HealthMay 07, 2015

How to Identify USP Compliance Gaps within Your Cleanroom

Full compliance with USP Chapter 797 should is no longer viewed as a task that can be put off until a later date. Today, 24 state boards of pharmacy have the statutory authority to inspect and demand USP 797 compliance from facilities involved in compounded sterile preparations (CSPs). The FDA also actively inspects hospitals to determine their compliance level.

Your pharmacy's best approach is to become voluntarily compliant in the near-term, so that more stringent and restrictive compulsory compliance regulations will not be deemed necessary by state and federal regulatory bodies. Additionally, compliance helps your facility become a true patient safety advocate through adherence to best practices for compounding CSPs.

How can your cleanroom become compliant? The first step is to identify compliance gaps within your institution so that corrective actions can be taken. Following this gap analysis, there are excellent web-based software systems that can assist hospitals and staff involved in CSP to remain compliant and up-to-date with USP 797 requirements.

Gap Analysis Tool

An excellent gap analysis tool is offered through educational programming company Critical Point. It compares your operations with the requirements of USP 797. This tool asks you to answer a series of questions for the busiest sterile compounding location at your facility. The survey will require one to two hours to complete, but it is important you spend to ensure that your facility will pass state or federal inspections and most importantly, best serve your patients.

Some of the issues that may be covered in your gap analysis include:

1. Compliance with daily air pressure/velocity documentation requirements.

Hospitals with both ante and buffer rooms must have tools such as pressure gauges and clean lines of demarcation to be able to show compliance with this section dealing with physical facility metrics.

2. Cleaning and Disinfecting Activities.

The survey asks a number of questions in this area, including whether:

  • Walls, ceilings, emptied shelving, and supply bins are cleaned at least monthly with designated cleaning agent and documentation;
  • Sterile 70% IPA remains in contact with surfaces to be disinfected for 10 to 30 seconds before compounding activities begin;
  • Only trained compounding personnel clean inside of the ISO Class 5 work areas.

3. Environmental Sampling Plan.

Results of the 2014 Critical Point USP 797 Survey1 indicated that compliance is still low on some areas. here; Does your cleanroom's plan:

  • Include all of these: sample locations, method of collection, frequency of sampling, volume of air sampled (for viable air samples), time of day in relation to compounding and action levels?
  • Have current written documents on where viable air sample and surface sampling occurs within the controlled environments?

4. High-risk compounding and sterility testing.

For example, in facilities performing sterile compounding activities, USP 797 requires that when a 0.22 micron filter is used to sterilize solutions, a routine bubble point (i.e. filter integrity) test must be performed. According to the 2014 survey, only 42% of reporting institutions said they were compliant in this area.

Performing a gap analysis can help your hospital achieve compliance with the numerous requirements of USP 797. A web-based system can assist your compounding staff to easily manage tasks and schedules, maintain competencies via self-paced online learning, and stay current with updated standards.


1. Pharmacy Purchasing & Products, October 2014, Cleanrooms & Compounding. The 2014 USP<797> Compliance Study."
Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.