Environment Monitoring in Pharmaceutical Storage

Medical equipment, vaccines, and pharmaceuticals tend to be temperature-sensitive. Therefore, environment monitoring is important in warehouses that store these sensitive devices and medicines. If these items fall outside their required temperature, their potency and quality may be affected. Freezing and heating in vaccines may speed up the decline in their effectiveness.

If the temperatures are not monitored accurately, potentially ineffective medicines and vaccines may be administered since healthcare professionals may be unaware of the current vaccine status.

For pharmaceutical products stored in warehouses, they are required to comply with Medicines & Healthcare Products Regulatory Agency (MHRA) regulations with regard to temperature control. The products need to be stored, transported, and handled under ideal conditions as per product specification.

Pharmaceutical warehouse conditions should be continuously monitored by installing an environment monitoring system where the drugs and vaccines are located. This is important to prevent the drugs and vaccines from deteriorating and ensure their safety for human use.

The monitoring systems to be used should be suitable to the needs of the facility it is going to be integrated into – whether in a small pharmaceutical-store or for an operation with multiple warehousing sites. Whether the organization is a 3PL, wholesaler, or distributor should also be considered when choosing an environment monitoring system since every operation will have varying monitoring and reporting requirements.

Large pharmaceutical warehouses often have elaborate setups with various storage areas. They often have mezzanine floors, cold storage rooms, vaults and cages, walk-in coolers, refrigerators, and freezers. Due to their complex nature, these organizations require dependable and flexible environment monitoring systems with hardware specifically designed for industrial site use. Wireless (RF) sensor networks and hard-wired sensor systems are often suitable technology for these types of facilities. It is necessary that the chosen system is compatible with the storage environment and can be amended to be applicable to changing needs. The system typically used by these facilities is often a web-based system, hosted and managed by the organization.

For small pharmaceutical storage facilities, an adaptable monitoring system is also required. Small storage facilities often have small cold rooms, limited refrigerators, and freezers for storing time and temperature-sensitive pharmaceutical products. For these types of facilities, a small-scale version of a system used for large pharmaceutical warehouses can be used. Meanwhile, for health facilities or pharmacies, a 30-day temperature recorder can be used.

Regulatory Guidelines

To ensure good storage practice for pharmaceuticals, several guidelines are adhered to by warehouses. As per the World Health Organization (WHO) guidelines, special storage conditions need to be indicated on the label of the products. It also requires that they are monitored, checked, and recorded. Additionally, it states that pharmaceuticals should be stored in dry, well-ventilated premises, at a temperature of 15-25°C. Recorded temperature monitoring data must be accessible for review. It also recommends the regular calibration of monitoring equipment and temperature mapping

Meanwhile, the European Good Distribution Practice (GDP) requires that the necessary equipment and procedures are in place in order to check the storage environment. Similar to World Health Organization (WHO) guidelines, it also requires a temperature mapping exercise to be conducted. After which, the necessary monitoring equipment should be situated in areas that tend to experience temperature extremes and fluctuations. Alarms should be installed to detect possible temperature deviations from the identified conditions. The Good Distribution Practice guidelines also specify that it is necessary temperature conditions are maintained throughout transportation. Means to investigate temperature excursions during transport should be available for review as well. Freezing can have a grave effect on the drug composition and its efficacy may be permanently diminished and lost. It can also lead to toxic degradation, which may be hard to detect by its exterior appearance.

The WHO and European GDP guidelines both recommend the regular calibration of temperature monitoring equipment. This is necessary to ensure that conditions are under control and the quality is maintained. Full compliance with guidelines is necessary. This will ensure the safety and efficacy of the pharmaceutical products. Various reports need to be generated as part of the monitoring and reporting requirements. In order to eliminate the manual steps entailed in generating reports, a continuous monitoring system is needed.

The Challenge

Pharmaceuticals are sensitive to temperature and humidity. The reason for this is the protein usually found in many drugs. The proteins are sensitive to changing environments and are susceptible to temperature and humidity fluctuations.

Testing products for stable performance is often time-consuming. Although material costs tend to be minimal, the overall expense is high in comparison. Due to this, the quality and validity of tests and data are important. Storing a product in freezers or warehouses is equivalent to several millions worth of cash being housed in one location. The expense of using a monitoring system with integrated alarm functions is marginal compared to the total value of the products it is protecting. The use of a continuous monitoring system is a cost-effective solution in minimizing possible huge financial loss.

Using Data Loggers

Using data loggers comply with the European GDP requirements. They provide the necessary monitoring of humidity and temperature for pharmaceuticals stored inside a warehouse. Data loggers are able to detect even the slightest changes in temperature and relative humidity. Meanwhile, loggers with external probes have the ability to monitor fridges and hard-to-reach areas. These loggers can be easily placed in a different location and more units can be added as the area to be monitored expands.

Results are detailed and presented clearly. Data from different loggers can be combined for comparison and analysis. For better user comprehension, data is presented in graphs and tables that can be easily printed, copied, and pasted.

Setting up the System

To set up a data logging system, first, temperature mapping needs to be conducted on the storage areas. This will determine the risk areas where the temperature monitoring points will be positioned. The changing seasons need to be taken into consideration since some climates would need to undergo a winter and summer study. It is important for mapping to include locations that tend to have a higher or lower temperature like doors, windows, and the south side of the building. This mapping should be executed before the facility is put up online. Should there be a need for significant changes due to mapping data, it will require the mapping exercise to be repeated.

Second, after identifying the warmest and coldest areas from the mapping, a permanent temperature logging needs to be installed at the identified risk spots. The exact number of logging points will vary with respect to the amount of identified risk points.

Choosing the right Data Logger

A large number of loggers may be needed after the temperature mapping of a warehouse. A basic entry-level logger may be able to fulfill this function. These loggers can be left to record specific areas and transported as needed. The recorded data from these loggers are then used to provide the overall environmental conditions throughout the facility.

Standalone loggers can be used for smaller facilities as part of the environment monitoring solution. This is because they are agile and reliable. They also have a long-lasting battery life that can record long periods of time.

As stipulated in GDP guidelines, an effective alarm system is needed. Data loggers often sound alarm warnings if the temperature falls outside the specified range. The team is notified through a flashing red light or an audible alarm box.
Radio Data Logging Systems are more relevant for larger facilities with various monitoring points. It may also be used for situations where immediate central access to readings is required and logging overtime. Radio loggers automatically collect data. It then transmits the data through wireless communications using a receiver. It then becomes accessible for viewing through a PC, LAN, or across the internet. These radio loggers can be used to record data in inaccessible areas without needing to physically access them to download the data. The positions of these loggers can also be changed should there be a need for expansion of facilities. Notifications will appear in the software should the temperature falls outside the specified range. Warnings may also be sent via email and SMS to the concerned personnel to ensure immediate corrective action.

Pharmaceutical Laboratory and Warehouses

Regulatory requirements and good practice determine that environment monitoring in drug storage is critical. Many vaccines and drugs require storage between 2°C and 8C (35.6°F to 46.4°F)

AKCP provides a solution for monitoring temperature-sensitive drugs and vaccines during transport and storage. 2x NIST traceable, calibrated temperature sensors are compared for accuracy once a second. Alerts are sent if the sensor is out of calibration.

NIST4 sensors feature 4x temperature sensors working in 6 pair combinations with calibration checks, providing multiple failovers should a pair be out of calibration.

Reference Links:

https://www.vaisala.com/en/case/continuous-monitoring-pharmaceutical-warehouses

https://www.akcp.com/blog/monitoring-pharmaceutical-storage-temperature/

https://www.geminidataloggers.com/info/temperature-rh-monitoring-pharmaceutical-warehouse

https://kilardar.com/sectors/pharmaceutical/