USP Controlled Room Temperature Documentation and Compliance Strategy

USP Controlled Room Temperature Documentation and Compliance Strategy
Posted in: Healthcare Pharmacy

The United States Pharmacopeia guidelines call for specific temperature conditions that ensure the integrity and efficacy of medications and vaccines. Both adhering to USP controlled room temperature requirements and documenting any fluctuations is crucial to compliance, and you can learn how to do so with ease in this article.

A proactive approach to maintaining optimal room temperatures will help your facility stay compliant with the pharmaceutical regulatory requirements in pharmacy, laboratory, and hospital settings. The USP guidelines call for specific temperature conditions that ensure the integrity and efficacy of medications, vaccines, and other vital assets. Climate control also plays an integral role in testing accuracy and keeping samples free of contamination.

With a clear strategy and the right tools, your team can create an effective plan that meets requirements and helps ensure your critical assets are protected. Here’s how:

Understanding USP Guidelines

The USP sets public standards that intend to ensure the quality, safety, and benefit of medicines and foods. The primary USP controlled room standard for facilities to understand is USP 797, which specifies that clean rooms should be kept at a temperature of 68 °F (20 °C) or below, however, full compliance depends on the type of facility.

Pharmacies, laboratories, and hospitals all have similar responsibilities when it comes to pharmaceuticals. However, the type of medications used within a facility can vary greatly. For example, oncology treatment centers will have different requirements than a typical neighborhood pharmacy due to the types of medications used, the administration methods of medications, and the disposal of associated medical waste.

Knowing the Primary Concerns and Consequences

The overall aim of USP compliance is to contribute to patient safety. The millions of medications created on annual basis in the U.S. include oral, subcutaneous, intravenous, and those directly injected for localized treatment, as in the eye or spine. Complying with standards such as the USP guidelines provides assurance that patients receive medications of the correct potency and free of contamination. A guiding principle for climate control is that patient safety is the primary concern.

Steps to Maintain USP Controlled Room Temperature Compliance

As with any component of facility operations, there are several steps to take towards a focused USP controlled room temperature strategy. Your team will want to assess everything that plays a part in climate control, including the temperature and humidity parameters set by regulations and the measures available to monitor conditions.

Your strategy should cover the following topics:

  • Temperature and humidity range for all room types. For example, the USP 659 guidelines include specific ranges and definitions of room types including: cold (not exceeding 46 °F or 8°C), cool (between 46 - 59 °F or 8 – 15 °C), warm (between 86 – 104 °F or 30 – 40 °C), and excessive (above 104 °F or 40 °C).
  • Survey of the climate control systems in your facility. Work with the facilities manager to identify all of the relevant climate control systems and components. This should include equipment, condition, maintenance schedules, and any necessary upgrades.
  • Methods and tools for climate monitoring. This step is especially useful to help identify monitoring and documentation methods, responsible personnel, training programs, and any inefficiencies that can be improved upon by migrating to an automated documentation system.
  • Protocols for managing temperature and humidity irregularities. Map out the parameters for different climate requirements, how those settings are controlled, and which staff oversees the response to any changes that could affect program goals.
  • Schedule of system checks and guideline updates. When all of the systems, personnel, and proper climate settings are identified it is crucial to create a resource that keep track of monitoring activities, establishes regular monitoring documentation schedule, and includes a communications protocol that allows the most current information and regulations to be implemented in your facility.

Once you’ve established a clear strategy, each component can be assigned to a dedicated team member who will be responsible for its maintenance. These team members can then manage the relevant goals and tools to ensure compliance.

In order to keep your strategy on track, it’s important to create detailed protocols for each of the topics. These should cover the responsible staff, the current resources available, and timeframes for all required maintenance and monitoring.

Defining Your Toolkit

Within your facility strategy, the methods and measures available to staff to help track USP controlled room temperature include tools for climate monitoring and documentation. The Primex OneVue Sense system provides the climate monitoring tools that are crucial to track USP controlled room temperature. Combined with a clear strategy that outlines environmental conditions, OneVue offers a variety of temperature and humidity sensors to monitor the ambient climate as well as targeted temperature storage settings. The OneVue Monitor software then logs changes that could put your USP controlled room temperature compliance at risk and can automatically alert the relevant stakeholders to when temperatures fall above or below a certain range. This makes both documenting and resolving any errors as seamless as possible.

Whether your facility is preparing for increased patient volume or new medications and vaccines, the ability to stay compliant and keep staff and patients safe is well within reach. Learn more about how automated monitoring systems can help you with USP controlled room temperature compliance by reaching out to a Primex representative today!


U.S. Pharmacopeia General Chapter 797

NIH: Time and Temperature Controlled Transport

January 22, 2021
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