In the world of medicine, the lives of patients can literally depend upon the safe and effective administration of vaccines. The handling, transport, and storage process is referred to as the supply chain or cold chain.
Precious, high-value vaccines need to be handled with the utmost care throughout the entire supply chain.
There can be no failures along the way! However, there are many challenging factors throughout the cold chain that need to be addressed. Let’s explore some of these transport challenges in further detail.
Challenges for Vial Transport Monitoring
Bulk vaccine shipments to underprivileged countries often encounter a lack of basic infrastructure and safety protocols. These obstacles can pose harmful and dangerous threats. Seasonal vaccines can also encounter logistical problems. In addition, buyers may need to mitigate risks due to government tenders, which can cause added financial pressures.
WHO relies on key partnerships and the cooperation of multiple NGOs for safe monitoring and global distribution of vaccines.
Pandemics are obviously the most demanding, as emergency timelines are considered and decisions need to be made that best serve the public interest. In these cases disaster management often requires government and military involvement.
The COVID-19 global pandemic has placed emphasis on stringent safety measures as the world eagerly awaits the vaccines. Regulators require testing centers and laboratories to monitor the sample testing kits from the point of collection to on-site storage, and during shipment to labs for analysis. Vaccine vials are subject to similar monitoring regulations throughout the entire distribution chain.
ELPRO is a highly-trusted global supplier to the pharmaceutical, biotech, life science, and healthcare industries since 1986. The company designs effective hardware and software monitoring solutions incorporating cloud database technology that ensures compliance with WHO safety standards and protocols.
WHO Prequalified Temperature Monitoring Devices
Prequalified pharma companies are obligated to ensure WHO compliance when it comes to vaccine vial monitoring logistics during storage and distribution in the cold chain. Each vaccine has a specific temperature range. Prolonged excursions outside of the allowable temperature ranges will cause product deterioration. This can lead to a lack of treatment efficacy in vaccine-preventable diseases. Undue light exposure and temperature fluctuations should be kept to a minimum. Efficient and reliable vaccine vial monitoring devices are a prerequisite to ensure the vaccines are constantly being maintained at the correct temperature. This is vital for the safety of the patients.
The WHO established strict rules and regulations governing the Standard Performance Specifications for cold chain equipment thus ensuring vaccine stability. The first guidance documents considering the cold chain’s status were issued in the 1970s. The WHO’s monitoring safety standards prequalifies devices such as vaccine vial monitors, vaccine data loggers, electronic shipping indicators and chemical indicators. In this regard, the WHO counts on the close partnership and cooperation of multiple NGO’s such as UNICEF, PATH and CARE International for safe monitoring and distribution.
Vaccine vial monitoring errors can lead to spoilage and the need to re-vaccinate. They can also result in the loss of confidence from patients, and significant cost. It is actually advisable not to vaccinate, rather than administer a dose of mismanaged vaccine!
Find the Right Monitoring Solution for Your Vaccine Transport
Standard Operating Procedures
The WHO Performance, Quality and Safety (PQS) process screens vaccine vial monitors, so that member countries and purchasing agencies forming part of the United Nations are assured of their worthiness in immunization programs. The PQS operation encourages manufacturers to apply for prequalification, as this facilitates a competitive marketplace.
The implementation of WHO PQS is governed in accordance with a set of published standard operating procedures.
Several categories for WHO pre-screening include temperature monitoring devices, transport guidance, cold and freezer rooms, refrigerated vehicles, refrigerators and freezers, insulated containers, cold boxes and vaccine carriers, waste management equipment, specimen collection equipment, coolant and warming packs, cold chain accessories, single-use injection and therapeutic injections.
WHO operational procedures include ordering and accepting deliveries, inventory control, correct labelling and packaging, packaging standards, handling of temperature monitoring devices, storage volume standards, shipping and arrival procedures, route and arrival dates, vaccine arrival reports, and disposing of potentially compromised vaccines.
A useful operating plan will require signage to be posted on the storage units indicating which vaccines require refrigeration or freezer storage. For example, liquid vaccines are sensitive to heat and freezing, and normally require refrigeration.
A comprehensive vaccine vial monitoring routine considers the recommended procedure regarding live and inactive virus vaccines.
Obviously, correctly trained and educated personnel are key. A coordinator must be assigned at each facility to perform responsibilities such as physical inspections and logging inventory administration. There must also be experienced licensed vaccinators, as well as medical support staff who assist with vaccine preparation and supply chain management. The Declaration under the Public Readiness and Emergency Preparation (PREP) Act for Medical Countermeasures Against COVID-19 also requires the employment of healthcare providers who handle “observation period” documentation.
National regulatory authorities, in countries which produce vaccines already pre-screened for purchase by UN agencies, have access to a list of contact points. It is imperative to have an emergency vaccine retrieval and storage plan in operation which is easily accessible to staff at every facility. An adequate supply of packing materials capable of accommodating the organization’s full stock inventory should be available to move vaccines if needed. Refrigerated trucks may also be needed to move large batches of vaccine.
WHO PQS Devices Catalogue
The catalogue includes a listing and details of all immunization-related products that are approved by the WHO. The WHO’s approach to product qualification is based upon three main criteria:
The relevant specification standards and performance characteristics must be displayed by the selected vaccine vial monitor.
Safety standards are met and followed ensuring no harm is ever caused to users, patients, or the environment over the entire life cycle of the product.
Must possess reliability and quality features that are suitable when used in field conditions.
The PQS process adopts international standards as its basis for the development, design and production of each type of product. WHO consistently aims to improve their services and make changes where necessary. The focus is to bring the organization into a productive relationship with end users, as well as key partners and industry. The PQS process includes technical specifications and ensures test procedures are accurately executed and reflect operational requirements. WHO monitors each product in the market in order to assess quality, safety and performance. They also base their decisions on frequent reviews and user feedback.
COVID-19 Vaccine Vial Monitors, Data Loggers, and Electronic Indicators Per Scenario
Temperature and cold chain logistics experts understand you simply cannot make errors when collecting COVID-19 test samples. The U.S. Department of Health and the Center for Disease Control (CDC) mandate that COVID-19 samples must always be kept at 2-8 °C and reach an analysis lab in under 72 hours, otherwise the samples should be deep-frozen using dry ice.
ELPRO offers three monitoring solutions that can help ensure your organization is compliant in this regard.
- Solution 1
For doctor’s offices, clinics and small pharmacies: LIBERO W (for refrigeration), LIBERO CB (2-8 °C), and LIBERO CD (dry ice).
- Solution 2
Hospitals, pharmacy chains and drive-through pharmacies: ELPRO Cloud, LIBERO CB and LIBERO CD.
- Solution 3
Electronic (smart) temperature indicator: LIBERO ITS (end-to-end temperature indicator on kit/tray).
Different Types of COVID-19 Vaccines: Storage and Transport
Numerous pharmaceutical companies have announced their COVID-19 vaccines, but they all differ when it comes to the storage and transport requirements. For example, the ideal temperature for the Moderna vaccine is set at -20 °C. Whereas Pfizer is -70 °C and the Johnson & Johnson, UREVAC, AstraZeneca and IDT vaccines are set between 2-8 °C. Hence there are already 3 different temperature requirements.
Vaccines are fragile and require specific temperature ranges to maintained in order to ensure efficacy during storage and transport.
Therefore, following the SOPs of the manufacturers is critical to ensure the efficacy. Setting up conditions and equipment which maintain -20 °C temperature may seem fairly easy. However, you don’t find many large temperature-controlled facilities in the pharmaceutical supply chain favorable to managing this particular temperature range and the massive volume of vaccines. So, a temporary solution may be a vacuum-sealed container with phase-changing material with melting point at -20°C, with a PDF data logger to monitor the conditions. Moderna says its vaccine can be stored and transported at 2-8°C for the last 30 days.
The Pfizer vaccine originally required storage and in transit temperatures of -70°C. You will need specialized equipment for this, namely an ultra-low freezer or dry ice containers capable of holding multiple doses and enduring air freight, shipment, and local distribution channels. Containers featuring special vacuum-insulated panels suitable for extreme cold, phase-change materials, as well as ELPRO data loggers which monitor the containers wirelessly via Bluetooth® transmitting the data to the cloud.
The existing infrastructure at hospitals, pharmacies and wholesalers with storage facilities and vehicles which handle the 2-8°C temperature range is well established. However, ad hoc infrastructure is needed for pop-up vaccination centers which require special transport containers, additional storage and extra refrigeration. This ad hoc inventory will still need to be qualified, temperature mapped, and monitored. In this situation, you can work with various data logging devices including ELPRO PDF Bluetooth® data loggers, box-level electronic smart indicators, and LIBERO G real-time mobile IoT devices which provide temperature, humidity and location data.
Some examples of vaccine vial monitoring devices to consider are the ELPRO LIBERO ITS, ELPRO Cloud wireless monitoring solution and the LIBERO W wireless PDF data logger.
Monitoring Vaccines During Shipment
Shipping temperature sensitive products is no easy task. However, the work is easier when you have the right temperature monitoring device and software. You can manage the temperature of your shipment with ELPRO’s smart equipment, such as the LIBERO CE multi-use Bluetooth® PDF data logger. It can monitor products within a temperature range -200 °C to +400 °C. For cryogenic shipments, the LIBERO CS single-use PDF data logger for frozen shipments from -30°C to +70°C is ideal. The LIBERO CD single-use PDF data logger for -95 °C to +50 °C is suitable dry ice shipments.
End-to-End Kit or Box Monitoring
You can choose to use various devices to monitor vaccines throughout the cold chain or just one device that replaces them all – the LIBERO ITS. It eliminates the complexity of using multiple temperature recording devices such as freeze indicators, data loggers and electronic indicators for your vaccine shipments. It is a smart indicator that allows you to download statistics, and is WHO, IATA and NIST compliant. LIBERO ITS electronic indicators – WHO TYPE 1&2 (automated or hand-applied to kits or trays).
The stakes are high when it comes to the protection of vaccines, when the real price to be paid is the difference between life and death. ELPRO ensures comprehensive environmental data monitoring solutions and GxP services, providing peace of mind that critical procedures regarding vaccine vial monitoring are safe, effective and compliant. After all, our true wealth is our health.