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What if vaccines get too warm?

In healthcare, helping secure patient safety is crucial. That’s why health care providers work tirelessly to ensure their actions support this mission. Though despite their best efforts, mistakes happen, and unfortunately, vaccine storage solutions aren’t often up to standards. For instance, in October 2017, a healthcare agency in California made an accidental, but unfortunate overcorrection. Due to concerns that their vaccines were too warm while in transport, they utilized ice packs to cool them down. Later, a routine audit found that some vaccines became too cold and froze during the drive.

Because they couldn’t say for sure which vaccines maintained the integrity and which ones didn’t, everyone who received their vaccines required reimmunizations.

In the end, this mistake affected 23,000 patients.

As mistrust in vaccine integrity grows, there is no room for error. Nevertheless, there are steps healthcare providers can take to avoid the worst and stay prepared.

We’ve recently published an article covering the importance of having a dependable vaccine storage installed on site, but today we shift our attention to controlling and monitoring equipment for the complete cold supply chain.

Not Too Hot, Not Too Cold: Maintaining the Perfect Temperature Range

Preparing for the what-ifs is an essential part of working in healthcare environments. First things first, always read the packet insert provided by your distributor. This insert will guide you to the right storage temperature for your vaccine.

For more guidance, here’s what The Centers for Disease Control and Prevention (CDC) suggests for ideal temperature ranges:

  • Refrigerators should maintain temperatures between 2° C and 8° C (36° F and 46° F).
  • Freezers should maintain temperatures between -50° C and -15° C (-58° F and +5° F). Refrigerator or freezer thermostats should be set at the factory-set or midpoint temperature, which will decrease the likelihood of temperature excursions.

Another element that affects the temperature of your vaccine is the placement. For instance, avoid storing vaccines in refrigerator doors as opening and closing the doors makes vaccines vulnerable to warmer temperatures. In fact, the CDC recommends storing your vaccines in the middle of the fridge and placing older assets towards the front, so utilization happens before they expire.

All in all, proper monitoring is crucial to ensure that your assets maintain integrity.

The truth is, it takes a village and then some. Following guidelines that support successful audits and healthy patients is critical. That’s why manually monitoring the temperature of your storage units is not always the best solution. Having a continuous temperature monitoring system in place that not only alerts you when your temperature goes awry but also keeps accurate records of every temperature your units are experiencing is essential.

When you have an action plan, you worry less. If you want better certainty that the vaccines you’re giving patients are potent, you need a temperature monitoring system in place that sends you alerts and notifications when something goes wrong.

Many monitoring systems come equipped with an alert function. Some facilities prefer to use continuous monitoring systems that utilize the phone tree method. This method sends notifications to one member of the team when their designated parameters drop below requirements making them the first line of defense. If the first member of the team is unable to go on-site to address the problem, they can choose to pass the alert to the next person on the list.

Having a system in place that has thorough reporting for audits is non-negotiable. These reviews verify that you’re doing everything in your power to provide excellent patient care, and your reporting system will prove this. In turn, an adequate reporting system saves your team time and ensures that your paperwork will be in order when governing bodies like the FDA or Joint Commission come knocking.

Having proper notifications allows you to address the problem immediately, wasting no time.

For example, with Mesa’s ViewPoint Temperature Monitoring System alerts users of any readings that are outside the programmed acceptable range for that appliance undergoing monitoring. The ViewPoint monitoring system emails and sends text notifications of an alarm state to users’ day or night. Multiple email addresses, cell phone numbers, and alarm notification lists can be utilized, providing the client with the best line of defense against any issue regarding your valuable products.

With ViewPoint, healthcare workers maintain full transparency with their assets and that security is priceless.

Priority: Potent Vaccines

Achieving Effective Assets with Continuous Monitoring

When it comes to safeguarding your valuable assets, your monitoring tools should be the best. Healthcare environments are complex, and when data is funneling in from multiple inputs, or hand recording is utilized, the complication amplifies. That’s why it’s crucial to create a system that gives you reliable and usable data along with accurate reports that meet regulatory requirements.

Ensuring drugs remain valid, and blood samples maintain viability is critical to mitigating product loss and health risks. To do so, you will need an efficient, flexible continuous monitoring system that upholds all regulatory requirements.

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.

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.

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.

Versa Fill by Cozzoli

The Versa-Fil employs either a selector star or optional timing screw to evenly space containers into an infeed starwheel. They are transferred onto a rotating plate and centered directly under the filling nozzles. Containers are then filled and transferred by a discharge starwheel back onto the automatic conveyor.

High-precision positive displacement pumps feed product into the filling slots of the metering plate and through the nozzles into a container as it passes under the filling slot.

• Pump and machine drives are electronically phase loop synchronized to insure filling accuracies to +/- .5% with most products.

• Fill quantities are rapidly adjusted by varying the speed of the product supply pumps in relation to the machine speed.

• Optional lift platforms provide a bottom-up fill to eliminate air entrapment and minimize product disturbance

FILLING PRINCIPLE

The product is pumped from positive displacement pumps into slots of the stationary metering plate. The lower disc and nozzles rotate as an assembly under the non-rotating upper disc and metering plate. Holes in the lower disc pass under the slots in the metering plate and transfer product to the filling nozzles. Quantity of the product depends on the pump speed in relation to the machine speed which determines the time that the nozzles are under the slot.

STANDARD FEATURES

• Time/pressure fill principle utilizing sanitary positive displacement pumps

• Pump and machine drive electronically phase loop synchronized

• Accuracies of +/- .5% attainable on most applications

• Wetted contact parts of type 316 stainless steel and FDA approved virgin Teflon

• Suitable for high temperature filling

• Type 316 stainless steel straight down nozzles

• Built-in safety devices to shut off machine in the event of a jam

• Fills both rigid and flexible containers

• Selector infeed mechanism to space containers into infeed stars

• Rapid container changeover

• Nozzles, upper head, and pumps quickly disassembled for ease of cleaning and sterilization.

• All drives enclosed; no exposed belts or pulleys

• Centralized lubrication

• Left to right operation

• Stainless steel conveyor frame synchronized with machine driven 4.5” Delrin chain

• Stainless steel cabinet guarding

• Stainless steel lower rotating plate complete with flowthrough holes for top filling and ease of cleanup

• LED readout in containers per minute

• Electronic programmable logic controller

• Container jam protection with clutch on spiral

Contact LSI today to learn more about the latest personal care filling technologies.

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.

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