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.

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.

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.

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.

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.

Vetromeccanica AirTech

Vetromeccanica recently introduced their brand new AirTech system.

The AirTech is an Air Conveyors Solution extremely efficient for Empty Containers.

AirTech enables production chains to move empty containers evenly in case of high inclination (slope of max. 15° according to the bottle shape). This conveying solution allows Maximum flexibility, manageability and fast format change where a switch of containers is done in a single line. One of the best features of the new AirTech system are the redesigned body guides that provide customers with an automatic adjustment system included in their conveyor.

AirTech belongs to the Air conveying solution, which are conveyors that use air to move products and materials rather than mechanical belts or chains. Air conveyors are most widely used to move lightweight objects such as empty containers, boxes, and trays at speeds often exceeding 1,000 fpm. However, AirTech can be configured not to be limited to lightweight materials.

To learn more about Vetromeccanica’s AirTech, feel free to connect with our representatives.

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.

Steritalks – Understanding Moist-heat Sterilization Principle

we are glad to share with you that FEDEGARI have decided to organize new sessions of Steritalks dedicated to the North American market.

For those who didn’t have the chance to learn about the project yet, it is a 30-minutes live discussion that gives participants the opportunity to have fast and free advice from Fedegari R&D experts.

Due to the success of the first sessions worldwide, we will repeat the formula starting from a topic that generated significant interest also at our latest PDA training in Italy:

Understanding Moist-heat Sterilization Principles on Thursday, June 4th – 11:00 AM EST.

Steritalks is a live discussion with our experts on sterilization and related topics. It brings to the participants an easy understanding and sharing of common questions and answers on sterile processes such as sterilization, decontamination, washing, and contamination control.

Each session starts with our experts sharing practical knowledge on a specific topic.

You can request your participation at our live sessions to join the conversation.

In case of acceptance, you will receive an invitation with indications to connect via Webex.

To Register please visit: https://fedegari.com/en/steritalks/

Serrated caps torque testing

Serrated caps frequently used in the beverage and pharmaceutical industry are prone to slippage during torque tests especially when used with hand testers or “universal” type chuck solutions. Torqo, the computerized cap torque testing unit offered from Mesa Labs, offers a customized chuck for each bottle and cap type developed from samples provided by the customer. These customized chucks provide significant advantages including:

1. Ensuring the most accurate testing because the EDM chuck is designed to exactly fit the unique serration pattern of the closure.

2. Allowing for consistent and repeatable testing because the chuck fits the cap the same way each time. It cannot be adjusted.

3. Reduces the prep time before the test because the user does not have to re-adjust the universal plugs.

Using a customized chuck for cap torque testing not only will provide more consistent results but also will save set up time for the user and thus increase productivity.

To receive a quote based on your exact bottle and cap, contact LSI today.

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