usp 797 guidelines

November 27, 2019

Here’s Everything You Need to Know About USP 797 Guidelines

Recently, the USP-NF announced it was postponing some updates, including changes for USP 797.

The updates were supposed to take effect on December 1, 2019. Many pharmacy personnel were wondering what changes they’d need to make. What do the current USP 797 guidelines say about compounding environments anyway?

If you have questions, this guide has the answers you’re looking for.

What Does USP 797 Cover?

The United States Pharmacopeia 797 guidelines prevent harm from compounded sterile preparations. CSPs prepared improperly can cause harm or even death. Preparation in improperly controlled environments can also cause negative outcomes for patients.

Chapter 797 covers many standards and precautions to protect patients.

The standards are considered the minimum for practice and quality. They’re based on both current best practices and scientific information.

The proposed update to USP 797 standards would be the first in over 10 years. The update has been postponed indefinitely. The USP is hearing appeals about:

  • whether the rules apply to veterinary practitioners;
  • the use of equivalent alternate technology; and
  • beyond-use dating.

Until the appeals are resolved, the 2008 version of USP 797 is in effect.

The Basics of Quality Control

The USP 797 guidelines create a framework for quality control. The rules cover five key elements:

  • Facilities and equipment 
  • Environmental monitoring
  • Personnel training
  • Work practices
  • Certification

The USP outlines standards for each of these areas. While the rules are strict, the goal is to create safe, clean environments for compounding.

Facilities and Equipment Standards

The USP guidelines focus on primary engineering controls for facilities. The purpose is to ensure the site is designed to limit contamination.

An example is the use of compounding aseptic isolators or laminar flow air workbenches. Unidirectional airflow is required to prevent contamination.

Biological safety cabinets are also required within a cleanroom or segregated compounding area. The compounding facilities also need to be well-lighted and comfortable for personnel.

For hazardous sterile compounding, an anteroom with positive pressure must be used. There must also be a buffer room with negative pressure. USP 800 describes even more rigorous requirements for facilities dealing with hazardous compounding.

Airflow is incredibly important since it can reduce contamination. Proper airflow and the use of HEPA filtering limits particulate matter in the air. It also helps maintain required pressure differentials.

Other considerations include sink placement and finishes. Furniture must be limited to only that needed for compounding.

The focus is on creating rooms that are easy to clean and disinfect.

People and Practices

Of course, the pharmacy cleanroom is only sterile until someone enters it. You must train and educate your staff to ensure the room remains free of contamination.

To that end, USP 797 includes information on training and work practices. The USP 797 requirements for training include:

  • Hands-on training provided by an expert compounding professional
  • Ongoing training for new procedures
  • Remedial training to address issues around garbing, procedures, and equipment use
  • Requalification

You’re required to keep documentation of all training. Physical tests are required for certification.

Working Safe and Smart

The guidelines also go over good work practices. These help ensure the quality and safety of CSPs prepared in any cleanroom.

Policies and procedures must address everything from monitoring pressure differentials to assessing risks.

CSPs must include beyond-use dates. BUDs are determined when the compound is prepared.

Proper clothing and personal protective equipment is key to keeping your staff safe. Personal hygiene is also mandated. Both play a role in creating a sterile environment.

Finally, you must pay attention to cleaning and disinfecting. You should outline procedures to be followed, as well as best practices. Your team should be trained to disinfect and clean the room the right way.

USP guidelines require daily disinfection of all floors and work areas. You must also disinfect and clean equipment. This includes equipment like telephones that may be in the room.

Monitoring Your Environment

Precise conditions are needed to maintain sterility. That’s why it’s important to keep an eye on your environment. The USP 797 guidelines make monitoring a rule.

You must perform viable air testing once every six months at least. Surface sampling must be performed monthly.

A good practice is to have an outside certifier perform the tests every six months. In the intervening months, your certified personnel can conduct the tests. This creates a system of checks and balances, as two labs review the results.

If tests uncover any growth, you must take corrective action. Good record-keeping is essential for this reason.

Pressurization is one area to monitor closely. Too much negative pressure, for example, can draw in dirty air and cause contamination. Maintaining differential pressures can be challenging.

Sensors can help you maintain the right conditions for the sterile cleanroom. They also supply excellent record-keeping.

Getting Certified

Every six months, your sterile facility must be certified by an independent party.

The certification report must show which areas pass, fail, or need attention. It should document airflow testing, HEPA filter integrity, particle counts, and more.

The certification process must happen under dynamic conditions. You and your team should be ready to simulate compounding. You may need to perform a cleaning to create “at work” conditions for the test.

Becoming Compliant with USP 797

The 797 requirements apply to a wide range of facilities, including:

  • Hospitals
  • Long-term care facilities
  • Retail stores

Ambulances and other facilities can be included if they deliver CSPs.

The USP 797 requirements are enforced by law. Surprisingly, not all facilities self-report compliance. That’s because the rules are demanding, and meeting them can be a challenge.

Protecting patients is important. All facilities that prepare CSPs should strive to meet or exceed the USP 797 guidelines.

There are many tools that can help. Some companies provide equipment and materials designed with 797 compliance in mind. Consultants can help you address areas of concern.

Set Sensors to “Upgrade”

If you want to improve your USP 797 compliance, think about your monitoring systems. The data you collect will help you learn where you can improve.

The latest monitoring technologies can help you do much more too. Learn about cloud-based solutions by talking to experts today.

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