An Overview of Pharmaceutical Temperature Monitoring
Pharmaceutical temperature monitoring is an essential feature of pharmaceutical supply chains, helping to ensure that pharmaceutical products administered to patients are unaffected by temperatures that can alter their efficacy. Because it is so vital in ensuring patient safety, temperature monitoring is a regulatory requirement for the transportation and storage of pharmaceutical products, and a critical component of proper temperature control.
Let’s explore why pharmaceutical temperature monitoring is so important, the typical required temperature ranges, some common temperature-sensitive products, and best practices to comply with regulations.
What is Pharmaceutical Temperature Monitoring?
Pharmaceutical temperature monitoring is the process of using highly accurate sensors to track and record temperature conditions encountered by pharmaceutical products during distribution. By documenting that medicines’ specific temperature ranges were maintained, pharmaceutical temperature monitoring provides assurance that products are safe to administer.
The pharmaceutical temperature monitoring process takes place across the entirety of a product’s journey from the moment it leaves its manufacturer, including storage, handling, and distribution. Temperature monitoring solutions over this process can be broadly separated into two categories: stationary and in-transit.
Why Pharmaceutical Temperature Monitoring Matters
Maintaining the proper temperature throughout the lifecycle of pharmaceutical products ensures their efficacy and safety for patients. Temperature monitoring demonstrates to regulatory bodies that pharmaceutical products were kept at their proper temperatures without being exposed to conditions that could affect their stability. Here are some reasons why it matters.
Maintain Product Efficacy
Pharmaceutical products must always be maintained at their label-stated temperature conditions to ensure they remain effective when used. Exposure to temperatures outside of a product’s label claim or stated temperature range can lead to degradation and loss of potency, rendering the medication ineffective or unsafe. Cold chain monitoring assures stakeholders and regulators that pharmaceutical products have not been exposed to damaging temperatures after leaving their manufacturer as a finished product.
Comply with Regulations
Adherence to pharmaceutical temperature monitoring guidelines is critical for regulatory compliance. Although the specifics of regulations can differ from region to region, pharmaceutical companies are always expected to accurately monitor temperatures during transit and storage to ensure products have been maintained in proper conditions.
Pharmaceutical temperature monitoring must be conducted using highly accurate monitoring devices designed for life sciences, and the data from these devices must be stored in a secure system of record. Non-compliance can lead to serious consequences, including product recalls, significant fines, and damage to a company's reputation.
Reduce Costs
Utilizing digital temperature monitoring can provide actionable data that can be used to reduce costs. Some of these costs reductions are realized through preventing temperature issues – products facing such issues are discarded and undergo a costly remanufacturing and resupply process. Audit-ready monitoring solutions can provide additional cost-savings by helping to avoid non-compliance penalties.
Real-time monitoring with IoT devices can provide further return on investment, providing alerts the moment issues arise, which allow interventions to save medicines and faster resupply when product cannot be saved. Detailed time, temperature, and location data can identify where and when problems occurred, allowing future improvements. Automatic data synchronization reduces the time spent gathering and downloading monitor data, providing the quality team the temperature breach information they need to release products faster at each stage of distribution.
Typical Temperature Ranges
Each pharmaceutical product has a proper temperature range within which it must be maintained. Typical temperature ranges include:
Cold/Refrigerated Temperature Range
Cold storage, or refrigerated storage, ranges from +2°C to +8°C (+36°F to +46°F) and is the most common temperature requirement for cold chain pharmaceuticals. Most vaccines are stored within this temperature range, as well as insulin and many biologics.
Ultra Cold Storage
Some products are highly temperature-sensitive, demanding ultra-cold frozen storage temperatures ranging from -80°C to -20°C (-112°F to -4°F). Achieving and maintaining ultra-cold temperatures requires specialized equipment, including ultra-low temperature freezers and dedicated temperature monitoring devices designed to operate accurately in such conditions.
Room Temperature
Both the European Pharmacopoeia and World Health Organization define room temperature as +15°C to +25°C (+59°F to +77°F). Warehouse environments will often be set at this temperature range, with separate refrigerated rooms and freezers for products requiring colder temperatures.
Controlled Room Temperature
In the United States, many over-the-counter drugs are stored at Controlled Room Temperature (CRT), which the United States Pharmacopeia (USP) chapter <659> defines as between +20°C to +25°C (+68°F to +77°F). Minor excursions are permitted within the +15°C to +30°C (+59°F to +86°F) range, provided they were experienced in pharmacies, hospitals, warehouses, or during shipping.
Cryogenic Storage
Cryogenic storage is an extremely cold temperature storage method, using liquid nitrogen or other cryogenic gases to maintain ultra-low temperatures below -150°C (-238°F). Extremely cold temperatures are crucial for preserving the quality and safety of some biological substances, making cryogenic storage a critical component of biopharmaceutical research.
Examples of Pharmaceutical Products Affected by Temperature
Many pharmaceutical products are sensitive to fluctuations in temperature. Here are some common examples:
Insulin
Insulin is an essential hormone for managing blood glucose levels in people with diabetes. This life-saving medication is usually stored between +2°C to +8°C (+36°F to +46°F). Additionally, many insulin products, such as Lantus pens, can be kept safely at room temperature for up to 30 days after opening. High temperatures or exposure to freezing temperatures can render insulin ineffective at reducing blood glucose levels, putting patients at risk.
COVID-19 Vaccines
COVID-19 vaccines, like the Pfizer-BioNTech and Moderna vaccines, require very low temperatures, around -70°C (-94°F) and -20°C (-4°F) respectively, to maintain their stability and effectiveness. Ensuring these temperatures are maintained is critical to an effective immunization program, and was one of the major pharmaceutical cold chain challenges during the height of the COVID-19 pandemic.
Flu Vaccine
The flu vaccine should typically be stored at refrigerator temperatures of +2°C to +8°C (+36°F to +46°F), a common temperature range for most vaccines. It is important to use proper refrigeration equipment and accurate temperature monitoring to ensure this range is maintained during transportation and storage, as excursions may result in vaccine doses being discarded.
Regulations Related to Temperature Monitoring
Compliance with regulations and Good Manufacturing Practices (GMP) is essential for pharmaceutical temperature monitoring. Here is a brief run through of these regulations and best practices.
GxP
GxP in pharma encompasses various quality standards and guidelines, such as Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Storage Practices (GSP). These documents provide a framework of pharmaceutical best practices, which include proper pharmaceutical temperature monitoring.
USP <1079>
The United States Pharmacopeia (USP) General Information Chapter <1079> outlines risk mitigation strategies for the storage and transportation of pharmaceutical products, with an emphasis on temperature control. This chapter discusses many broad strategies to achieve this control, including personnel training, compliant documentation, and qualification of storage environments and equipment. Additional subchapters provide further detail, including Chapter <1079.3>, which discusses temperature monitoring devices and their proper calibration.
USP <659>
The United States Pharmacopeia Chapter <659> is a regulation concerning packaging and storage requirements for pharmaceutical products. It provides guidance and requirements for compliant thermal packaging, and defines the temperature conditions for the storage and distribution of temperature-sensitive medical products.
State Boards of Pharmacy
In the United States, each state has individual regulations governing pharmaceutical temperature monitoring, which are set by local state boards of pharmacy. As a result, companies must be aware of and comply with requirements for each state in which they operate. Although historically more relaxed than other regulatory bodies, many state boards of pharmacy are now beginning to reinforce their temperature monitoring requirements.
FDA Inspection Observations
As part of its remit to ensure patient safety and product quality, the FDA conducts inspections and records observations of conditions or practices indicating that a product may be in violation of FDA regulations. Observations from the FDA's 2022 inspection data include many issues related to environmental monitoring systems (35 instances), equipment for environmental control (16 instances), storage under appropriate conditions (16 instances), and equipment to control conditions (7).
Best Practices for Monitoring Temperature Sensitive Medications
To ensure effective pharmaceutical temperature monitoring, consider these best practices:
Invest in Real-Time Visibility Solutions
Real-time IoT temperature monitoring solutions use cellular communication to provide live temperature condition and location data while a product is in transit, allowing you to understand where a shipment is and whether proper temperatures are being maintained.
There are many benefits to real-time pharmaceutical temperature monitoring, including immediate alerts in case of temperature deviations, which can enable product-saving actions. Knowing when a shipment has arrived and having its temperature data automatically synchronized to a validated system of record for improved compliance rates are additional benefits.
Identify Risk Areas in Storage and Transit
Areas in your storage and distribution process that are prone to temperature variations can pose a risk to a pharmaceutical product’s quality, so it is crucial to identify them. A thermal mapping study (sometimes called a temperature mapping study) is one common way to do this. Once identified, risk mitigation measures can be enacted to improve your temperature control.
Leverage Data and Insights
Electronic dataloggers provide detailed time and temperature data for an entire trip. When aggregated across many shipments, this data can help optimize processes and provide insight into shipping lane performance.
The additional data collected by real-time temperature monitors provides an even greater opportunity to make better cold chain decisions. Some of these decisions may be relatively minor—using location data to pin down a regular temperature spike to a specific airport cold room and adjusting packaging on that route accordingly—while others may combine monitor data with powerful tools such as Lynx Logix to provide deep analysis of shipping lane risk.
Load Products at the Right Temperature
Vehicles and the thermal insulated packaging used to transport pharmaceutical products should be pre-conditioned to the proper temperature before packing and loading. This prevents a product from being exposed to any temperatures outside of its recommended range at the start of its journey.
Conduct a Temperature Mapping Study
Temperature mapping studies analyze temperatures throughout storage facilities or transportation equipment over a period of time, and are a regulatory requirement. They identify temperature variations and problem areas, recommending proper placement of permanent monitoring sensors for improved temperature control.
Conduct a Shipping Lane Study
A shipping lane study involves analyzing historical data from various routes to understand temperature variations, transit times, and potential risks along a shipping lane. By examining factors like climate, handling practices, and transportation modes, companies can optimize their cold chain logistics. This can help ensure pharmaceutical products maintain the required temperature conditions throughout their journey, minimize quality risks, and enhance overall supply chain efficiency.
Maintain Airflow
Proper airflow and ventilation are crucial to maintaining temperature control, so it is important to pay attention to how products and shelving are arranged. Blockages prevent air circulation, which can cause temperature excursions or fluctuations that can impact product quality.
Develop an Emergency Plan
Emergencies can present a major threat to the quality of pharmaceutical products. A risk-based approach to emergencies may include backup power sources or an alternative storage site, regular maintenance checks, proper protocol for documenting issues and product losses, and detailed procedures for maintaining temperature control during emergencies.
Final Thoughts
Pharmaceutical temperature monitoring is a critical component of the pharmaceutical supply chain. It helps to ensure the temperature control that maintains the quality of pharmaceutical products and documents compliance with regulations designed for patient safety. Adopting best practices in pharmaceutical temperature monitoring benefits patients and the pharmaceutical industry.
Sensitech’s validated temperature monitoring solutions provide user-friendly GxP-compliant cold chain monitoring solutions designed for life sciences. And, if you need guidance with GxP compliance, our professional services team with 30 years of expertise can provide specialized studies, analysis, and best practice recommendations tailored to your specific needs.
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