“Need to set up cold chain for COVID-19 vaccine ASAP”

Korea Pharmaceutical Distribution Association opens the third ‘Pharmaceutical Distribution Development Forum 2020’

Professor Lee Jae Hyun introduced a vaccine cold chain guideline covering the vaccine storing and distribution

Professor Lee Jae Hyun

“Pfizer and Moderna both use mRNA type of COVID-19 vaccines and it is a highly unstable substance that requires exceptional level of cold chain management.

 

Especially, the response plan on how to react on an emergency, for instance malfunctioning storage tool or power outage, is the most important part.” A Sungkyunkwan University College of Pharmacy professor, Dr.

 

Lee Jae Hyun said as above on Dec.

 

21 at the Korea Pharmaceutical Distribution Association (KPDA) ‘Pharmaceutical Distribution Development Forum 2020’ that opened a discussion on the current pharmaceutical cold chain in South Korea and related solutions.

 

As the number of biological drugs like vaccine is climbing, the drug distribution industry has to inevitably take account of cold chain.

 

More specifically, Pfizer and Moderna have developed COVID-19 vaccine based on the novel technology using mRNA, which demands highly intricate control of the environment.

 

However, only a handful of companies in the South Korean drug distribution industry has a cold chain for general biological medicine, not even suitable for the mRNA vaccine.

 

Also at the forum, the chairman of KPDA Cho Sun-hye said, “Because the core of our industry is pharmaceutical distribution, we must achieve the hegemony in cold chain.

 

And this forum was organized to swiftly and preemptively establish infrastructure for the cold chain market, and to prepare ourselves for the changes.” A cold chain is an environment with overall temperature control used to store and distribute biological drugs at its optimal state.

 

The most integral part of cold chain is maintaining the optimal temperature for the entire process of distribution.

 

Professor Lee Jae Hyun introduced a vaccine cold chain guideline and explained of the vaccine storing and distribution the industry is paying a close attention to these days.

 

The professor elaborated, “The primary factor is to set a system that defines how to handle storing and shipping when using cold chain, what type of transportation cradle would be prepared and how to get to the destination.

 

And also a validation system is needed to confirm the preparation of the system.” Dr.

 

Lee stressed the cold chain has to be ready to handle emergency situation like malfunctioning and power outage.

 

Moreover, a supply manager and quality control manager should be appointed to document the vaccine management criteria according the Good Distribution Practice (GDP).

 

A wholesale manager can personally check the vaccine shipment, but a separate vaccine management staff should be designated with a proper training to react appropriately and timely to an emergency situation.

 

A general prerequisite of a vaccine cold chain storage is a space that can maintain an adequate temperature and level of humidity.

 

Refrigerated storage or a deep freezer has to use a biologic-specific fridge with an automatic thermostat.

 

The professor highlighted, “Vaccine’s stock can vary depending on the season, but a distributor should have a sufficient space to manage all stock and more for the needed equipments.” The storage equipment has to be strictly maintained regularly, and it has to be kept clean all the time to ensure there is no dust on the heat conducting coil or motor.

 

The storage equipment has to be validated for its adequate temperature via temperature mapping, which confirms well distributed target temperature in all spaces by using the temperature sensor and finding the maximum and minimum value.

 

Professor Lee said, “Although an expert specialist can be hired to maintain the storage, especially for temperature and humidity, environmental hygiene and protection against pests and weather, the wholesale distributor would be held responsible so the company should visit and check the site regularly.” As soon as vaccines arrive, they would be moved to the storage immediately.

 

And the staff in charge would have to record the arrival date and time, the name of acceptor and maintenance staff, the state of the vaccine with the corresponding solvent at the time of arrival, the name of vaccine accepting company, type and volume of the vaccines, and manufacturing serial number and expiration date.

 

Professor Lee added, “For the thermostat in the vaccine cold chain, I recommend using a thermostat with tuning certification.

 

And in case of temperature fluctuation issue caused by aged equipment, the temperature record should be archived for over two years at least.”