InterviewIssueNov 21

A solid and efficient cold chain system is critical to deliver current vaccines

Sanjay Jain, Director, Elanpro

 

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Optimal cold chain infrastructures are vital if vaccines are to reach healthcare facilities at temperatures where their efficacy remains unchanged. Could you tell us about the cold chain infrastructure available in India?

The cold chain network in the country has been the backbone to ensure storage at different stores and supply of vaccine between the nodes of storage and to the outreach sites at the recommended temperature for administration to the target population. Further to this, due to the rise in vaccines due to the global COVID-19 pandemic, the Indian cold chain market reached Rs 1425.49 billion in 2020.A solid and efficient cold chain system is critical to delivering current vaccines at high quality and prepare the routine
immunisation/vaccination system to accommodate newly available vaccines.

Currently, the majority of the cold supply chains in India are in the range between 2-8°C. Even though we have one of the largest immunization and vaccination programmes in the world with the budgets of more than $500 million every year, the Indian infrastructure has visible evidence gaps in the following:

• Lack of primary data in cold chain status in India based on which the projection for vaccine storage space and dry space can be developed
• Lack of primary data on quality of temperature maintenance at the cold chain points
• Lack of primary data on the determinants, barriers related to immunisation/vaccination logistics and opportunities for improving the system
• Lacks systematic analysis on the requirements for expanding its cold chain for future adoption of vaccinesFocusing on reducing this gap, the Ministry of Health and Family Welfare in partnership with UNICEF developed the web-based National Cold Chain & Vaccine Management Resource Centre to monitor the cold chain system real-time setting across the country.

The tool helps in planning and taking management decisions based on real-time information, as a monitoring tool for current equipment status, as a repository of cold chain equipment for the country, and as a platform for future innovations in cold chain and vaccine management.

The COVID-19 pandemic has not only highlighted the disparities in vaccine rollouts around the world but the logistical hurdles that can arise when transporting and storing medical equipment at ultra-low temperatures. Could you elaborate on these challenges?
Vaccine wastage is defined as vaccines discarded, lost, damaged, or destroyed according to the WHO. There are two phases where vaccines are exposed to wastage – opened and unopened vials.
Unopened vials are mostly wasted due to expiration, heat exposure, and incorrect inventory, and open vials are primarily wasted through contamination. Even though a certain amount of wastage is expected given the nature and complexity of vaccine campaigns, the annual vaccine report by WHO reveals an estimate of as much as 50 per cent of vaccine wastage across all vaccines every year. COVID-19 vaccines alone are estimated to record a wastage of approximately 70 million doses by the end of 2021. This data is quite alarming considering the ongoing pandemic and the fact that we have advanced technologically yet face such gaps in the healthcare system.

Elaborating on the challenges, the significant issues exposed were in the following aspects of the vaccination system:

Inadequate vaccine storage system

The vaccine storage system has always been a considerable concern about the wastage of vaccines to a substantial number. Every vaccine comprises different temperatures, and the grave
issue is inadequate and inefficient vaccine freezer and cold storage units.

Inappropriate transportation system
Every vaccine has a different set of compatibility that must be maintained throughout the transportation process. Two major factors during vaccine transportation that can jeopardise drug safety are vibration and shock, which can either alter the vaccine chemically or shear off part of the molecule, reducing its efficacy. About 50 per cent of the vaccines are locally or regionally distributed and widely transported via road, making the chain’s overland transport system a crucial part. While it is cost-effective and can reach remote locations, the biggest issue is maintaining the temperature and safety of the drug. For places with improper roads and infrastructure, transportation becomes a grave issue. Air cargo is also one of the essential parts of any global vaccine drive through its established global time- and temperature-sensitive distribution systems. However, this cannot be attained successfully withou proper temperature control mechanisms and a fully trained staff to manage the uploading and offloading of the drugs.

Environment Control/Logistics
Environmental parameters are critical for any vaccine, as exposing them to incorrect temperature and humidity levels can lead to depleting drug efficiency and efficacy. In the case of COVID-19 vaccines which are highly temperature sensitive, frequent monitoring of these vaccines is of utmost importance to reduce any vaccine wastage or its efficacy.

Lack of trained staff
Vaccine storage and transportation requires a definitive set of skills and manpower to ensure a safe, reliable and efficient vaccine drive. A lack of skilled and trained personnel is one of the crucial aspects that need to be addressed holistically. Hence, proper training, ensuring staff’s safety and following mandated requirements for storage facilities and transportation needs be on the list of priorities.

What sets Elanpro’s refrigeration units apart from similar products on the market?
Elanpro has been providing various high-end solutions for the pharmaceutical sector. At the beginning of this year, we at Elanpro launched two portable COVID Vaccine Freezer – an IoT-Enabled Portable COVID Vaccine Freezer with a temperature range from 2⁰ C to -20⁰ C and a Portable COVID Vaccine Freezer maintaining temperature only at – 86⁰ C. Designed to store and distribute vaccines at maximum strength and effectiveness to hospitals, clinics and pharmacies, Elanpro’s IoT-enabled Portable covid vaccine freezer is a versatile product. The newly launched product is lightweight and can be installed easily. Additionally, the freezer can also be used for other vaccines. Another beneficial feature of the product is that it can easily be converted into a refrigerator. We have also developed a remote-data monitoring device ‘Thingy(y)’ in response to the Indian industry’s inadequate and unmonitored cold chain.

This temperature-monitoring system is not only cost-effective but also allows the user to receive an alert when there is a change in the temperature. Currently, only a small percentage of the cold chain used for immunisation in India is being checked for potential breaches. As a result, the device collects data from a variety of sensors and aids in real-time decision-making.

What key challenges have you experienced related to transporting vaccines in in-hospitable regions?
Considering India’s geographical challenges, the manufacturers also emphasise bringing a strong ecosystem and developing products that will reduce any longer complexity. The most important aspect and a challenge to affect is precise temperature management. Vibration and shock can either modify the vaccine chemically or shear off part of the molecule, lowering its efficacy. These are two key variables that can risk drug safety during vaccine delivery. As a result, the mode of transportation plays an equally vital role in limiting vaccination toxicity. Around half of the vaccines are distributed locally or regionally and largely delivered by road, making the network’s overland transportation system a critical link. While it is cost-effective and can reach remote regions, maintaining the drug’s temperature and safety is the most significant challenge.

Also, transportation becomes a major concern in areas with poor roads and infrastructure. Aside from storing the COVID-19 vaccine, what are some other existing or potential applications for ultra-low temperature freezers in healthcare?

Ultra-low temperature freezers usually have a temperature range of -45 degree C to -86 degree C. These freezers are used in blood banks, hospitals, epidemic prevention services, research institutes, and biomedical engineering facilities, among others. Additionally, other than COVID-19 Vaccines, these freezers are also used for the storage of tissue samples, enzymes, bone marrow and other biological materials in laboratories. There are several designs for ultra-low temperature freezers which vary depending on how much storage is required.

Can you tell me about some of the work that Elanpro has been doing alongside policymakers and national authorities to ease the rollout of the COVID-19 vaccine?
Elanpro has rolled out the complete range of vaccine refrigerators and freezers and also portable freezers for outreach programmes so essential for time-bound coverage of the masses without real investment in the infrastructure. Apart from that, we are also performing on a baseline by improving the infrastructure in upgrading people’s skills. Understanding the region and its requirements, we’ve gone ahead and designed refrigerators that will work on solar energy, kerosene or LPG. For instance, a village near Cherrapunji, experiences rain most of the time of the year, and hence, a solar-powered refrigerator won’t work but kerosene or LPG would Additionally, this product is embedded with a dual technology that is depending on the requirement one can switch to kerosene or LPG and it’ll still maintain the temperature.

Is it possible that the distribution and supply programmes put in place for the COVID-19 vaccine could be implemented when devising immunisation campaigns against other diseases?
Yes, it is possible and it is necessary to learn from the COVID-19 vaccination drive. Recognising the gravity of the problems, the government and corporate sector have examined the ecosystem and are working to develop solutions that will not only have broader implications but also provide effective outreach. In India, the vaccine storage system has always been an enormous concern pertaining wastage of vaccines to a considerable number.

Every vaccine consists of various temperatures and therefore the grave issue that exists in India is insufficient and inefficient vaccine freezer and cold storage available here. Vaccine storage and transportation, however, requires a definitive set of skills and manpower to make sure a secure, reliable and efficient vaccine drive. The scarcity of skilled and trained personnel is one of the crucial aspects that require to be addressed holistically. Hence, proper training, ensuring staff’s safety and following mandated requirements for storage facilities and transportation needs get on the list of priorities. Additionally, the pharmaceutical and healthcare industries’ futures are being defined by their adoption of new technology.

In response to this outbreak, there has been a considerable increase in demand for tech-enabled goods that are both effective and efficient. As a result, items such as biomedical freezers and cold chain storage are in high demand. According to the healthcare and pharmaceutical industry, using technologies like AI and IoT seems to be the foremost promising which can not only streamline the accessibility but also enhances the automation process so that there’s less human intervention. AI and IoT enabled devices also allow user to receive a timely alert if there’s any variation in temperature, humidity or pressure.

What should consumers look for to ensure that they are purchasing a high-quality refrigeration solution which is compliant with the appropriate regulations?
Medical freezers and refrigerators are guided by CE (Medical Device Regulation (EU) 2017/745 and Medical Device Directive 93/42/EEC, and all the medical devices are therefore labelled with the CE or CE0123 markings if Class I or Class II respectively) or USFDA, these are important to ensure that basic qualities and temperatures are maintained. This becomes all the more important in the absence of any BIS standards in India. The standard covers specifications such as dimensions, equipment’s used, temperature ranges for commercial refrigerator manufactures and sold in the country. Consumers looking for the product should ensure that the product is compliant with the CE and USFDA standards. Bureau of Indian Standards.

Additionally, buying a new commercial pharma refrigerator or replacing the existing one, is of utmost importance for a consumer to pick the right product which caters to the users’ requirements.

Below are a few aspects to be considered in buying commercial refrigerators:

Temperature Monitoring System

It is essential to consider that the refrigerator/ freezer has a temperature monitoring system ensuring that your commercial refrigerator is keeping products at the correct temperature. Every product requires a different set of temperatures. For instance, in the healthcare sector – a blood bank refrigerator does require a particular temperature to store the blood bags. In terms of vaccination storage, every vaccine/injection requires a particular temperature for storage. Cancer drugs, AIDS drugs, and IVF drugs are precise temperature drugs that can’t be stored in a domestic refrigerator. Hence, it is a necessity to store these bio-medical drugs in bio-medical refrigerators toensure the effectiveness and efficacy of the vaccine.

Efficient and Timely Servicing/ Maintenance

Commercial refrigerators are designed to offer précised performance, efficiency, and durability. Hence, on a timely basis, the unit requires cleaning and maintenance. An efficient and certified technician can help the unit to again function properly.

Appropriate interior dimension or size – Depending on the need or requirement the storage unit to be selected preserving the necessary products/bio-medical drugs Energy Efficient Unit – It is important to have units that comprise energy efficiency ensuring quality and are yet affordable

Tech-enabled features and technology
Artificial Intelligence (AI) is paving its way in this segment aggressively and have been useful in keeping track of the temperature and its quality Today, brands are focusing on producing high-quality units which are embedded with user-friendly technology and are available at a reasonable price.

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