Importance of Monitoring Pharmaceutical Storage Temperature
Ensuring proper storage of pharmaceutical products, in accordance with the manufacturers’ specifications, is crucial for the stability of products. The conditions should be consistent throughout the cold chain. Poor temperature control undermines the efficacy of the drugs. Improper storage conditions at the warehouse or in transit can cost thousands in wasted product.
The Healthcare industry is expected to deliver high-quality products to their patients. Monitoring of the climate in the storage of pharma products is important to ensure the safety and consumer well-being. Controlled storage temperature plays an important role in this.
Monitoring Pharmaceutical Storage Temperature Ranges
Each medication has a recommended storage temperature and humidity. The manufacturer will provide specific parameters at which the product should be stored. Adherence to this guarantee their quality and to provide the intended efficacy.
There are several categories for the temperature ranges of medicines:
- Non-refrigerated medicines. Stored at ambient temperatures between 10°- 25°C. Usually labelled keep under 25°C, though some are stable up to 30°C
- Refrigerated medicines, including vaccines. Stored between 2°-8°C to maintain efficacy. Strict temperature control required. Any breach of the cold chain could lead to discarding the pharmaceutical product.
- Freezing temperatures between -10°C to -25°C. Necessary for specific drugs and vaccines such as Zoster, Varicella or MMR.
Pharmaceutical products safety
Improper temperature storage may have different effects on the medications and drugs stored. If temperatures are out of range by a few degrees Celsius their chemical stability can be affected. Worst case it can alter a drug’s physical properties. This can have dangerous consequences when administered to patients. The pharmaceutical products are tested and analyzed as to how long they can withstand exposure outside of the prescribed temperature ranges. This is known as the drug stability budget.
Live virus vaccines tolerate freezing temperatures but rapidly deteriorate after removal from storage. Damage to inactivated vaccines occurs when exposed to temperature fluctuations. It is crucial that the proper storage and handling are adhered to.
There are specific procedures that should be followed when a violation of storage temperature for vaccines occurs.
- Immediately isolate the vaccines and prepare them for storage between +2°C and +8C.
- During storage label them “Do Not Use”
- Contact the manufacturer for advice
- Determine if anyone has received a compromised vaccine
Monitoring Pharmaceutical Storage Temperature – Best Practice
The W.H.O provides guidelines for good storage practices of pharmaceuticals. It is recommended that the recording of storage temperature data is kept for quality assurance review. The data should be kept on file for at least the shelf-life of the stored product +1 year. Some national legislation may require longer.
The Australian Government department of health published a chart that should be filled in twice a day. Manual temperature checks and plotting on the chart is a time consuming and error-prone task. When the temperature is out of range, it is unknown for how long the condition has existed since the last check.
Temperature monitoring systems should be installed to monitor the cold storage environment. The system should also be capable of logging data and producing reports and graphs. Monitoring and alerts when abnormal conditions occur can save thousands in lost product.
Warehouse temperature mapping should show the uniformity of the temperature across the storage facility. Temperature sensors should be located in areas which are most likely to have fluctuations.
The monitoring system can be wired sensors or wireless sensors. When dealing with cold storage, often the wireless option is preferred. Wireless sensors are easy to install and can operate on batteries.
The below charts are an example of data collected from a monitoring system.
The first chart is from a stable refrigerated storage environment. The temperature fluctuates with the compressor cycles but is maintained within the defined limits.
The second chart illustrates a high-temperature excursion. This can be caused through failure of mainline or backup power systems, or malfunction of the refrigeration system. A temperature monitoring system alerts once the threshold has been breached and the ten[erature excursion occurs. This allows for immediate response to the evolving situation. A power monitoring system on the refrigerator would give an earlier warning of the problem.
Monitoring Pharmaceutical Storage Temperature Throughout the Cold Chain Distribution Network
A crucial time for pharma products is when in transit. The vast majority of temperature excursions that results in discarded product take place during the cold chain distribution stage. During transport, products could be in an unpredictable and uncontrolled environment. Monitoring during cold chain transport and delivery is also crucial. In some countries, it is mandatory for data logging to take place during the transport of temperature-sensitive pharmaceutical products.
Temperature controlled logistics are crucial for product quality and minimize spoilage. SPecialist pharma-logistics companies can be engaged in the transport and cold chain distribution of temperature-sensitive pharmaceutical products. They are properly equipped to handle the product and are familiar with the regulatory requirements for handling and temperature exposure.
Logging of temperature for refrigerated and frozen pharmaceutical products during their transportation provides traceability. Downloaded data is analyzed to verify the maintenance of temperature compliance and that excursions do not exceed the drug stability budget. Temperature data logging gives early detection of degraded lots before reaching patients.
Humidity Control Matters
Additional to temperature monitoring, humidity monitoringhas a role in keeping pharmaceuticals safe. High humidity can cause pharmaceutical drugs to absorb moisture. This can occur during final packaging, shipment or storage. causing certain medications to degrade and lose efficacy. Monitoring humidity levels keep drugs stable through to their expiration dates. Mold growth on packaging can also occur n high humidity environments. Medicines should be in a well-ventilated warehouse. Monitoring aids in maintaining humidity levels of 60 percent or lower.