A New Wave Of Regulations: Monitoring Room Temperature

Posted on: January 25th, 2015 by Dickson No Comments

Monitoring Room Temperature

Pharmaceuticals are some of the most closely monitored goods in the world, and their storage conditions are no exception. Until recently however, when a company was monitoring the temperature of a pharmaceutical drug, they were probably only interested in those drugs that inhabited the cold chain. What we mean by that, is manufacturers and distributors of drugs and medicine were primarily concerned with the products that needed to be refrigerated or frozen at all times. Temperature data loggers and chart recorders could (and still can be) found in their coolers, freezers, and refrigerated trucks.

What was not commonplace back in the day, was monitoring at room temperature. Why? Well, because it’s room temperature. When you take an Aspirin or Cough Syrup, you’re not really worried about how it was stored, right? If it doesn’t say ”refrigerate after opening,” or ”keep refrigerated,” there is nothing to worry about, right?

Sorry, wrong. Controlled Room Temperature, or CRT, has become a bigger and bigger focus of pharmaceutical distributors and manufacturers, because private auditing agencies and governmental regulations care more about it, and products have been lost due to mismanaged room temperature monitoring.

What is room temperature, by the way? What is its definition? What temperature, is room temperature? Some may say 70F, or 75F, or 65F, or something completely different. There is a range, but before recent regulations in the last decade from agencies like the FDA and USP, that range was just assumed. It’s not anymore, and it really shouldn’t be.

A CRT Definition

It’s easiest to understand CRT if we pit it against the Cold Chain. It’s widely accepted that the Cold Chain inhabits a temperature range of 35-46F for refrigerated goods, and -35-5F for frozen goods. Items that say keep refrigerated or keep frozen, for the most part, fit into those ranges.

CRT however, inhabits anything above that 46F threshold. Most times, this is between 60-80F, but not always. This differentiates in theory, the practice of monitoring the temperature of products that can be stored at ”room temperature”: it comes down to the product label.

Thus, gone are the days of shipping CRT goods with standard packaging, and with an absence of temperature monitoring, and in are the days of label reading, and sorting a warehouse to account for products that are CRT goods.

The Challenge

The biggest challenge facing CRT storage however, is not in temperature monitoring or sorting. Buying a few more data loggers, or rearranging a warehouse is a very solvable problem, a small hurdle. The largest hurdle comes from refrigerants in tight, compact spaces, and the choice companies have between active and passive systems.


 

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