Warehouse Temperature and Humidity Monitoring System Requirements for Vaccine Cold Chains
Temperature and Humidity Monitoring for Vaccine Storage. Cold chain immunization delivery systems must comply on the World Health Organization (W.H.O) recommended temperature and humidity controls. This is part of the cold chain logistics system for temperature and humidity monitoring of pharmaceuticals. The cold chain must meet the W.H.O standards to keep the medicines at a constant temperature and humidity during the cold chain delivery system.
The Goal for Monitoring Systems.
This article will give recommendations on how to safeguard pharmaceutical products and medicine from damage by the application of the proper electronic temperature monitoring systems. The monitoring systems should be able to define the operational procedures and give data for analysis to optimize the system.
The temperature at which medicines, particularly vaccines, are stored influences the quality of the product. When the temperature and humidity parameters are outside the range of the prescribed conditions, chemical changes occur, which would, in turn, degrade the potency of the pharmaceutical products.
The requirements of the monitoring and surveillance systems depend upon the type of materials being stored. For example; large pharmaceutical warehouses have a composite number of infrastructures with different types of storage areas. These are the primary warehouse, mezzanine floors, vaults, cold rooms, walk-in coolers, refrigerators, and freezers.
The Need for a Dependable Monitoring System.
No matter what system the warehouses use, it must be compatible with the specified recommendations of the W.H.O health guidelines, or whatever local regulatory bodies might specify. It must also be flexible to change as regulations and guidelines are constantly evolving, as are the requirements of modern pharmaceuticals. Ideally, a cloud-based system, used by a central network and controlled by the pharmaceutical companies. Other facilities that can use a monitoring system are the hospitals, pharmacies, laboratories, blood, and tissue banks.
These facilities have specific communication and technical requirements, and system compatibility challenges (e.g. wireless communication) that constantly test the limit of their capabilities.
A good example of a computer monitoring software is the AKCPro Server software. The software provides graphic monitoring to assist in the pharmaceutical’s operations management, control, send alarms based on pre-set parameters and optimization as well as close integration to the AKCP Wireless Tunnel sensor devices. It is also important to ensure that the software complies with FDA 21 CFR Part 11. The temperature monitoring system is critical for temperature-sensitive pharmaceuticals and vaccines.
Steps necessary to have a W.H.O Recommended Temperature Monitoring System.
a. Identify the storage areas and equipment that will be used for storing the vaccines and medical equipment. Make sure the relevant temperature regimes – ambient, controlled ambient, refrigerated, and frozen – are within the required guidelines.
b. Determine hot and cold points of these storage areas and equipment. These ranges can be influenced by seasonal variants. These can affect the integrity of the vaccines.
c. Ensure the warehouse facilities and equipment are up to standards by the W.H.O recommended settings before storing the medicines and vaccines.
d. equip the storage facilities with an automated monitoring system that continuously records and documents temperature and relative humidity parameters at one or more predetermined points. It must be able to send real-time data on the environmental conditions in the different storage areas.
e. Logs to record the impact of the changes in the temperatures of the cold storage units.
Determine Which Centralized Monitoring System Works.
The hosted system: Fully governed by the pharmaceutical company. The server and database are stored, managed, and maintained by themselves, which is also responsible for maintaining the system and preserving its medical potency. For those facilities with limited cold chain equipment, like health-care facilities and small pharmacies, the system will have separate equipment; most likely a simple portable electronic recorder that can be directly read by the person responsible for the cold chain equipment.
Service as a Solution (SaaS): The hardware of the monitoring system namely the sensors and readers are set up at the installation’s site, but the software, server, and database are managed by the system supplier. The data that is stored and managed by the supplier. The company has access to the information through a secure cloud-based interface. With this set-up, the supplier is responsible for the system’s maintenance and updates it with the latest software.
Choosing between these systems is critical. It can have long-term operational and financial effects. The system should be compatible with the needs of the medical company, whether big or small. It is also important if the company is 3PL, wholesaler, or distributor. Each of these has different monitoring and reporting protocols. For example, a hard-wired sensor apparatus may be needed in the large complex like pharmaceutical warehouses whereas in drug stores only a simple refrigeration system with 30-day temperature recorder is needed.
It is vital all monitoring must be observed 24/7/365. Smartphones can receive alarms when a temperature excursion occurs. An electronic sensor installed in the warehouse, cold room or refrigerator will constantly check the temperature and then report any excursions to the appropriate staff. There is no time-off when it comes to life-saving vaccines and medicines.
The system provides temperature records for easy access from any device like a computer, phone, or tablet. The data is collected and analyzed to prevent accidents and setup future procedures to prevent such occurrences.
Sensors should collect and buffer data non-stop, even during network outages and power cuts. The data is then be transmitted to the host server once the connection is re-established. This makes the sensor a data logger as well as part of the monitoring and alarm system.
A sensor accuracy of ± 0.5 °C or better is expected. They should be calibrated annually. An annual calibration procedure for the system sensors should be designed so that it can be carried out without disrupting the monitoring process. Calibration should be performed by a laboratory with NIST traceable calibration certificate provided.
When using web-based monitoring systems, it must be user-friendly even if they perform complex operations. This minimizes training and cuts the time required to operate the system. They function with the Local Area Network (LAN) and Wide Area Networks (WAN), using Transmission Control Protocol/Internet Protocol (TCP/IP) to be accessed by multiple users, buildings, and sites.
With the Web-based systems installed, the staff can trace pharmaceutical products, follow up alarms, and collect data into preformatted reports. Ideally the system should combine audible and visual alarms with electronic messaging systems; the latter allows authorized users to be alerted via email, phone or text (SMS) message.
Choose an Adaptable and Scalable System.
- Easy of configuration for small-scale or large-scale facilities;
- Centralized monitoring of different remote sites
- On-site hosting or cloud-based hosting (SaaS);
- Open architecture which allows future expansion and upgrades
The System Should Include other Features Such as:
- Monitoring other parameters like airflow, pressure, flooding, and movement
- Integrated monitoring of transport systems o refrigerated and temperature-controlled vehicles or vans,
- Automatic detection and monitoring mobile sensors and tags (e.g. radio frequency identification device (RFID).
No matter what is the system is, whether hosted or SaaS, the contract with the supplier must include technical support and warranties for the monitoring equipment.
Areas That Must be Monitored
- All general warehouse venues including distinct zones such as mezzanines and controlled ambient stores.
- Cages, vaults and temporary holding areas, preparation rooms for packing and secured areas where vaccines and medicines are handled and stored.
- Cold chain equipment which is used to store the medical products in a frozen condition like freezer rooms, cold rooms, freezers, and refrigerators.
- Conditioning equipment like refrigerators and freezers are used to store and condition cold chain packaging materials that must be integrated into the monitoring system. Packaging materials include ice-packs, cool water-packs, gel packs, and phase change materials.
Once the system is deployed, the concerned departments in the pharmaceutical company especially the operations, IT, and technical departments must work together with the system supplier to create a joint deployment plan. The accomplishment of this plan must be closely checked as the work near completion.
Once completed, the installer will need to prepare to turn over the system parameters; this includes identifying the people who will have access to it and the alarm settings. The system will be transferred to the company and be oriented to the controls of the system, run tests, and adjusting the alarm parameters.
Only then when all the checkups were performed, certification from the authorized government agencies will be issued to the company.