Flawless logistic management is key to protect cold chain products
Logistic management is a crucial task to maintain the quality of deliverables during transportation. Continuous engagement of specialized logistic department works hard to maintain the controlled temperature during the storage, preservation, and transportation of shipping the atmospheric temperature-sensitive products. Maintaining a certain temperature is essential to uphold the quality of such products including many pharmaceutical products. Inconsistent temperature can cause spoilage of many pharmaceutical products, which leads to serious consequences on the health and wellbeing. Cold chain logistic management is an imperative part of pharmaceutical product delivery to prevent any adverse event.
The temperature difference can affect the chemical stability of the medicine and may alter physical properties also. For example, emulsion or suspension dosage forms can separate out and form sediment. Currently, stringent regulatory regulations demand proper documentation for maintaining temperature to prove that products are transported through a temperature-controlled supply chain.
There is a certain borderline of the temperature difference that is acceptable depending upon the nature of the product. But regulatory requirements have stringent regulation for cold chain pharmaceutical products like vaccines, insulin, and other such products. The temperature integrity for cold chain products requires to maintain between 20C to 80C. This temperature range is known as the ‘cold chain’ temperature range. Therefore, products that are considered cold chain products should be stored and maintained the same temperature range during transportation. Therefore, all the stakeholders including manufacturer, transporter, and wholesaler are responsible to maintain this temperature of the cold chain products to preserve efficacy and safety. However, the manufacturer of the product is primarily responsible for ensuring the maintenance of the optimum condition of the products during shipment. Therefore, the manufacturer department needs continuous discussion with the logistic department for taking the information about cold chain capacity and address the gap to present on current and future requirements. The logistics department needs to give details about the process of resource mobilization to the manufacturer and ensures the implementation of effective monitoring. A continuous up-gradation of the cold chain is required to maintain by implementing the latest technology including selection, installation of new equipment, utilization of tools, and techniques for a better understanding of the advanced equipment. The logistics department must use temperature monitoring and control device for cold chain supply. The logistics department also needs to hire a competent technician and take necessary action to retain the existing expertise staff for continuous workflow. Another important criterion to sustain cold chain workability requires assurance of the availability of spare parts.
The following are some essentials points require to consider before temperature-controlled solutions.
- The suitable range of temperature and humidity.
- The maximum tolerable range of temperature.
- The standard level of risk acceptability.
- The probable associated risk factors
- The sensitivity markers
- The essential actions required to maintain the quality of product integrity.
The following are some additional conditions which are specifically required to consider for cold storage:
- The temperature range depends upon the volume of the medicine
- How to control the temperature within a specific range
- Alternative measures to control the temperature within the limit
- The proper planning of the storage unit and layout for airflow.
- Outer temperature logging and data tracking
- Placement of shipment (avoid areas where temperature variation is likely such as near bay doors)
- Verification of the temperature range.
- The volume of medical products.
Refrigerated vehicles, passive shipping containers and active shipping systems are different types of temperature-controlled logistics often used by the pharmaceutical industry.
Logistic management is a crucial task to maintain the quality of deliverables during transportation. Continuous engagement of specialized logistic department works hard to maintain the controlled temperature during the storage, preservation, and transportation of shipping the atmospheric temperature-sensitive products. Maintaining a certain temperature is essential to uphold the quality of such products including many pharmaceutical products. Inconsistent temperature can cause spoilage of many pharmaceutical products, which leads to serious consequences on the health and wellbeing. Cold chain logistic management is an imperative part of pharmaceutical product delivery to prevent any adverse event.
The temperature difference can affect the chemical stability of the medicine and may alter physical properties also. For example, emulsion or suspension dosage forms can separate out and form sediment. Currently, stringent regulatory regulations demand proper documentation for maintaining temperature to prove that products are transported through a temperature-controlled supply chain.
There is a certain borderline of the temperature difference that is acceptable depending upon the nature of the product. But regulatory requirements have stringent regulation for cold chain pharmaceutical products like vaccines, insulin, and other such products. The temperature integrity for cold chain products requires to maintain between 20C to 80C. This temperature range is known as the ‘cold chain’ temperature range. Therefore, products that are considered cold chain products should be stored and maintained the same temperature range during transportation. Therefore, all the stakeholders including manufacturer, transporter, and wholesaler are responsible to maintain this temperature of the cold chain products to preserve efficacy and safety. However, the manufacturer of the product is primarily responsible for ensuring the maintenance of the optimum condition of the products during shipment. Therefore, the manufacturer department needs continuous discussion with the logistic department for taking the information about cold chain capacity and address the gap to present on current and future requirements. The logistics department needs to give details about the process of resource mobilization to the manufacturer and ensures the implementation of effective monitoring. A continuous up-gradation of the cold chain is required to maintain by implementing the latest technology including selection, installation of new equipment, utilization of tools, and techniques for a better understanding of the advanced equipment. The logistics department must use temperature monitoring and control device for cold chain supply. The logistics department also needs to hire a competent technician and take necessary action to retain the existing expertise staff for continuous workflow. Another important criterion to sustain cold chain workability requires assurance of the availability of spare parts.
The following are some essentials points require to consider before temperature-controlled solutions.
- The suitable range of temperature and humidity.
- The maximum tolerable range of temperature.
- The standard level of risk acceptability.
- The probable associated risk factors
- The sensitivity markers
- The essential actions required to maintain the quality of product integrity.
The following are some additional conditions which are specifically required to consider for cold storage:
- The temperature range depends upon the volume of the medicine
- How to control the temperature within a specific range
- Alternative measures to control the temperature within the limit
- The proper planning of the storage unit and layout for airflow.
- Outer temperature logging and data tracking
- Placement of shipment (avoid areas where temperature variation is likely such as near bay doors)
- Verification of the temperature range.
- The volume of medical products.
Refrigerated vehicles, passive shipping containers and active shipping systems are different types of temperature-controlled logistics often used by the pharmaceutical industry.