STERILITY TEST ISOLATOR with Built-in Hydrogen Peroxide Vaporizer

The FCTS Sterility Test Isolator has been designed for pharmaceutical samples taken from manufactured drug batches and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Suitable for:

  • Injectable liquids.
  • Ophthalmic ointments.
  • Sterile antibiotic powders.
  • Freeze-dried drugs.

When Fedegari started designing its first isolator, the goal was assuring customers the highest process reliability and repeatability possible.

FCTS sterility test isolator is equipped with the same solution that Fedegari has standardized in bio-decontamination pass-boxes, because the performances and the reliability of third party H2O2 vaporizers were not satisfactory. Moreover, with the FHPV there is no need of propietary consumables, reducing significantly operational costs.

This innovative design provides real time biocide concentration control (over traditional estimated calculations).

Through the H2O2 sensors and other devices, Thema4 assures that vapor concentration remains extremely constant (within ± 15 ppm) thus making process repeatability the logical consequence.

The FCTS sterility test isolator is compliant with the most stringent cGMP guidelines of Pharmacopeia. It has been classified as ISO 5 FDA and Class A EU GMP.

DESIGN & TECHNICAL FEATURES

  • Working chamber has non-directional BA surface finishing (Ra ≤ 0.4 μm).
  • Air-tightness is 100% guaranteed by ultra-safe doors.
  • Equipped with an internal stainless steel trolley for material transfer from pass-box to working chamber assuring continuous loading of the isolator with materials.
  • Customizable internal storage and racks: can be designed according to customers’ needs.
  • FCTS is modular: customers can choose the positioning of the pass-box, the number of working chambers and gloves.

KEY BENEFITS

  • Significantly reduced operational costs: Non-proprietary consumables.
  • Reliability: Leak testing totally managed by Thema4.
  • Easy integration, throught Thema4, with other Fedegari machines and SCADA systems.
  • Cost-effectiveness: Drastically reduced validation time for cycle and load.
  • 100% air tightness: Silicon inflatable patented gasket on all doors.
  • Process control based on direct feedback, instead of estimations.
  • Grids and internal spaces that can be customized according to the load.
  • RTP Port for loading and unloading activities.

COMPLIANT TO

  • European directives: 2014/30/EU – electromagnetic compatibility (EMC), 2014/35/EU – Low tension equipment (LVD), 2006/95/EC – Safety of machinery (MD)
  • European standards: EN 55011, EN IEC 61000-4-2, EN IEC 61000-4-4, EN IEC 60204-1
  • FDA: compliance for non metallic component in contact with process fluids
  • GMP
  • GAMP5
  • 21 CFR Part 210, 211 e 11
  • UL 508A
  • NFPA-79
  • ASME BPE

Optional

  • US electrical norms: NFPA 70 – National electrical code,  UL 61010-1 – Safety requirement for electrical equipment for measurement, control and laboratory use – Part 1: general requirements.

Want to know more about our certifications? Please visit the dedicated section or do not hesitate to contact us.

COVID-19 Vaccine Storage

The COVID-19 pandemic is changing rapidly and requires different strategies to maintain clinical preventive services, including immunization. The race to develop, produce, and distribute the first effective vaccine for the SARS-COV-2 virus has alerted a lot of governments to pre-order huge doses of the vaccine as soon it becomes available and goes into production.

As Covid-19 vaccine trials enter a defining stage worldwide, authorities Worldwide have started preliminary discussions on a wide range of issues, from logistics to ethical questions, to set the stage for a smooth supply and effective use of a vaccine when it is ready.

We do have some concerns regarding the integrity of the stored vaccines as most of the vaccine administration facilities don’t meet the storage requirements for such a high volume of vials and syringes being stored at a single point of time. Proper vaccine storage and handling practices play a very important role in protecting individuals and communities from vaccine-preventable diseases. Vaccine quality is the shared responsibility of everyone involved, from the time vaccine is manufactured until it is administered.

Our concerns are that developing a successful COVID-19 vaccine is only half the battle. We all know that most vaccines must be kept refrigerated at frozen or near-freezing temperatures to remain stable. That’s a problem when you consider that there isn’t enough refrigerated space in the world to store 7.8 billion vaccine doses. In addition, it’s highly anticipated that many of the vaccines that are being tested right now—or that are in early development stages—are going to need multiple doses, which further complicates the logistics of rapidly delivering vaccines to billions of people. Imagine of having to take 3 revaccinations for the vaccine to be effective.

This means that there is a serious storage concern because at a single point of time we might need to have approximately 24 billion lots of vaccines stored in a freezer or a stability chamber.

Once there is a vaccine for the virus that causes COVID-19, administering it will need to be just as successful as the vaccine itself. If the vaccine needs to be administered in multiple shots —like the HPV vaccine, which requires three—this may significantly reduce how much of the global population is successfully vaccinated.

Addressing the Storage Concerns

The WHO Vaccine Storage Guidelines provide information and advice for vaccine storage management for immunization service providers, from medical practices to large hospitals, clinics, and outreach providers.

WHO refers to 5 degrees Celsius (°C) — that is, the point midway between +2°C and +8°C which is the temperature range recommended for vaccine storage. Many vaccines are damaged or destroyed at temperatures outside this range.

With the help of Bahnson’s Steve Ferguson, we did a comprehensive webinar broadcast where we discussed the proper vaccine storage methodologies. Due to the current trends, we are now offering a rerun of the same talk which was recorded in 2017.

Bahnson Environmental Specialties (BES) designs and manufactures a diverse product line of controlled environmental chambers/rooms throughout a wide variety of industries.

In the pharmaceutical market, BES’ focuses on stability rooms meeting and exceeding the ranges and uniformities of the ICH has allowed us to become the recognized leader in chamber design, construction, and stringent performance qualification in support of our clients’ validation.

For the growing demand for ultra low-temperature storage for vaccines, BES manufactures the Low Temp (LT) chamber series.  This product series includes the Low Temp Chest (LTC), Low Temp Upright (LTU), and the popular Low Temp Walk-in (LTW).

The products provide from approximately 80 cubic feet to over 1000 cubic feet of ultra-low -70 to -80 C freezer storage area and are typically used to support biorepository needs for ultracold temp storage freezer vaults or cold storage vaults.

All products are custom designed to a specific size, temperature, and electrical control specifications.  Typical storage includes small vials, plates, bulk drums, and canisters of various biological samples and vaccine products.

Maximum capacity, multi-temperature, and storage flexibility and product protection are essential to design elements available in the most unique cascade freezers on the market today.

This is actually a new solution to the antiquated ‘freezer farm’ approach which uses individual freezers with single, common refrigeration systems to store large volumes of products. This is finally, a solution better than “just adding one more freezer”.

Our final advice will be to also check out the webinar we did with Dan Gresens of Bahnson where he explained the concepts for Site Considerations and Preparations for Environmental Chambers.

If you want to have a further conversation on how we can help out with your vaccine storage needs, please get in touch with us via 800-829-5741.

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.

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.

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.

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.

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.

LF of America Your Partner In Contract Filling Florida

If you are in need of contract filling services in Florida, you’ll want to know you can depend on the company you choose. When it comes to the contract packaging and filling industry, little more is as important as reliability. 
Any business that can’t rely on their contract filling services, its reputation is what gets hurt the worst. Proper protocols, handling, and a commitment to following any regulatory practices are all just as important. 

An error to follow these vital standards could amount to your product becoming tainted or less effective than it is meant to be. Similarly, a disruption in ongoing fulfillment can slow your own production and leave your business with significant problems to overcome.

These factors stand true for almost all imaginable industries. Whether OTC products, diagnostics, health and beauty, or something else entirely, contract filling plays a highly important ongoing role.
Fortunately, for anyone looking for an experienced and reliable Florida contract filling and packaging company, our experts can help. 

Contact LF of America today to speak with a member of our team and learn more about what makes us the premier choice in contract filling services below.

Your Source For Reliable Contract Filling Services In Florida

LF of America is the leading provider of contract filling services and liquid packaging solutions in the US. Our experienced team understands that every time a client entrusts us with their products, we become a vital part of the company’s chain.

For this reason, we put a strong emphasis on safety and compliance during each phase of the production process. It’s important to us that each and every one of our clients knows they can depend on our contract filling services to be done in a safe, effective manner.

To achieve this, we handle all of our services in contained settings with our state of the art facility. Our semi-automatic and automatic filling and sealing machines are some of the most highly advanced available, equally capable of handling small batch orders to large full-scale production sizes.
The filling and sealing machines are stationed inside our ISO-8 clean room. The ISO-8 cleanroom is immaculately maintained to remain in total compliance with Cosmetic GMP regulations, an extension of the Quality System Requirements for medical devices.

Contract Packaging Options

For packaging options, our contract filling services can be performed using your own existing containers or you can choose from our diverse variety of packaging types. Our collection of innovative packaging options include unit-dose packaging, Bellow Bottles, wand tubes, enema containers, bottles with droppers, dual chamber bottles, and more.
All of the different types of options available through our packaging manufacturing department are suitable for many different applications. Please fill out an inquiry form to request our help with developing a unique packaging solution that is ideal for your intended purposes.

If you would like to receive a free estimate regarding the cost of our Florida contract filling services, call LF of America at 561-988-0303.

Moving forward, consider the entire LF team your ideal packaging partner to help your business continue to grow and achieve the goals you set out to conquer.

Cozzoli Ampoule Filling Machines

Our full line of Cozzoli ampoule filling and sealing machines accommodate a range of products from aqueous solutions to powders and even pellet applications. These high-speed ampoule filling and sealing machines are versatile, compact, and self-contained. These features, along with the accessibility of parts and minimal changeover time contribute to the successful operation of these machines.

The FPS – Ampoule Filling and Sealing machine is ideal for filling and sealing ampoules with speeds from 15-120 ampoules per minute and a fill accuracy of +/- .5%. The FPS is designed with a sealed top cover plate to ensure the internal drive mechanism remains free of extraneous matter.

The FPS series is a compact ampoule filling and sealing monoblock machine; featuring an unscrambler, flushing and filling stations and is known for it’s simplicity, operational reliability and minimal maintenance factors. Utilizing Cozzoli’s exclusively patented sliding tube valve, the FPS uses stainless steel syringes and positive head pressure to fill the product with outer diameter dimensions up to 1” (25.4mm) at full speed. Ampoules from 25.4mm to 28.6mm can be handled by alternate indexing.

Fill volume can be changed by a simple adjustment of a calibrated sector arm. Volumetric accuracy of fill is +/- 0.5%. Bottom-up filling is provided through the provision of two cams to lower and raise on a 2” or 5” stroke. Other cams are available for any special bottom up filling requirements.

Since the blending of proper amounts of oxygen and gas is important for effective sealing of the ampule, this machine can be optionally equipped with a dual flow meter assembly that will visually indicate the oxygen and gas flow separately.

Interested in discussing your ampoule filling needs, contact us today.

Integrity testing for IV bags

IV bags come in various sizes and configurations. And we understand the importance of ensuring the integrity of the vital drugs and nutrients they contain. No matter the size or contents, with testing methods that include Vacuum Decay and Force Decay, you can feel confident your IV bags will always be ready when they are needed the most.

Vacuum Decay tester for IV bags:

In-line Pharmaceutical on-pucks Tester

Non-Invasive, Non-Destructive, 100% in-line Integrity Inspection System Testing at high production speed for all pharmaceutical containers tested into dedicated Pucks

Container Closure Integrity Testing is a non-destructive measurement technology based on Vacuum Decay Method.
The measurement system comprises applying a pressure differential into an airtight testing group enclosing the container.
The test objective is to detect container leakages by measuring the reached vacuum level as well as the vacuum change over test time.

Force Decay tester for IV bags:

LDB – Leak Tester

100% Off-line Machine for Non-Invasive, Non-Destructive Integrity Inspection for hermetically form filled package systems.

 Highlights

  • Zero alteration of container features
  • High machine adaptability & stability
  • Adjustable force level check
  • Easy management
  • Low energy consumption
  • Low & Ease of maintenance: free access to all moving parts
  • Full integration in Industry 4.0 Environment

Container Closure Integrity Testing is a non-destructive measurement technology based on the Force Decay method, which analyses the force level variation following container mechanical pressing works on a broad range of hermetically form filled package systems

This method is accomplished by:

  • Container mechanical pressing.
  • Container reaction according to its status.
  • Reactive force level acquisition with a force sensor.
  • Decision making (approval or rejection).
0 visitors online now
0 guests, 0 members
Max visitors today: 3 at 12:00 am
This month: 32 at 08-09-2020 02:04 am
This year: 112 at 05-24-2020 05:06 pm
All time: 253 at 10-02-2019 01:57 am