May 12, 2020

cold storage

Controlled room temperature (CRT) storage is at the core of perishable supply chains. The ability to store goods in temperature-controlled environments enables businesses to better manage their supply chains, increase the shelf life of products and keep and maintain an inventory that is vital to their business. However, CRT storage is not as straightforward as standard warehouse management; it requires precision, extensive knowledge of the products being stored and the regulations that govern them, and a proper facility that many businesses aren’t equipped with. 

Whether you deal in medical devices, pharmaceuticals, refrigerated/frozen foods, or any other perishable goods, there are several things you should know about storing temperature-sensitive goods. 

Federal codes and guidelines
Depending on the types of products being stored, there are different guidelines that must be followed. These guidelines include storage facility requirements, storage temperatures and regulations for how products can be packaged and handled. 

The Food and Drug Administration (FDA), has laid out extensive guidelines in their Code of Federal Regulations (CFR), which regulate multiple categories of products, including “General Drugs; Drugs for Human Use; Animal, Drugs, Feeds, and Related Products; Biologics; and Medical Devices. 

Helpful tip: the CFR states that “storage and transportation of finished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container.” 

The rules and regulations for storing “Food for Human Consumption” are outlined in CFR 21, Part 111: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. 

View the entire CFR guidelines on food for human consumption here. 

The rules and regulations for storing “General Drugs” are outlined in CFR 21, Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals. 

View the entire CFR guidelines on general drugs here. 

The guidelines within these regulations include: 

  • Personnel qualifications 
  • Physical plant and ground requirements 
  • Necessary equipment and utensils 
  • Requirements for process control systems 
  • Requirements for quality control 
  • Requirements for components, packaging and labels 

All other FDA regulations when it comes to storing temperature-sensitive products — including a deep dive into specific perishable products — can be found in the FDA’s searchable database for CFR 21. Understanding the regulations that govern these products is the most crucial component of CRT storage. Not only will it give you the basis of the best practices for your products, it will also keep you in line with FDA regulations, a requirement for all businesses that handle perishable products. 

Storage capabilities and processes
Understanding the lay of the land when it comes to federal regulations that govern the storage of temperature-controlled goods is only half the battle. Once businesses are armed with the requisite knowledge, they must overcome the challenge of setting up the space and equipment necessary to safely store their products. There are several components to setting up a facility capable of CRT storage: 

  1. Isolated space: temperature-sensitive products need to be isolated based on their storage temperature. Other isolation guidelines include separating products that are hazardous and those that contain the potential for cross contamination. Facilities need to be outfitted with isolated storage containers or specified areas that keep products properly isolated and maintained. 
  1. Storage systems: temperature and humidity regulation systems must be able to meet storage requirements 100% of the time. Forced air cooling is generally the most efficient way to maintain temperatures in a facility. These systems must also be backed by certain failsafe measures. These measures include systems that monitor temperature and humidity levels (complete with alerts that notify employees of fluctuations) and those that provide backup power in the event of a power outage. 
  1. Management systems: inventory and warehouse management systems help facilities keep track of stock levels, orders, expiration dates on products and other important information. 
  1. Best practices: personnel are just as important as buildings and coolers. Employees must be trained in proper rotating, handling and packaging of products. Employees must also be trained in the proper use of equipment, maintenance and repair of systems and equipment, the reading and monitoring of temperature logs, and proper sanitation of facilities and equipment. Finally, certification in AIB (for food safety auditing and education) is also helpful. 
  1. Cost controls: temperature-controlled storage can increase a facility’s operational costs, but these can be mitigated to an extent by investing in proper ventilation and insulation systems, which can cut down on utility costs. 

Outsourcing and partnering
Not all businesses are equipped to handle CRT storage. Some simply find the process too time-consuming, expensive and risky when it comes to federal regulations. That’s why many businesses choose to outsource the storage, shipping and fulfillment of their temperature-sensitive products to a trusted third-party logistics provider. 

At King Solutions, we offer a comprehensive range of customizable solutions for the storage of pharmaceuticals, raw materials, medical devices and other temperature-controlled products.   

Our solutions include: 

  • Temperature-controlled transportation, order integration and IT support  
  • GPS tracking at the pallet level  
  • Strict adherence to the most stringent FDA regulations  
  • 101,000 sq. ft. of secure temperature-controlled warehousing space  
  • Motion-sensor lighting and 24/7 video surveillance 

King is Current Good Manufacturing (cGMP) and Normal Room Temperature compliant. We have two warehousing and fulfillment facilities in the greater Minneapolis and Chicagoland areas. If you are looking for CRT storage, contact one of our logistics specialists today.


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