Category Archives: Vaccines Cold Chain

Making an Informed Decision on Your Passive Protection

Protek Pharma Worldwide, who have recently opened a 2,300m2 production facility in Verona, Italy, are making great strides with their expansion within the European market.

The cold chain logistics passive protection specialists are continuing their growth and availability of their innovative SureTemp® products.

Using their 50 years of combined expertise in manufacturing thermal insulated shipping components and solutions, Protek have created this informative video.

This stats-led animation gleans insight into the industry as a whole and gives useful advice on ensuring you’re making the correct decisions when shipping your products, from paperwork to protection.

About Protek Cargo

Protek manufactures industry leading SureTemp® passive temperature protection solutions for product distribution via Air, Ocean, Ground and Intermodal transport modes. Protek services the Beverage, Perishables, Pharmaceutical and Industrial markets. We provide stock and custom engineered designs using advanced materials, including proprietary enhanced Pallet Covers.

Uniform global sourcing from plants in the Americas, Europe and Asia ensure quality control and stable supply. Experienced Reuse/Recycle management programs create additional operational savings and lower packaging’s environmental impact.

VaccinePorter Carrier Systems

VaccinePorter® Carrier Systems –

keeping medicines effective for the last mile

Temperature controlled biomedicines such as Vaccines are actively or passively regulated at a thermal level different from the surrounding ambient environment. Vaccines are transported in refrigerated containers to surgeries and local vaccine storage facilities where they are then stored in special vaccine fridges, ready to be delivered to administration sites including schools, clinics and care homes.

Keeping cold chain medicines within the +2°C and +8°C temperature range is a difficult and risky process, having products too cold causes deterioration or too warm can render them inert. Medicines stored and transported correctly reduce any risk of compromising their quality, efficacy and safety, so using a proven validated cool box is essential.

Helapet VaccinePorter® Carriers allow for safe, controlled transit of temperature sensitive products between +2°C and +8°C for up to 8 hours, even with multiple openings for multi-site deliveries. Validation documentation assures the users that the controlled product is safe in transit, maintaining integrity right up to the point of patient administration.

VaccinePorter® Carriers are available in various capacity sizes granting flexibility for a multitude of healthcare applications, from inter-department transportation in hospitals to community immunisation programmes. Various biomedicines included in cold chain transportation include:

Vaccinations
Insulin
Anti-cancer drugs
Monoclonal antibodies

Simple and quick to prepare, each VaccinePorter® Carrier comes with a lightweight fully replaceable components to cost effectively maintain thermal performance. Each carrier incorporates a secure Velcro® fastening and tamper evident facility to prevent theft and a clear document holder allowing for easy storage of accompanying information.

Supplied in 5 different sizes VaccinePorter® Carriers can accommodate up to 8 litres of product. Pick out your preferred size by requesting your hard copy of our VaccinePorter brochure, simply by emailing info@helapet.co.uk.

Why not talk to us today and see how VaccinePorter^® Carriers can satisfy your transport requirements by calling 01582 501980. Visit us at www.helapet.co.uk to learn more

France’s national blood transfusion service, the Établissement Français de Sang (EFS) – interview with Dr Jean-Pierre Zappitelli

Dr Jean-Pierre Zappitelli is a pharmacologist and biologist, who works as the senior manager of the Aix-en-Provence laboratory of France’s national blood transfusion service, the Établissement Français de Sang (EFS). He discusses his work within the context of managing the cold chain for blood products

How does the EFS laboratory in Aix-en-Provence fit in with the rest of the EFS and how would you describe your work?

The EFS is France’s sole operator of blood transfusions and its work covers the processing of donations of blood, plasma and platelets. The EFS is France’s safety guarantor of the blood transfusion chain, from donor to recipient. It supports the care of over 1 million patients per annum across France and its overseas territories via 132 fixed and some 40,000 mobile donation sites.

pic-1-esf-laboratories-in-alpes-mediterrarnee-region The EFS laboratory in Aix-en-Provence is a reception and distribution point of blood products that have been tested post-donation for pathogens and are ready to be used. In 2015, it processed 20,148 units of blood products (17,529 units of red blood cells; 1,148 units of platelets and 1,471 units of plasma) for the care of 3,759 patients.

I’m the Aix-en-Provence laboratory’s senior manager responsible for delivery and distribution of blood products. By “delivery”, we mean blood products for specific named patients, while by “distribution” we mean for unnamed patients, for instance for hospital stock top-ups.

My work involves ensuring firstly that all of the products we receive are safe to use; secondly that while these products are in the laboratory’s care, they are stored correctly; and lastly, that they are correctly labelled and packed when they leave the laboratory.

How does the Aix-en-Provence laboratory manage the cold chain for the blood products in its care?

This is achieved by maintaining and monitoring the temperature in various areas in the laboratory.

Firstly, the ambient temperature in the laboratory itself is maintained at 25°C. We do this because this is the recommended temperature for the products that are used to determine blood type. If for some reason, this temperature level of 25°C is breached, an alarm sounds and dealing with this issue becomes the primary task that is attended to.

pic-2-refrigerator-temperature-monitor Secondly, all units of blood products – platelets, red blood cells and plasma – are all kept in their own designated refrigerators. These all have a temperature indicator on their door, as well as an independent temperature monitor that is linked to an online map of all of the refrigerators in the laboratory, that is updated in real time with a full suite of data analytics.

The laboratory’s refrigerators have a safety feature whereby whenever one is opened and then closed, a magnet is activated and it cannot be opened for one minute in order to restore the correct ambient temperature within it.

Thirdly, all units of blood products come to the laboratory from regional stock in their own type of container with a “thermo-button” temperature data logger that has monitored the ambient temperature within every container we receive. These temperature data logger are checked using a sensor linked to a PC to ensure that the cold chain wasn’t broken prior to reception. (Some other laboratories in the region use RFID data loggers and for these, the crates don’t need to be opened for data monitoring downloads.)

Also, all the bags of products in a group of bags are attached together with a self-locking cable tie that can only be removed by cutting it with pliers.

For blood products that leave our laboratory or may be returned, we group these units of blood products with both a self-locking cable tie and a thermo-button temperature data logger.

Lastly, every group of blood product bags is labelled with a tag indicating source, destination, required temperature and a security notice around handling. Also, every bag of blood product has its own barcode allowing for full traceability.

The laboratory also needs to consider how deliveries of bags of blood products are managed and for this we use two systems: either refrigerated vehicles or isothermal padding.

For bags of red blood cells and platelets, plastic crates are used for transportation in refrigerated vehicles. The crates contain the appropriate type of ice-pack to ensure optimal temperature levels within the crates. Also, these let in the cooled refrigerated air within the vehicle to further ensure that the correct temperature is maintained within them.

For deliveries of bags of frozen plasma, air-tight isothermal crates with extra isothermal padding and its appropriate type of ice-pack. Also, all units of frozen plasma are protected with bubble wrap to avoid any breakages during transportation.

Lastly, all crates are labelled with information regarding source, destination, required temperature and a security notice around handling. Naturally, only authorised personnel can open a crate and this too is indicated on every crate.

How does the laboratory manage suspect items?

The main rule we work by is to eliminate all doubt around decision making about a product. Either it is objectively safe to use or it isn’t, and both of these scenarios are backed up by data, or a lack thereof.

Until we can determine that a suspect unit of product is safe to use, it’s placed in a quarantine refrigerator until its safety has been 100% confirmed. If this can be done, it then is moved to the appropriate refrigerator. If this cannot be done, it’s disposed of by means of incineration.

Also, any such suspect product, which goes on to be disposed of, is fully documented to ensure full traceability.

In the lab, we make sure that the technicians who process the products we process are never in any doubt about what course of action they need to take.

Our safety systems are built to enable any of our processes to stop at any point. There’s simply no room for error. Patients’ lives are at stake.

What are the risks if the cold chain is broken (plus or minus)?

The risks associated with managing the cold chain for blood products underpins all our work.

If the cold chain for a bag of red blood cells is broken, say during transport, and its core temperature rises above 10°C, the risk is that the patient receives a transfusion that is infected by potentially harmful bacteria. And even with minute amounts of bacteria, at temperatures above 10°C bacterial reproduction can be considerable. For a healthy person, this needn’t necessarily be a problem, but for an already weakened sick patient, it can be extremely dangerous. And for temperatures below 2°C, the risk here is that ice crystals will form, thus impairing its oxygenation property.

Similarly, if platelets are stored or transported at temperatures below the specified limit, there is also an inefficiency risk. So if for example these are stored or transported at a temperature of 12°C instead of 24°C, the purpose of the transfusion (to replace platelets further to some chemotherapy therapy) will be adversely affected, which again poses a danger to the patient. And just like red blood cells stored or transported at a temperature above 24°C, the risk is bacterial reproduction is very high.

pic-5-bag-of-frozen-plasma-1 For plasma, the risk when the cold chain is breached is that the product will be altered very rapidly. Plasma is an extremely fragile product that must be used within six hours of being unfrozen.

The final risk around managing the cold chain for blood products is around the labelling of each item. This is why we use various identification tools, including unique barcodes on every bag of blood product. During transport for instance, correct labelling ensures the timely and correct delivery of blood products.

When this doesn’t happen, stocks of blood products could be either delivered to the wrong destination, or arrive late, leading to patients not benefiting from them when they need them or a hospital’s stocks running low, or worse running out, which again puts patients at risk. Furthermore, incorrect labelling inevitably leads to unnecessary wastage to eliminate any chance of putting a patient at risk with a potentially unsound product.

Managing these risks is why for every unit of blood product, there has to be absolute certainty regarding where it’s come from and what its destination is. There’s no room for any grey areas in our work. We only work with 100% certainty around the safety protocols for the blood products we process.

Cold Chain Coolers – The Cool Ice Box Company

This year The Cool Ice Box Company decided to focus heavily on non-powered Cold Chain Coolers for the medical, pharmaceutical and veterinary industries with greater emphasis on technical data and cold chain transportation information.

With this in mind, we have created a new medical device website – www.medicalcoldchainboxes.com

The Cool Ice Box Company Ltd has long been the professional choice for scientific and medical cold chain logistics. Founded in 2008, the company is highly regarded for its expertise in providing products developed with highly advanced technology. This enables the holding of frozen or refrigerated contents for longer periods of time at low or sub zero temperatures without the use of external energy sources. Thus ensuring safe transportation of diagnostic samples from the extraction centre to the laboratory keeping the contents in order and perfect conditions.

The Cool Ice Box Company product range includes medical and consumable cold chain products, lifestyle cooler products and cold packs. We continues to source and design new and more innovative products. The latest additions to support the impressive product range are Nomad Travel cases, the AL Range; and tracking thermometers and data loggers.

Our Medical Cold Chain coolers are used for medical, vaccines, pharmaceuticals, blood, organ donation, stem cells, in fact anything that needs to be kept within the WHO guideline temperature of between 2- 8 C degrees.

To further develop our business we intend to focus on supplying specialist laboratory temperature control equipment for the medical, food, pharmaceutical and other life science related applications.

For more information, please go to our websites :

www.coolicebox.com
www.medicalcoldchainboxes.com

Telephone : 0044 (0)1598 740685

Helapet Cold Chain VaccinePorter Carrying systems

Helapet VaccinePorter carrying systems are designed for the safe and controlled transportation of vaccines and temperature sensitive solutions. Featuring a replaceable inner moulding surrounded by a strong carrying bag, the VaccinePorter range can effectively maintain a temperature threshold of between +2°C and +8°C for extended periods of time whatever the external conditions.

Ideal for the transit of an increasing number of products requiring controlled storage conditions, the VaccinePorter is available in a selection of sizes and volume options. A custom design service is also available for specific colour and artwork requirements*

MediCool technology

VaccinePorter carrying systems use MediCool packs which can be repeatedly used to maintain the internal storage temperature. Comprised of a water based non-toxic solution, MediCool packs can be configured in each porter, eliminating the need for ice and improving storage capacity.

Safety and Security

With strong carrying straps for safe lifting and handling and a secure velcro fastening system, the Helapet Vaccine Porterenables quick access whilst providing extra protection for the inner chamber. When security is an issue, a tamper evident closure system is available.

Replacement inners to save money

Each VaccinePorter utilises a fully replaceable polystyrene inner moulding to store and protect the transported product. Tailored to the size of each Vaccineporter, customers can order replacement inner mouldings from Helapet to maintain the chamber integrity

For further information or a free demonstration on our range of cold chain transportation systems, contact us on our dedicated freephone number 0800 230 0191 or email porters@helapet.co.uk order replacement inner mouldings from Helapet to maintain the chamber integrity.

Keep updated on Helapet Cold Chain Management developments on www.helapet.co.uk, or visiting our Facebook and Twitter pages

July is GBS ( Group B Streptococcus) Awareness Month – A Simple Test to Save a Life

Do you know about group B Strep?

Expecting a baby can be one of the best times of your life. It’s a time when it’s important to know about group B Streptococcus (group B Strep/GBS) as it is the most common cause of severe infection in newborn babies.

July offer – ECM testing pack for £29

What is GBS?

GBS is a common bacterium which is present in the intestines of up to one in every three adults and in the vagina of approximately one in every four women. Carrying it has no symptoms and whilst GBS does not cause infections in healthy people, it can affect new born babies. Carrying GBS around the time of giving birth is recognised as an important risk factor for severe infection in newborn babies, yet women in the UK are rarely told about it by their health professionals and even more rarely offered testing.

July is GBS Awareness Month – A Simple Test to Save a Life

Many babies are exposed to GBS without any ill effects but some are susceptible to the bacteria and develop infection. When GBS gets into the bloodstream or lungs of a newborn baby, it can cause infections such as sepsis and pneumonia. Most GBS infections in babies develop within the first few hours of life (called early onset GBS infection) and, less commonly, it can develop up to the age of three months (late onset GBS infection). Late onset GBS infections are more likely to include meningitis, with many of the survivors suffering life-long disabilities.

Most GBS infection in newborn babies can be prevented by identifying which babies are at higher risk and giving the mums-to-be intravenous antibiotics during labour.

How do women know if they have GBS?

GBS colonises the intestines of around a third of humans with no symptoms at all; it is a normal body commensal (usually harmless bacteria or other organisms that normally live in or on the body. GBS normally cause no harm or symptoms to the carrier and therefore colonisation may be intermittent. In women, the bacteria often colonises the vagina.

The method used for GBS detection is critical for obtaining accurate results for GBS carriage. When done properly, antenatal GBS screening can give a very good indication as to the carriage status of the mother at delivery.

Testing for GBS is not routinely offered in the UK and many NHS hospitals don’t have access to the sensitive ‘gold standard’ ECM (Enriched Culture Medium) tests for GBS carriage. ECM tests are available from a number of NHS Trusts, plus privately at clinics and through home-testing packs which cost around £35 each. For availability, see www.gbss.org.uk/test.

To predict with greater accuracy the chances of carrying GBS at delivery, the best time to test is at between 35 and 37 weeks of pregnancy using a vaginal and rectal swab. Testing later than 37 weeks increases the chance that the baby will be born before the result is available.

Many more GBS infections in newborn babies could be prevented by offering all pregnant women the sensitive ‘gold standard’ ECM test and offering intravenous antibiotics to those carrying GBS to prevent the infection occurring in the newborn baby.

What else should I know?

A baby is more likely to develop GBS infection when:

Mum has previously had a baby who had GBS infection
GBS is found in Mum’s urine or on a swab this pregnancy
Mum has a high temperature in labour
Labour starts or waters break before 37 completed weeks of pregnancy
Waters break more than 18 hours before the baby is born

If GBS is found in the urine during pregnancy, Mum will be given oral antibiotics to clear the infection. She will also be offered intravenous antibiotics in labour against GBS infection developing in her baby. The use of antibiotics at this stage reduces the risk of GBS infection in the newborns from around a one in 300 risk to less than one in 6,000.

If GBS has only been found from a vaginal or rectal swab, antibiotics aren’t given as they’re not beneficial during pregnancy until labour starts, when they should be offered.

What does charity Group B Strep Support want to see?

Group B Strep Support (www.gbss.org.uk), founded in 1996, is the UK’s only charity focussed on GBS infection in newborn babies – promoting greater awareness and improving prevention of these usually avoidable but potentially life-threatening infections. The Charity campaigns for pregnant women to be fully informed about GBS during routine antenatal care and for GBS-specific testing to be freely available.

Group B Strep Support wants:

Every pregnant woman to be given information on GBS as a routine part of antenatal care.
Every pregnant woman whose baby is at low-risk of developing GBS infection to be offered an ECM test for GBS carriage at 35-7 weeks of pregnancy (and where these are not available from the hospital, the women should be told how to access them privately)
Every pregnant woman whose baby is at higher risk of developing GBS infection (where one or more of the risk factors listed above are present) to be offered intravenous antibiotics from the start of labour until birth and, where the babies are at highest risk, for these antibiotics to be recommended.

Jane Plumb MBE, Group B Strep Support’s Chief Executive, says, “We believe this is the best approach for preventing GBS infection in newborn babies in the UK. It is so important that pregnant women are informed about GBS and consider testing.”

Group B Strep Support campaigns for greater awareness and better prevention of GBS infection in newborn babies, including offering the simple and safe ‘Gold Standard’ ECM test to every pregnant mum.

Jane Plumb MBE adds, “Sadly, we continue to hear from and offer information and support to families who have suffered as a result of GBS. As one mother put it, “I can’t explain the pain; it’s not something that I could ever imagine feeling ever again. I don’t know anything that compares.”

Sarah Jane Chapman has created a petition, ending on 31 December 2013, asking The Department of Health to ensure women are routinely offered testing for group B Strep in every pregnancy. Please read it at http://epetitions.direct.gov.uk/petitions/43712 and consider signing it, and sharing it with your friends and family.

July is GBS Awareness Month – A Simple Test to Save a Life – and Group B Strep Support will be urging pregnant women to get informed about GBS and consider testing.

For further information about group B Strep, visit the Group B Strep Support website at www.gbss.org.uk or call 01444 416176.

July offer – ECM testing pack for £29

Vaccine Transport and the 2 to 8 Cold Chain

A cold chain is a logistic system that provides a series of refrigerating facilities aimed at maintaining certain goods at a pre-requisite, constant (usually low) temperature from the point of production to the point of sale or usage. Proper execution of cold chains is vitally important to many different industries, including the food, pharmaceutical and the chemical industries. Any product that needs to be maintained at a constant temperature in order to retain its optimal effectiveness requires the use of a flawless, unbroken cold chain. Using temperature indicator labels will assist in the monitoring of this process.

The role of a cold chain is vital to the industries it serves. An effective cold chain will increase product longevity, nullify contamination and bacterial infestation, and minimize waste and expiration of stock before it can be delivered or sold. A high-quality cold chain also helps to improve product reliability and to ensure customer satisfaction.

The most common and widely implemented cold chain is in the temperature range of 2–8°C, as this range is used in preservation and transportation of a wide range of goods, from food to pharmaceuticals. This mandates that the temperature be maintained above 2°C and below 8°C at all times. If it fluctuates outside of this range it will render the product unusable.

A cold chain may consist of several different types of facilities for storage and means of transportation. It may include pre-cooling facilities, cold storage facilities for warehousing, refrigerated carriers (such as trucks or rail cars), thermally insulated packaging and the kind of information management system that is required to monitor, track and trace a certain product.

Monitoring a product’s temperature constantly while in transit is absolutely critical in order to prevent the product from losing some of its properties. For example, frozen foods may not remain edible if exposed to higher temperatures, even if only for a brief period of time. In the pharmaceutical industry, for example, a constant temperature is essential for keeping certain drugs from losing their effectiveness, or even worse, from becoming poisonous.

Transporting vaccines to remote areas, particularly in Third World, poverty-stricken regions where transportation may not have been adequately developed, is extremely difficult. Making sure the drugs stay refrigerated throughout what may be a very long haul, with zero temperature breaches, is absolutely critical. In such cases the importance of proper monitoring equipment rises exponentially. Vaccines are most needed in tropical regions because viruses thrive in hotter climates. In extreme heat, the shelf life of several drugs and vaccines is reduced dramatically as compared to colder, more sterile climates.

Another problem with temperature-controlled transportation that has recently come to light is that some refrigerator-truck drivers have been known to turn off the refrigeration while driving at night or while taking a break. This makes good economic sense to them because refrigeration is expensive in terms of energy consumption and fuel costs. As long as the goods arrive at their destination at the required temperature, there is no way for customers to know whether or not there has been a temperature breach. This kind of malpractice can render vaccines useless and even endanger lives on a massive scale.

This is where proper monitoring equipment comes in. Temperature monitoring labels and indicators let customers know whether or not there has been a temperature breach. Some of these products, like Timestrip, run battery-free and can be transported and stored at any temperature range, making them very cost-effective and easy to use. They are built to be tamper proof, so, once activated, they will provide a faithful, unbroken log of the temperature ranges that they’ve travelled through without deviation. They also will let a customer know how many breaches in temperature may have occurred. Such products increase the overall reliability of vaccines and may help to save lives in the long run.

The Pharma Cold Chain

In the pharmaceutical industry, proper execution of unbroken cold chains can be vitally important. There are many drugs and medications that must be maintained at particular temperatures in order to retain their maximum effectiveness. In storage this is not difficult, but it becomes an issue when transporting such pharmaceuticals to their intended destinations. For example, transporting vaccines to high temperature areas via poorly developed transportation networks can, if not done properly, render them useless. For this reason having the right equipment for your cold chain is vitally important. And today one of the must-haves for effective cold chain logistics is the Timestrip line of time and temperature indicators.

Timestrip makes small compact indicators with temperature sensitive labels that help you keep your temperature controlled transport needs under control. Their line includes four different types of time indicators: Timestrip, TimestripPlus, TimestripMinus and the brand new Timestrip Complete. Timestrip, the first product developed by this company, is a simple indicator that measures elapsed time. For temperature breaches, the Timestrip Plus indicator measures ascending temperature and the Timestrip Minus measures descending temperature. The Timestrip Complete combines both of these features.

Timestrip’s indicators depend on a patent-protected process involving the migration of a dye along a membrane. The indicators are completely inert prior to activation and are stored and shipped at room temperature, which makes them extremely cost effective compared to other cold chain technologies for products that require handling at very specific temperatures. Once the indicator is activated, it begins the measurement and elapsed time or temperature breaches are displayed clearly on its surface. Once activated, these indicators cannot be stopped or turned, making the entire process tamper proof.

The temperature breach indicators TimestripPlus and TimestripMinus are both exceedingly popular in the market. Not only do they tell you that a temperature breach has occurred, but also for how long the product was exposed to unhealthy temperatures. In the case of multiple temperature breaches, they will tell you the duration of each individual breach, as well as the cumulative duration of them all. They are highly accurate and come tailored to a variety of temperature thresholds, so you can choose the best option for the product you need to transport.

Chilled products with thresholds of 5°C, 12°C, 18°C and 23°C and frozen products with thresholds of 0°C and -14°C are all serviceable by the TimestripPlus, while the TimestripMinus is tailored to measure temperature breaches below a threshold of 2°C. And the brand new, groundbreaking Timestrip Complete combines the best of both by measuring temperature breaches outside a given range, both ascending and descending, in order to service the 2–8°C cold chain requirements which are among the most common and that are vital to the pharmaceutical industry. It provides complete, true 2–8°C temperature monitoring in a single product for the first time in the history of the industry.

Other benefits of Timestrip indicators include that they are water resistant, can be stored and shipped at any temperature, are environmentally friendly, have a long shelf life and are extremely cost effective. Whatever you’re pharma transport needs, if you need to keep a close eye on your shipped products, Timestrip UK Limited are definitely the go-to guys for the job.

Cold Chain Hub

a forum for Cold Chain professionals