Pharmaceuticals play an essential role in the lives of millions of people around the globe. To reach these end users, pharmaceutical companies must pass through a complex supply chain. Since many of these products are temperature sensitive and potentially lose their efficacy under the wrong conditions, it’s crucial to store pharmaceuticals in controlled environments.
Crown LSP Group is a leading temperature-controlled warehousing provider for pharmaceuticals and other sensitive products. We understand what it takes to develop cutting-edge warehousing solutions that protect your products while aligning with your business objectives.
What Is Pharmaceutical Warehousing?
The pharmaceutical industry is a global market responsible for researching, producing and distributing prescription drugs and medications. There are currently more than 20,000 approved prescription drugs on the market, with over 6.7 billion dispensed as of 2022. Getting these products into the hands of those who need them is an intricate process, with pharmaceutical warehouses at the heart of it all.
Pharmaceutical warehousing is the process of successfully storing medications using advanced equipment and technologies. This practice is a part of pharmaceutical cold chain management, the end-to-end operation of controlling temperatures and environmental conditions while also addressing factors such as sanitization practices and handling techniques. These procedures aim to construct an organized facility that promotes the safe treatment of delicate products.
The Importance of Temperature Control in Pharmaceutical Warehousing
Temperature control is essential to any pharmaceutical warehouse to ensure these products are safe and in top-quality condition upon arrival to the end user. These individuals rely on their prescription drugs and medications to improve their quality of life by relieving symptoms and curing diseases. This importance to human life is reason enough to establish a solid temperature control workflow in your warehouse. However, it also provides additional benefits, such as:
- Quality: Temperature control is a key factor in preserving the chemical integrity of pharmaceuticals. Any deviation in storage climate could cause degradation, reduce potency or lead to unwanted effects in patients.
- Compliance: Various regulatory bodies, like the Food and Drug Administration (FDA), set strict guidelines for proper storage practices. Temperature control is often at the center of these guidelines, and failure to follow them results in penalties and possible license revocation.
- Cost: Implementing the proper temperature-regulating equipment will minimize the risk of damaged products and lost inventory. Consistent and accurate temperatures create a safe environment to keep your operations profitable and your customers satisfied.
Types of Temperature-Sensitive Pharmaceuticals
Pharmaceuticals are unique in their chemical makeup, giving them distinct temperature sensitivities. Most products have strict conditions at which they must be stored to ensure their integrity. Even the slightest variations in temperature or humidity can lead to changes in the product’s chemical stability, which can potentially cause harmful side effects or loss of effectiveness.
Manufacturers, suppliers and distributors must store most pharmaceutical products within temperatures ranging from 2 to 8 degrees Celsius or 35 to 46 degrees Fahrenheit, per the Centers for Disease Control (CDC). This range includes many biologics, vaccines and other medicines, such as insulin.
Some require slightly higher temperatures, around 59 degrees Fahrenheit to 77 degrees Fahrenheit, called ambient medicines, which are drugs and medications formed as tablets, capsules or powders. Finally, “Ultra-cold” temperatures below -176 degrees Fahrenheit are generally required for specialty vaccines, biologics, blood products and tissue samples.
Regulations and Standards for Temperature-Sensitive Pharmaceuticals
Patients cannot truly know if the prescribed medications are safe to use unless manufacturers, distributors and other pharmaceutical organizations adhere to strict safety and temperature control practices. The FDA is one of the organizations responsible for ensuring quality by creating a systematic set of rules under their Current Good Manufacturing Practice (CGMP) regulations. These temperature-sensitive pharmaceutical regulations are developed to reduce the likelihood of contamination, mix-ups, failures and deviations.
CGMP enforces the suitable design and control of manufacturing processes, as well as the proper facility monitoring practices required to ensure pharmaceuticals are of the highest quality. These guidelines require testing and address essential factors such as properly maintained and calibrated machinery and operator training. Drugs that are not manufactured, processed, packed or held according to these standards are known as being “adulterated” and deemed not to be safe for use.
Other temperature control regulations include:
- International Council for Harmonization (ICH) Quality Risk Management Q9: Under the ICH Q9 guidelines, all manufacturers and suppliers must ensure their storage and transport equipment are well-maintained to create suitable conditions. Factors determining suitable conditions include the container’s design and its ability to maintain specified temperatures, humidity levels and capacity.
- Temperature Control Regulations (TCR): The International Air Transport Association (IATA) routinely publishes its comprehensive TCR guide outlining the key elements necessary to your cold storage facilities and shipping practices. Aligning with these requirements facilitates the ideal storage, labeling, marking and tracking of temperature-sensitive vaccines and other pharmaceutical products.
Methods and Technologies for Maintaining Temperature Control
The cold chain management workflow encapsulates the end-to-end process of storing and transporting temperature-sensitive products, such as vaccines, medications, biologics and more. Maintaining an effective environment to accomplish these goals requires specific climate control and monitoring equipment to avoid contamination, degradation and loss of potency. These tools will allow you to create the ambient, refrigerated, frozen and ultra-frozen conditions that many products require.
You’ll have to consider multiple parts of the cold chain to acquire the right temperature control technology and machinery to support your workflow. Logistics solutions providers, like Crown LSP Group, offer services to simplify the cold chain process. They’ll help you address components such as:
Storage
Pharmaceuticals, such as prescription medications, drugs, biologics and others, respond differently to various types of conditions. There are three types of temperature-controlled facilities equipped with a variety of cold rooms, freezers and refrigerators to create the perfect environment. Which one you require will depend on the products you’re storing, falling within one of the following facility categories:
- Frozen: Facilities are chilled to temperatures below 32 degrees Fahrenheit.
- Refrigerated: Facilities are maintained between 34 and 40 degrees Fahrenheit.
- Conditioned: Facilities are cooled to temperatures between 68 and 70 degrees Fahrenheit.
Packaging
Products must be adequately packaged before being placed on transport vehicles to ensure they arrive at their destination in top condition. The right packaging will provide the necessary insulation while also offering adequate protection against any potential threats they may encounter during transit. Finalized packaging should also present the necessary temperature information and special delivery instructions.
Materials that can be used to package pharmaceuticals include:
- Cold packs
- Phase change materials
- Foam coolers
- Insulated boxes
- Thermal bubble wrap
Transportation
Once packed in the proper containers and correctly marked per regulations, pharmaceuticals are placed within transport-specific equipment. Refrigerated trucks are often the most popular form of transportation, equipped with a high-powered refrigeration system, insulation and a heat-tight seal to reach the low temperatures required to maintain the integrity of pharmaceuticals. Operators should perform cargo inspections at regular intervals to ensure products remain in the proper temperature range.
Monitoring
Whether in storage or on the road, utilizing high-quality temperature monitoring technologies is imperative. These technologies provide professionals with an accurate, real-time look at products moving throughout the supply chain.
Control systems look at various factors such as temperature, humidity, carbon dioxide and differential pressure to alert your team to deviations in optimal conditions. Alert notifications can be customized to meet your product’s unique specifications and temperature ranges, giving you the time necessary to react before the effects become permanent.
Monitoring practices during storage are known as static monitoring, while surveillance during transport is referred to as dynamic monitoring. Some of these technologies that make this possible include:
- Data loggers
- Wireless temperature sensors
- Digital temperature logs
- Real-time temperature monitors
Store Your Temperature Sensitive Pharmaceuticals With Crown LSP Group
At Crown LSP Group, we pride ourselves on supporting the workflow of pharmaceutical manufacturers and suppliers with premium distribution and logistics services. We’re a family-owned business that’s been in business since 1987, dedicated to our mission of serving our local community in Rocky Mount, North Carolina and delivering top-of-the-line customer experiences.
These years in business have given our experts the in-depth knowledge and experience to develop personalized strategies that address your pharmaceutical supply chain demands. Count on Crown LSP Group to supply temperature-controlled pharmaceutical warehousing solutions you can trust.
Our facilities are strategically equipped with high-performance temperature regulating units to ensure we meet the needs of your products. We have the ability to tailor these spaces to fit your inventory configuration and take the weight off your shoulders while saving you time and money. You’ll only ever pay for the services and warehouse space you use, ensuring you can make the most of your resources.
Contact Our Team to Learn More
Count on Crown LSP Group to care for your pharmaceutical products with the care and attention to detail you deserve. Interested in learning more about our temperature-sensitive warehousing solutions? Request a quote or contact us online to connect with our professionals and discover all the ways our team can benefit your pharmaceutical business.
