Cold chain management is a crucial aspect of the pharma industry, as it involves the preservation of temperature-sensitive drugs and medical products from the time of manufacture to the point of administration.
In today’s article, we will explore the challenges and best practices involved in pharmaceutical cold chain management. Furthermore, we’ll aim to understand how it impacts the quality and availability of essential medicines. And lastly, delve into the importance of temperature monitoring, the role of transportation and packaging, and the use of technology in ensuring the reliability of the cold chain.
What is a pharmaceutical cold chain?
A cold chain is an integral part of pharma shipments and transits. It is a temperature-controlled supply system used to transport and store perishable products, such as vaccines, biologics, and drugs.
This chain must maintain a specific temperature range, often between 2°C and 8°C, to preserve these products’ potency, efficacy, and safety. It starts at the point of manufacture and continues through to the point of distribution, with temperature monitoring and control at each stage.
Any deviation from the required temperature range can cause significant harm to patients, making the cold chain a critical component of the pharmaceutical industry.
How does a pharmaceutical cold chain work?
The process employs specialised machinery and equipment to create and maintain low temperatures during transportation and storage, from production to the patient. In practice, low temperatures are continually monitored and tracked at regular intervals to ensure the cold chain remains unbroken.
Importance of cold chain in the pharmaceutical industry
Products, such as vaccines and biologics, are often life-saving and must be maintained within a specific temperature range to remain effective.
If the temperature of these products deviates from the desired range, it can cause significant harm to patients, or reduce the effectiveness of the treatment, leading to serious health complications.
It is also important to comply with regulatory requirements and industry standards. These are put in place to protect the users of pharmaceutical products.
Key components of a pharmaceutical cold chain
A pharmaceutical cold chain is a complex system that involves several components, each plays an important role in ensuring the integrity of temperature-sensitive medicines and chemicals.
- Packaging: Temperature-sensitive pharmaceutical products are packaged in special materials that provide insulation and maintain the desired temperature range. This packaging must be designed to meet each product’s specific requirements and protect it during transit and storage.
- Storage: Temperature-controlled facilities are used to store perishable and sensitive pharmaceutical products. They are equipped with machinery to create and maintain low temperatures and also monitoring system with real time tracking.
- Transportation: Refrigerated containers, such as DNV certified offshore reefer containers are used to transport temperature-sensitive pharmaceutical products to marine O&G rigs. They are also equipped with automated temperature and ventialtion control systems to maintain the desired ranges during transit.
- Temperature monitoring: Temperature monitoring devices, such as data loggers and wireless temperature sensors, are used to track the safety of the products during storage and transportation. This data is used to detect temperature excursions and to take corrective actions when necessary.
- Compliance and training: Compliance with regulations and standards is critical to ensuring the integrity of the cold chain. Compliance-related activities involve regular training of personnel and implementation of standard operating procedures to ensure that the cold chain operates efficiently.
- Technology: Technology plays an important role in the pharmaceutical cold chain, especially when controlling and monitoring temperature, or even tracking the location of products during shipping. This helps to ensure real-time visibility and control of the cold chain and to improve decision-making.
Each of these components must work together to ensure the integrity of pharma products. By maintaining a well-designed cold chain, the industry players can ensure that life-saving treatments are available and are effective for all types of patients at distant locations like offshore platforms.
Cold chain management in pharmacy- best practices
1. Choose the right reefer containers for shipping
Reefer containers are refrigerated containers used to transport and store temperature-sensitive pharmaceuticals. Reefers can be the difference between effective and ineffective drugs or, indeed, safe and unsafe medicines.
MGS Offshore provide automated refrigerated containers that can maintain temperature ranges as low as -60 degrees Celsius (-76 degrees Fahrenheit). These are extremely important for temperature-sensitive pharmaceutical products.
2. Choose temperature-controlled packaging
It is important that temperature-sensitive pharmaceutical products are packaged in materials that provide insulation and keep the products within the desired temperature range. This packaging should be designed to meet the specific requirements of each product and to protect it during transit and storage.
3. Real-time tracking during transit
Real-time tracking of temperature-sensitive products during transit is an important aspect of cold chain management in pharmacies. This involves temperature monitoring, GPS tracking, the use of real-time alerts and notifications.
4. Have a backup plan for unexpected events
Having a backup plan is a very important aspect of cold chain management in pharmacies. For example, backup equipment like extra generators may help to ensure that temperature-sensitive products are stored and transported safely, especially in event of power outages.
5. Having standard operating procedures (SOPs)
SOPs for running a pharmaceutical cold chain are of great importance. They provide clear, detailed and standardised instructions on how to maintain the the safety of the products.
Effective cold chain management can be a matter of life and death for end consumers. This is because just a single-degree rise in the temperature of biologics, compounded infusions, and specialty drugs can seriously harm a drug’s potency.
Fortunately, the biopharma industry maintains a standardised range of measures to ensure the temperature control of temperature-sensitive pharma products, as discussed above.
Check out the range of DNV certified offshore reefer containers available at MGS Icestorm for shipping your valuable pharma products to offshore locations.
A graduate (Business) from KDU, Jason Tan, is the current Business Director (Sales) for MGS Icestorm and has been associated with the company for the past 10 years.
With over 13 years in the shipping industry, he has had a significant contribution to Malaysia’s oil and gas industry in the engine and boat supply sector.
His expertise includes managing offshore catering business, offshore reefer containers, AI technology, offshore gas tanks, A60 pressurized cabins, etc. His contributions have helped establish MGS, in partnership (joint venture) with Thermo King and Honeywell to produce state of art Offshore Reefer Container products.