all its being a destructive procedure, have been largely eliminated thanks to the development of non-destructive techniques, limiting this traditional method to In Process Control and lab procedures.

 

In particular, when dealing with PFS’s, the CCI testing is performed while the PFS itself is held within a hermetically sealed test chamber, connected to external vacuum source and designed to minimize residual volumes. Once the test chamber is loaded, the VDM process comprises 3 phases:

  1. a) Vacuuming: the period of vacuum setting within the test chamber
  2. b) Stabilization: the time necessary to get a homogeneous vacuum distribution within the test chamber
  3. c) Testing: the time frame in which the vacuum level is monitored by means of a dedicated transducer.

During testing, two measurements are taken respectively at the beginning (1st reading) and at the end (2nd reading) of this phase in order to compare the vacuum decay delta (“Δ”) to a predetermined threshold (THR).

 

 

The advantages of VDM include:

  • Complying with a FDA consensus standard.
  • Being applicable to most package systems.
  • Being able to test the overall package systems.
  • Being reliable and repeatable.
  • Including a barometric compensation system.
  • Being convertible: it can test vacuum or pressure without need to change any components.
  • It’s a technical solution capable of prevent syringe stopper movement.

But there are also some disadvantages, such as being not appropriate for proteinaceous or highly viscous content that can be, in some cases, cope with using Pressure Decay Method instead.

 

A more comprehensive showcase on the machinery that carries out vacuum decay testings, is available in this webinar that we recently broadcasted.

<iframe width=”620″ height=”348″ src=”https://www.youtube.com/embed/uj-VuatCh90″ frameborder=”0″ allow=”autoplay; encrypted-media” allowfullscreen></iframe>

 

This article was created by Giovanni-Benedetto Golinelli and was initially published in the latest issue of PHARMA HORIZON magazine [vol. 2(2) 2018]. You can download the full article here: http://www.bonfiglioliengineering.com/uploads/files/Golinelli_PH2.pdf

 

MesaLabs Manual Cap Torque Analyzer

 

The Sure Torque Series of Manual Cap Torque Analyzers are designed to measure application and removal torque of bottle caps up to 50 lbFin [5.65 Nm]. They feature adjustable posts that effectively grip a broad range of container shapes and sizes, while optional flat and adjustable jaws are available for unique profiles.

The ST-H0X Manual Tester is recognized by its rugged aluminum design, and simple, intuitive operation allow for use in laboratory and production environments.

Mesa Labs’ Manual Cap Torque Testers are known for their class-leading accuracy of ±0.3% and blazingly fast sampling rate of 7,000 Hz which ensure reliable and consistent test results, even in quick-action applications.

The ST Series includes a range of sophisticated productivity-enhancing features, including USB, RS-232, Mitutoyo, and analog outputs, automatic data output and zeroing upon cap removal, memory storage for 1,000 readings, pass/fail indicators and outputs, and more.

Password protection is provided to prevent unauthorized changes to settings and calibration.

The ST Series of analyzers include MESURTM Lite data acquisition software. MESURTM Lite tabulates continuous or single point data. Data stored in the unit’s memory can also be downloaded in bulk.

Another important aspect of this product is the one-click export to Excel for further data manipulation, which makes the ST-H0X compliant with the FDA 21 CFR Part 11.

Interested in seeing this equipment or other torque testers in action, please get in touch with our regional representatives and we’ll get you on our agenda.

 

Bonfiglioli at IPACK IMA 2018

At the upcoming tradeshow, the IPACK IMA 2018 in Milan, Italy starting tomorrow May 29 Bonfiglioli Engineering will present their innovations in leak detection machinery. The Bonfiglioli Engineering range of non-destructive machines offers 100% Inline and offline leak detection for bottles, doy packs, food cans, ready meals and stick packs using Force Decay, Lid Deflection Vacuum and Pressure Decay methods. Solutions are available also for Automatic Visual Inspection of containers and Headspace Gas Analysis for MAP Packages.

Bonfiglioli’s products have broad applications and are huge contributors to the ever improving food safety challenge. This package integrity validation technology has been developed by Bonfig to address the growing need of the industry to validate the integrity of a package prior to food packing. Initially, the focus was on hot dog and sausage packages, but updated regulations are now being targeted to several other package formats, including bacon, sliced meats, cheese, and other forms of vacuum formed packages.

Leak detection machinery is not a simple technology, but a combination of various technologies dependent on the requirement. Vacuum, vision, and several other sensor technologies can be integrated to detect seal contamination, leaks, pin-holes, and other elements leading to loss of package integrity.

Food package inspection is typically a pass/fail selection, but in some cases such as the FDA 21 CFR Part 11, statistical information can be gathered and reported to determine online or offline process improvements. Rejected packages are typically not packed and flow through the system into totes or exit conveyors.

 

Stop by Bonfiglioli’s booth HALL 5 – BOOTH C17 at the IPACK expo at Rho Fierro Milano if you happen to be touring across Europe or contact us if you need help to solve your food packing integrity needs!

Secondary Packaging Conveyance

 

 

Secondary packaging mainly for palletizing purposes includes packed items such as bundles, trays, bottle/cans packs, cartons, crates and bags. For the handling of bigger and heavier loads such as pallets or steel structures. Vetromeccanica offers tailored solutions in order to satisfy most demanding customers’ requests.  Vetromeccanica are famous for their complete conveying lines that include various modules for elevating, dividing, cooling, turning and tray forming.

Vetromeccanica utilizes an approach where each specific installation requirements and peculiar package features are determined on a case-by-case basis so that they come up with the technical requirements of each conveyor system needed to transfer each package in the best way.

Vetromeccanica’s secondary packaging conveyors work with any type of pack (shrink-wraps, carton boxes, crates, trays) customizing layout and production speed. Stainless steel is used as required by the hygienic design of each machine.

Vetromeccanica are specialist in automation systems for high-speed conveying lines for containers. As such it believes in the continuous development of line automation, an information network that transforms a group of machines into a high efficiency plant. The automation systems feature speed modulation using inverters (installed in the remote power board or near-field) to reduce power consumption and noise. The Syncro system in addition to the electrical and electromechanical control devices are used to optimize installations that have a high concentration of inputs and outputs.

 

For more information on the complete gamma of conveyance solutions developed by Vetromeccanica please contact us and we’ll let you know when will our next conveyance week is going to take place.

 

 

Differences Between Injection Molding & Blow Fill Seal

Injection Molding Technology + Fill & Seal

  • Two-step process that molds vials then transfers them to the filling line to be filled and heat sealed. (No risk of contact between product and heat)
  • Added flexibility that ranges from small batches at 1,500 vials per hour to full-scale production at 15,000 vials per hour.
  • Smaller dimensions mean machines fit in most existing contract filling environments.
  • Improved end-user experience. Easily switch out or replace damaged, worn, or old parts.
  • Less than half of the cost of traditional BFS machines with the same production capacity.
  • More environmentally friendly and no excessively wasted plastic material.
  • Provides the option for multilayer packaging designs and calibrated drops.

Blow Fill Seal (BFS)

  • One-step process that blows and fills vials at the same time. (Risk of contact between product and heat)
  • Only capable of full-scale production at roughly 10,000 vials per hour without being able to stop the machine. 3 working shifts necessary once started.
  • Large dimensions with a recommended minimum room size of 500-600 square feet.
  • Halted production time due to the changeover of molds.
  • Higher initial financial investment and overall cost.
  • Large amount of plastic waste is cut from the parison and then disposed of.
  • Extremely complex set up, maintenance, and operating instructions that require highly skilled and well-trained personnel.

LF of America uses the most advanced contract filling equipment to fulfill orders big and small. They also manufacture the Pentafill innovative liquid packaging machines and distribute the most highly advanced contract filling equipment available. These unit-dose and automated liquid packaging systems use injection mold technology instead of the “Blow Fill Seal” process. Injection mold technology offers companies various benefits unmatched by blow fill seal machines as shown in the bullet points above.

 

To request a free product sample or to speak with one of our team members about packaging services or manufacturing contract filling equipment contact our representatives.

Bahnson Standard Reach-In Chambers

The Bahnson ES2000 reach-in stability chambers is provided in four standard sizes, ranging from 12 to 144 cubic feet, each offering a wide variety of temperature, humidity, and light (photostability) capabilities.

 

Bahnson Environmental Specialties’ typical reach-in chamber uses include ICH stability, shelf life studies, photostability (ICH Q1B Option 1 and 2), incubators, plant growth, tissue culture storage, freeze-thaw, blast freezing, and other product testing and/or stability storage.

Chambers can also be designed to meet classified storage requirements (Class 1 Div 2), HEPA filtered cleanroom standards (Class 100-10,000), cycling/stress test requirements, or other special design requirements on request.

BES offers a range of environmental test and stability chambers designed for high demand testing, processing, conditioning, or growth applications.

The ES2000 product line includes six standard models. Standard temperature capabilities range from 2° C to 70° C, with controlled humidification, lighting and CO2 available.

A 13-month warranty on parts and labor is included with all ES2000 stability chambers. An optional five-year compressor warranty is also available.

More info about the ES2000 can be found on Bahnson’s website: http://www.eschambers.com/products/standard-reach or by contacting our representatives.