Best Practice for a Refrigerator Temperature Log in a Pharmaceutical Environment

Pharmaceutical facilities are required to store vaccines and prescription drugs at specific temperatures to guarantee patient safety and ensure optimal shelf life and efficacy.

The temperatures of the pharmacy refrigerators in which these medications are kept must be monitored regularly to ensure that they comply with the manufacturer's storage guidelines.

Compliance with climate control regulations is also a crucial part of pharmacy audits, so precise temperature logging and record keeping play an essential role in every facility that stores prescription medication.

Traditionally, temperatures were logged by hand on paper, but this is no longer regarded as the best practice. Technology, in the shape of electronic temperature logging systems, now offers more efficient options for maintaining an accurate temperature log.

Considering the various ways of monitoring fridge temperatures and any risks associated with each system allows one to determine the best option for a pharmaceutical facility.

Handwritten Minimum/Maximum Records

To keep a handwritten refrigeration temp log, the staff must check the fridge temperatures manually, once or twice a day, depending on the relevant standard operating procedure (SOP).

The procedure requires a staff member to walk around and visually check the refrigerator temperature before writing the data on a log sheet or in a notebook. It can be quite a challenge in a busy facility to schedule time to complete the task, especially when a minimum period must elapse between the two checks. Such a system poses several risks to data integrity:

1. Human Error

One might simply forget to check the temperature or record the data incorrectly.

2. The Refrigeration Temp Log Only Covers Working Hours

A further problem might arise if the SOP requires that the fridge temperatures are checked twice, at the start and the end of the working day. The risk here is that the temperatures might be satisfactory in the evening but incorrect by the morning.

In the event of a temperature excursion, there is no way of knowing when the problem occurred or how long the refrigerator has been in alarm.

Naturally, most pharmaceutical facilities have a policy of assuming the worst and therefore discard the products stored in that refrigerator. Such an event can negatively affect a pharmacy's reputation, and result in significant financial loss.

Even more serious is the risk of medications or vaccines no longer being effective because they have deteriorated when not stored at the correct temperature.

3. Errors in Data Storage

When refrigeration temperature records are written by hand and transferred to storage manually, or even if it is manually transferred to a LIMS data management system, there is always a risk of data being altered or omitted.

Digital data loggers not only collect refrigerator temperature data, but they also usually come with an integral storage device. The information is time-stamped, a practical solution to complying with regulations for medicines. Such systems interface with a computer, allowing one to retrieve information and generate reports.

The advantage of a digital data logging system is that the information is gathered and stored in a digital format that complies with standard FDA 21 CFR Part 11. However, the data loggers still need to be collected manually and then connected to a computer before the data can be uploaded, a time-consuming process in a busy lab.

The latest developments in this field are stand-alone independent monitoring systems for equipment and rooms. A stand-alone base indicates refrigerator temperature, battery life, and warnings, and will sound an alarm in the event of a battery failure or temperature excursion.

Networked Data Loggers

A central monitoring system (CMS) consists of several data loggers connected to a central system on a network or computer. The data loggers collect refrigerator temperatures and other information automatically, archiving the data and storing it securely according to data integrity regulations.

If a temperature excursion occurs, a remote alarm notification is sent so that staff can take immediate action. A networked data logging system saves technicians from recording and log fridge temperatures manually and can add up to a considerable cost saving.

The most sophisticated networked data log systems such as ELPRO's Bluetooth®-enabled LIBERO data loggers are suitable for a wide range of cold chain and laboratory monitoring applications.

They offer tools that allow times and dates of temperature points to be analyzed, and data queried, a significant advantage when carrying out audits.

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Implementing the Best Refrigerator Temp Log Practice

In the past, keeping paper temperature monitoring records was considered acceptable, as there were no alternatives. But today's fully-integrated refrigeration temperature monitoring systems are not only cost-effective and straightforward to install, but also allow continuous, automated monitoring 24/7.

Following the best practice for a refrigerator temp log by installing an electronic monitoring solution gives pharmacists more time to spend with customers, provides peace of mind that the vaccines or prescriptions drugs they are dispensing are safe, and ensures data compliance.

The key advantages of a network refrigeration temperature monitoring system at a glance:

• 24/7 continuous monitoring helps ensure that vaccines and other pharmaceuticals are always stored at the correct temperature.

• You receive an automatic alert via email or SMS if there is a temperature excursion.

• Affordable, quick and straightforward to install

• Simple to use.