The Vital Role of Temperature Control in the Pharmaceutical Industry
Being a reliable link in the cold chain requires constant vigilance and precise environmental data. How ready is your facility?
Key Takeaways:
– Elevated temperatures in storage or transit can reduce pharmaceutical efficacy
– Ineffective medical products can endanger patient health
– Digital data loggers allow pharmaceutical stakeholders to better predict and prevent temperature excursions and preserve product quality
– Using multiple digital data loggers at once can provide sitewide temperature snapshots for rapid results
Temperature control and storage monitoring are two pillars of the pharmaceutical industry. Dynamic or static conditions that expose medical products to even a few degrees outside of optimal parameters can cause temperature excursions with three adverse effects.
First, it may reduce product quality, which means patients receive inadequate care. It could also destroy a product’s effectiveness, rendering it useless. Worse, compromised medicines and vaccines could even become dangerous. Read our guide for more about how temperature recording is key to quality control for the pharmaceutical industry.
Temperature mapping done right
Exactly how hot or cold is your facility, its medically related storage spaces, and any associated transport? The precision of your answer reveals how efficiently you’re handling temperature control and storage monitoring. Everything from the smallest refrigeration unit to the largest warehouse must be monitored 24/7, and the information made easily accessible to other stakeholders.
Achieving precision temperature control information is possible using digital data loggers (DDLs), which can be used to monitor and record a wide range of static and dynamic storage environments. The data gathered by DDLs allows for temperature mapping’s essential function – advance planning.
The DDLs reveal the areas most prone to potentially damaging temperature fluctuations that must be rigorously checked. This is followed by two additional best practices. The first is seeking advanced notification of an incoming product and its associated temperature requirements.
Next is staging a preparatory exercise to confirm that all storage and transportation units involved can achieve and maintain the desired parameters without costly excursion. The tests should be repeated annually and reconducted during environmentally variable periods such as season changes.
This data will reveal whether your link in the cold chain (in other words, all temperature-sensitive points from manufacturing to patient use) is strong enough to protect the pharmaceuticals in your care. The best DDLs are perfectly calibrated for the environment they’ll be used in. This reassures stakeholders that the device is certified and has passed rigorous performance tests.
The broader consequences of inadequate temperature recording
The fact that temperature control and storage could potentially save lives is reason enough to implement it. Preventing monetary loss and suffering for providers and patients are other essential reasons. The World Health Organization (WHO) estimates that a lack of temperature control is responsible for up to a 50% vaccine waste rate, hurting people and pharmaceutical budgets.
Patients who do receive vaccines or other medicines that have been temperature-compromised will receive inadequate care and therefore must be given additional doses. This puts a financial burden on the pharmaceutical industry and creates a negative cycle, as increased operating costs are passed on to patients who must pay more for medical care.
The patient may even experience direct physical harm when medical providers don’t monitor product quality. The associated physical, mental, and emotional effects of harm caused by faulty products are grounds for legal action under medical malpractice. Malpractice is “any act or omission by a physician during treatment of a patient that deviates from accepted norms of practice in the medical community and causes an injury to the patient.”
Any medical practitioner who knowingly hasn’t taken the proper temperature control and storage steps for the doses they dispense is choosing to ignore medical recommendations, both from the product’s manufacturer and the Centers for Disease Control and Prevention (CDC). This puts their patients at risk and, beyond the human cost, could result in a malpractice suit totaling hundreds of thousands of dollars or more.
How temperature recording devices help with planning and performance
The CDC recommends that “clearly written, detailed, and up-to-date storage and handling standard operating procedures (SOPs)” be implemented per this vaccine guideline. While vaccine-specific, this resource offers an excellent framework that can be used to model SOPs for any medical facility and personnel handling sensitive pharmaceuticals.
The more data staff have, the more they can follow SOPs. The CDC places the importance of teaching proper storage and handling at the top of its staff training list for new employees and as a refresher for those already in the field. The CDC also recommends that facilities appoint a coordinator responsible for overseeing proper handling and storage. Coordinator responsibilities include:
- Setting up temperature monitoring devices and recording daily temperatures
- Responding to temperature excursions
The following factors are additional CDC recommendations necessary to properly document temperature excursions:
- Date and time
- Temperature data, including min/max readings during the event
- Room temperature
- The length of time the product was affected (if using a DDL)
In all cases of staff training, performance, and data capture, achieving a satisfactory result would be impossible without mapping, temperature control, and storage monitoring to assess and preserve product quality. Marathon Products is proud to supply precision, calibrated devices to help a wide range of industries collect comprehensive temperature data and much more.
Temperature map with confidence
Marathon Products brings over 30 years of industry experience in creating and thoroughly testing environmental data devices for businesses of all sizes. Our ultramodern temperature monitors can help you identify excursions effectively and take immediate action.
Through continuous monitoring, alerts, and notifications calibrated for key variables such as date and time, you’ll never miss a vital development. Our precision microelectronics allow for single-use devices or for hundreds of DDLs to start, operate, and stop in unison so you can simultaneously assess every aspect of your pharmaceutical storage and transportation.
Our sensors go beyond temperature mapping to help our customers monitor humidity, CO2, and vibration levels. We supply solutions to fit every budget, and our experts are available to answer any questions. Contact us at web-inquiry@marathonproducts.com or call 510-562-6450 for more information!