Temperature Sensitive Shipping Glossary
Glossary of Terms: Temperature-Controlled and Time-Sensitive Transportation for Pharmaceutical and Biotech Industries
Active Cooling:
Technology-driven systems, such as powered containers, that actively regulate and maintain the internal temperature of a shipment through electrical or battery power.
Active Pharmaceutical Ingredients (APIs):
The biologically active components in pharmaceutical drugs that may require temperature-controlled transportation to maintain their stability and potency.
Air Cargo Services:
Specialized transportation services that handle the shipment of goods via air, including temperature-sensitive pharmaceuticals that require compliance with IATA regulations.
Ambient Temperature Control (15°C – 25°C):
Packaging and transportation solutions designed to maintain a stable room temperature environment, often required for products that do not need refrigeration but must avoid temperature extremes.
Cold Chain:
A temperature-controlled supply chain that ensures pharmaceutical and biotech products are kept within required temperature ranges from production to delivery.
Cold Storage:
Facilities designed to store pharmaceutical products at controlled low temperatures before, during, and after transportation.
Compliance Audits:
Regular reviews conducted to ensure that all aspects of the transportation process, including packaging, handling, and storage, comply with industry regulations and standards.
Controlled Room Temperature:
A specific temperature range defined by industry standards, typically 15°C to 25°C, used for the storage and transportation of pharmaceuticals that do not require refrigeration.
Cool Chain:
A subset of the cold chain focused specifically on maintaining controlled temperature conditions for the transportation of refrigerated products (typically 2°C to 8°C).
Cryoshipper:
A specialized container used for the transportation of cryogenic materials, such as cells and tissues, at ultra-low temperatures, often involving liquid nitrogen.
Dangerous Goods Regulations (DGR):
Regulations governing the safe transport of hazardous materials, including dry ice and liquid nitrogen, which are often used in temperature-controlled shipping.
Dry Ice (-78.5°C):
Solid carbon dioxide used as a cooling agent for transporting products that require extremely low temperatures, typically for frozen or ultra-low temperature shipments.
Frozen (-20°C to -15°C):
A temperature range used for products that must be kept frozen, such as certain vaccines or biological samples.
Gel Packs:
Refrigerant packs filled with a gel that can maintain cold temperatures for short durations, often used in combination with insulated packaging.
Good Distribution Practice (GDP):
Guidelines ensuring that pharmaceutical products are consistently stored, transported, and handled under suitable conditions as required by their marketing authorizations.
Hybrid Systems:
Packaging solutions that combine active cooling with phase change materials to maintain temperature, especially when external power sources are unavailable.
Insulated Shippers:
Containers that provide thermal insulation to protect temperature-sensitive products during transportation, often used in combination with refrigerants like gel packs or PCM.
Inventory Management:
The process of overseeing the storage, handling, and distribution of pharmaceutical products, including the management of temperature-controlled packaging materials to ensure availability and readiness for shipment.
Last Mile Delivery:
The final step in the transportation process, where the product is delivered to its final destination, often requiring continued temperature control until it reaches the end-user.
Liquid Nitrogen (-195.8°C):
A cryogenic liquid used to maintain extremely low temperatures for the transport of sensitive biological materials like cells, tissues, or certain pharmaceuticals.
Packaging Configuration:
The specific arrangement and preparation of materials within a shipping container to ensure optimal temperature control and protection of the contents.
Passive Cooling:
Non-powered packaging solutions that rely on insulation and refrigerants like gel packs or PCM to maintain the required temperature without active temperature regulation.
Phase Change Material (PCM):
Substances used in packaging that absorb or release heat at specific temperatures, helping to maintain a stable temperature for extended periods.
Preconditioning:
The process of preparing temperature-controlled packaging by bringing it to the required temperature before it is used for shipping, ensuring it is ready to maintain the desired conditions throughout the journey.
Quality Assurance (QA):
The process of ensuring that all aspects of the pharmaceutical supply chain, including temperature-controlled transportation, meet predefined quality standards and regulatory requirements.
Real-Time Monitoring:
The use of sensors and tracking devices to monitor the temperature and location of a shipment in real time, ensuring that conditions remain within the required range throughout transit.
Refrigerated (2°C – 8°C):
Temperature range required for many biological products and pharmaceuticals to maintain their stability and efficacy during transportation.
Risk Management:
The practice of identifying, assessing, and mitigating risks associated with the transportation of temperature-sensitive pharmaceuticals, including the potential for temperature excursions.
Shelf Life:
The length of time a pharmaceutical product remains effective and safe to use, which can be affected by temperature exposure during transportation.
Stability Profile:
The documented behavior of a pharmaceutical product under various environmental conditions, including temperature, which helps determine the required storage and transport conditions.
Temperature-Controlled Packaging:
Specialized packaging designed to maintain a specific temperature range during the transportation of temperature-sensitive products.
Temperature Excursion:
Any instance where the temperature of a pharmaceutical product goes outside its specified range, potentially compromising the product’s quality and efficacy.
Temperature Logger:
A device placed within a shipment to continuously record the temperature during transportation, allowing for post-transport analysis to ensure temperature compliance.
Temperature Mapping:
A process of studying and recording temperature variations within a specific area, such as a storage facility or shipping container, to ensure consistent temperature control.
Thermal Insulation Chamber (TIC):
An insulated container that helps maintain the temperature of its contents by minimizing heat exchange with the external environment.
Thermo-regulated Pallet Shippers:
Large, insulated containers designed for pallet-sized shipments that require temperature control, typically used for bulk pharmaceutical products.
Time and Temperature Sensitive Label (IATA):
A label used to identify shipments that require specific temperature controls during transportation, as per International Air Transport Association (IATA) regulations.
Unit Load Device (ULD):
A standardized container or pallet used to load cargo onto an aircraft, which may include temperature-controlled units for pharmaceuticals.
Validation:
The process of testing and verifying that packaging and transportation methods will maintain the required temperature conditions throughout the shipment’s duration.