Some pharmaceutical products require specific temperature conditions to maintain their efficacy and safety. To maintain temperature ranges during transit, pharmaceutical companies utilize cold-chain packaging solutions that include coolers and refrigerants. We will review how cold chain packaging solutions create unique challenges for warehouse design and operations that one must mitigate.
Cooler and Refrigerant Storage
Temperature-controlled storage must be designed to store not only the finished goods material, but the coolers and refrigerants as well. Adding complexity, the storage temperature range for each component of the cold chain packaging can vary. Throughout the design process and ongoing yearly operations planning, there is tension between the fact that the operation cannot run out of cold chain packaging supplies to ship orders and the cost of oversizing the temperature-controlled storage spaces.
Adding another layer of complexity, some cold chain packaging solutions require that the refrigerants are conditioned in storage before they can be used for shipments. In addition to throughput, the duration of the conditioning is an essential input to sizing the space and ongoing capacity considerations of temperature-controlled spaces. A process must be developed to track the conditioning duration physically or systematically.
Some cold chain packaging solutions require pre-conditioned coolers. It is not uncommon for operations to have both unconditioned solutions and pre-conditioned solutions. Pre-conditioned solutions include coolers with refrigerants at the appropriate temperature already packed in the cooler for shipment. Pre-conditioned coolers may have an expiration date a few days after receipt. As a result, there is tension when designing or operating with pre-conditioned coolers. The operation cannot run out of coolers; however, the operation cannot be so conservative with their cooler storage such that an excessive quantity of coolers will will be sent back to the supplier for re-conditioning.
Addressing Safety Challenges
Cold chain packaging solutions present safety challenges since the picking and packing may occur in a cooler or freezer, the refrigerant may present hazards, or the coolers may exceed safe lifting weights, especially when repetitive motion is considered.
To address the cooler or freezer picking environment, the operators must wear appropriate personal protective equipment (PPE) while picking and packing, which makes the operator less efficient. The slower pick and pack productivity rate must be considered when designing the process and any automated material handling equipment.
The cooler weight requires material handling solutions to move the coolers from pallets to the conveyor at the beginning of the process and from the conveyor to pallets at the end of the process. Several common methodologies are used to improve the ergonomics of the lift. Lift Tables or Electric Walkie Stackers are used to lift the pallet to the same height as the conveyor to reduce the heavy lift. To augment the previous solution, vacuum lifts can be used by a single operator to grip, support, lift and lower the load. However, neither of the previous solutions resolves the 90-degree swivel from the pallet to the conveyor or from the conveyor to the pallet. As a result, robots will play a larger role in lifting heavy coolers once the price becomes more amendable.
Some operations utilize dry ice to maintain temperature ranges during transit. As dry ice melts, it turns into carbon dioxide gas. If this space is too small and/or not well ventilated, the carbon dioxide gas is an Asphyxiation Hazard potentially causing dizziness, headaches, difficulty breathing, loss of consciousness and death. As a result, the space should be appropriately sized and ventilated to mitigate the issue. Dry ice is also a Contact Hazard meaning skin contact with dry ice can lead to severe frostbite. The contact hazard can be mitigated through the use of appropriate personal protective equipment (PPE).
Quality Process Requirements
The Drug Supply Chain Security Act (DSCSA) requires a system to identify and trace certain prescription drugs as they are distributed to improve safety. Operationally, this requires scanning the serial number on each item or inner pack or case. One must determine whether this serial scan occurs during picking, pre-packing, or packing. The decision has ramifications on the equipment required, throughput, and systems.
To verify that the desired temperature range is maintained, temperature monitoring is required. During the packing process, the operator must insert and activate the temperature monitoring device, which impacts the pack station design and systems.
Conclusion
Cold chain shipments are essential in the pharmaceutical supply chain to maintain the efficacy and safety of pharmaceutical products during transit. While cold chain packaging presents many challenges in the design and operations of a warehouse, these challenges can be overcome or mitigated through proper planning and operations.
—Scott Gaston, St. Onge Company
