Testing oxygen and moisture levels in containers

Did you know that Headspace Gas Analysis is a great solution for testing oxygen and moisture levels in containers for:

  • Viscous liquids with a high boiling point or insoluble components, such as blood, paint, or adhesives.
  • Insoluble solids
  • Lyophilized products
  • Aroma components from food and beverages

Bonfiglioli provides custom-built solutions for your Headspace Gas Analysis requirements.

They range from the quirky little Laser Cube Tabletop machine all the way up to In-line fully automated Integrity Inspection System for performing Headspace Gas Analysis (HGA) of sterile pharmaceutical containers.

Headspace Gas Analysis (HGA) inspection process based on the Tunable Diode Laser Absorption Spectroscopy (TDLAS) method to accurately quantify gaseous concentration levels. Diode laser beam transmitted through headspace region of the container and reflected back towards the receiver. LVA 600 sensors measure the laser beam absorption related to target gas concentration.

Not dependant on the size of the equipment, Bonfiglioli solutions are able to perform the following:

  • Nitrogen purging not required
  • No reference container required during operation
  • Easily upgradeable
  • High Versatility to achieve customizable solutions
  • Automatic container rotation ensures highly accurate test results
  • Extreme stability and accuracy even with limited headspace
  • CFR part 11 compliance and 4.0 full integration

Contact us today to learn more about Bofiglioli’s Head Space Gas analysis solutions.

LF of America Dual Chamber Bottles

Need to mix two different products just before application? LF of America Dual Chamber bottle with reservoir is your answer.

This dual-chamber bottle allows for liquid + powder products to be placed in the same container. This unique container also features a tamper-evident cap.

Here is how it works: the 10 mL bottle and 1.5 mL reservoir provide separate storage of two different products.

Applying pressure on the top of the cap, the internal membrane is perforated and allows the contents of the reservoir to flow into the bottle. The two products can now be mixed together right before use.

Contact us today with any questions you might have.

Ultra-Low Temp Freezer

Bahnson’s popular Low Temp Walk-In Suite (LTW) utilizes an innovative chamber-within-a-chamber design to support the stringent biorepository and pharmaceutical requirements for ultra-cold temperature storage freezer vaults. It offers a more energy-efficient alternative to the traditional “freezer farm” approach, while still delivering maximum capacity, multi-temperature storage flexibility, and product protection.

Each suite is custom designed to your explicit size, temperature, and electrical-controls specifications. Additionally, the LTW utilizes multi-door vaults that are capable of temperature setpoints of -60, -70, -75, or -80°C— located within -20 to -40ºC freezer corridors—that are designed to share a central cascade refrigeration system.

This suite is ideal for biopharma production and biorepository applications. With the flexibility of product storage containers, including bottles, plates, small vials, bulk drums, and canisters, the LTW offers multi-temperature storage for a wide variety of products, including samples of drugs and various biological products.

Energy Efficiency and Cost Savings

Our ultra-low LTW freezer suite offers a significantly lower chamber count and as much as a 33% reduction in building space when compared to a “freezer farm”.

Saving hundreds of thousands of both kWh and pounds of CO2 emitted annually,  the BES solution can offer a 75% reduction in total energy consumption.

The result is an economical, space-saving product line that combines maximum capacity, multi-temperature uniformity with energy efficiency and cost savings.

Bahnson Environmental Specialties’ low-temperature freezers give you high-performance operation, significant cost savings, and greater dependability than ever before. Contact us to learn more.

Eliminate the variability of cap rotation

Automated torque testing eliminates the variability of all four key process variables cap rotation, top load, bottle clamping, and cap gripping pressures.
Mesa Labs torque testers simplify and automate data management and comply with 21 CFR part 11.
Customize the test method and alarm limits to the process variable specifications in your capping.
Eliminate universal tooling variability with our customized torque engineering design services.

Maximize up-time on your automated torque tester leveraging Mesa Labs on-site torque service capabilities.
Why choose Mesa Labs?

  • Mesa’s ISO 17025 accredited calibration lab can send a technician on-site to calibrate your torque equipment.
  • Our dedicated validation engineer provides customized factory acceptance testing and Installation/Operational Qualification protocols.
  • Comprehensive technical support available online, over the phone, and on-site.
  • Mesa torque testers are calibrated to ASTM D3474-90 standard using NIST traceable dead weights and the dynamic Gold Bottle torque verification standard.
  • Digital storage of calibration certificates for audit and traceability.

Download the white paper on variability in torque testing by filling out the form on this link https://info.mesalabs.com/torque-beverage-bottling

Mario Negri Institute FOWS Case Study

The Challenge

Design and deliver a complete cost-effective solution for washing and sterilizing animal cages with full backup of all process equipment. Use the equipment process chambers as chemical decontamination pass-through.

Project requirements:

Washing and sterilization of:

– 3.000 animal cages (metabolic and green line) of different sizes and relevant accessories per week

– Cage lids and grids, once/twice per month

– Animal food packages, as needed

– Sawdust packages, as needed

– Feeders, as needed

Chemical decontamination of:

– Various heat-sensitive instruments and items Max cycle time: 100 min

The Customer

Mario Negri Institute for pharmacological research is a not-forprofit biomedical research organization structured on four research centers in Italy (Milan, Bergamo, Ranica and Chieti), a foundation in the US and employs about 1.000 personnel, mostly researchers. The main fields of activity are the battle against cancer, nervous and mental illnesses, cardiovascular and renal diseases, rare diseases and the toxic effects of environmental contaminants, mother and child health. Mario Negri Institute and Fedegari have been collaborating for decades and in 2007 Fedegari has been awarded the contract for supplying two FOWS washer sterilizers for the new research facility in Bergamo.

The Solution

Installation of two FOWS washer sterilizers side-by-side capable of washing, sterilizing and drying various types of animal cages in one single process. The machines are equipped with different rotating and static spray nozzles located on the sterilization chamber walls as well as on the racks, so as to cover all load surfaces. No manual operation is needed to connect the rack to any water feeding system; a simple maintenance-free auto coupling ensures the water flow through the rack. The same device also allows feeding steam through all the nozzles for improving cleaning performances in a way no traditional washer can do.

Cycle duration is approximately 100 min, considering 20 min for the wash/rinse phase and 20 min for sterilization. The water consumption for this application is approximately 250l each process. Like a typical steam sterilizer, drying is performed with a vacuum after sterilization, thus avoiding the use of HEPA filters.

Due to the specific requirements, both machines are equipped with a vaporized H2O2 generator for decontaminating those heat-sensitive items that need to be transferred inside the animal holding room. With this solution, it has been further reduced the number of machines installed and the relevant acquisition and operating costs.

Newman Easiplice 470 Labeling System

An aspect of self-adhesive labeling which often gives cause for concern is the loss of production time incurred by label replenishment. Such losses become increasingly significant as machine speeds increase – more frequent reel change-overs result in more production downtime.

The Easisplice overcomes this concern by enabling reel change-overs to take place with no interruption to the supply of labels to the label head.

The Easisplice is supplied as a free-standing unit complete with an angled twisting bracket.

Operation

The Easisplice unit holds two reels of labels – one acts as the current label supply while the other is positioned to facilitate rapid splicing. A microprocessor control unit working in conjunction with photoelectric cells ensures that a constant buffer stock of labels is available in the buffer bin to the labeling machine.

As the current label reel nears its end, a flashing beacon alerts the operator, who triggers the reel to fully dispense into the buffer bin.

The end of the label reel is automatically detected on the splicing table, signaling the Easisplice to stop. The second reel is manually spliced whilst labeling continues using the labels in the buffer bin. Once the splice is made a reset button is activated and uninterrupted labeling continues

Contact LSI today to receive more information, technical specs, and the latest pricing on these machines.

The all new Bench-top Pentafill® L+Fill

The Pentafill® L+Fill is a Bench-top machine for filling and sealing single-dose plastic containers.

This Bench-top machine is suitable for lab research and small quantity start-up production that meets the same industrial sealing standards as higher capacity Pentafill models.

Whether you are looking to complete laboratory studies, or produce small start-up quantities of single-dose plastic vials, the Pentafill L+Fill allows you to mimic the results of industrial production in a compact, bench-sized sealing machine.

• Machine includes a heating head, cold-molding pliers and a sealer

• Strip holder requires manual movement

• Interchangeable holders for different containers capacities

• Simple external controls

• Pentafill supported formats: 0.33 – 0.6 – 1 – 2 – 3 – 5 – 10 ml

For additional information, please contact our representatives.

Universal Torqo Chuck

Torque analyzers are customized for the specific bottle and cap combination to be used on the unit. Chucks are most often designed to match the serration patterns of each cap resulting in additional change parts, complicated changeover processes and greatly increased cost to the end-user.

As an increased variety of closure designs have gained prominence and popularity in the industry, Mesa Labs has developed a new Universal Chuck to accommodate multiple serration patterns and capsizes with a single change part.

Features

• Fits any Torqo model 1502 – 1600 torque testers

• ROPP cap compatible

• Tapered fit to accommodate most 26–32mm OD caps (CR, CT, TEB, etc)*

• Compatible with various serration patterns

• Eliminates the need for multiple chucks

• Non-destructive (does not leave marks when used properly)

• Compatible with smooth caps (torque limitations apply)

Contact us today for pricing info or to inquire about universal chuck designs for other cap OD ranges.

Leak inspection is fundamental for the pharmaceutical industry

Vacuum Decay method for leak detection of Pre-filled syringes has proven to be an effective method of testing. In this application note, we demonstrate the benefits and its application to better understand how the technology works. The Vacuum Decay testing method is based on ASTM F2338-09* for leak testing containers which are a recognized consensus standard by the FDA and are included in the list of Deterministic Leak Test Technologies of USP General Chapter.

Tested products:

▪ Carpules,

▪ Injection Devices,

▪ Pre-filled Syringes.

BENEFITS

Testing to prove containers integrity for proper sealing and absence of any product leak after packaging ensures pharmaceutical companies’ compliance with regulatory recommendations in the use of a deterministic test method for sterility and stability. Employing a non-destructive method allows for repeating tests also at different times, in order to validate the packaging assembly and components stability; it can also be a good business practice as an in-process control to ensure robust control of the package container closure integrity (CCIT).

APPLICATION FIELDS

The technology allows end-users to ensure efficient and productive manufacturing and packaging while also meeting safety requirements, authorities’ regulations, and market quality standards. The possibility to integrate the technology into different types of machines allows for its application to the various stages of the package lifecycle. This kind of flexibility helps the client to apply it to small scale testing as well as to 100% in-line testing.

TESTING TECHNOLOGY

The Leak Test takes place in an airtight Testing Chamber in which a pressure differential is applied (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 the test period. The test will result in a Pass, Fail Gross, or Fail differential pressure (ΔP) outcome, and will be displayed on the Human Machine Interface (HMI) screen. The high reliability and reproducibility of the method allow determining in a few seconds the integrity of the tested container.

AIM OF TECHNOLOGY

Bonfiglioli Engineering lab appliances and automatic machines have been successful in testing for critical defects in individual containers. The technology has been used and implemented for several applications with different types of Pre-filled Syringes, Carpules and Injection Devices, speed, and leak requirements. We offer excellent test capabilities for those looking for machines ranging from small manual units to 100% in-line solutions. Bonfiglioli Engineering test appliances have a long record as a proven non-destructive test method with a fast ROI compared to traditional destructive test methods such as blue dye and microbial ingress testing. Bonfiglioli Engineering solutions take advantage of electronic and pneumatic components state of the art which are a common factor between the entire range of testers for Lab, off-line and in-line applications. This allows end-users to utilize the same test method from the early stages in the lab, through clinical trials and into full-scale manufacturing with 100% inspection.

The LF-S11 SY is suitable for laboratory applications, statistical purposes, and off-line leak testing. It performs the leak testing process after the Pre-filled Syringe is manually loaded into the test chamber by an operator. Following the testing process, the containers are manually unloaded from the chamber and they are managed according to the results of the test. This equipment is fully compliant with the requirements of 21 CFR part 11.

To find out more about the Benchtop CFR21 Part 11 Compliant CCI Tester LF-S11 SY please contact our representatives.

WUXI BIOLOGICS chooses Fedegari for its largest bio-manufacturing facility in Ireland

WuXi Biologics, Chinese world leader in the production of biotech pharmaceuticals, has chosen Fedegari Group to supply 15 high-performance process machines – GMP washers and autoclaves – for its new production site in Ireland.

The new headquarters to be inaugurated in Dundalk will receive investments of 325 MEUR and the construction will provide the employment of 700 people with the creation of 600 new jobs by 2024. The manufacturing project in a 26-hectare campus, the company’s first site outside of China, is supported by the Irish Government through IDA Ireland.

Wuxi’s state-of-the-art facility will employ multiple single-use bioreactors for commercial biomanufacturing and is designed to be able to run continuous bioprocessing, a next generation manufacturing technology to be first implemented globally in this campus. A total of 48,000 l fed-batch and 6,000 l perfusion bioreactor capacity will be installed, representing the world’s largest facility using single-use bioreactors.

“The global bio/pharma market is changing, and we are experiencing an ever-growing interest in our business model. The pre-requisite for introducing more cost-effective and reliable drug manufacturing solutions is a strong technical partnership between end-users and, equipment suppliers. Without a rock-solid relationship of trust, the end-users will not dare to invest in unconventional solutions. However, this relationship will not develop out of bombastic statements on a website rather is the consequence of a tested technical relationship”, said Giuseppe Fedegari, President of the group.

The collaboration between Fedegari and WuXi began in China in 2018. The new project in Ireland strengthens the relationship with the supply of 8 high- performance sterilizers and 7 eco-steam washers for a value of about 4 MEUR.

This agreement consolidates Fedegari presence in the Asian market, which corresponds to 30% of the company revenues.

If you want to learn more about the Fedegari product line contact our office today and discuss your upcoming project with our representatives.

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