USP 797 Cleanroom Performance

USP General Chapter <797> or USP 797 provides standards for compounding sterile preparations to promote patient safety and prevent harm. These standards help ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency.

USP 797 defines a number of requirements including:

• responsibilities and procedures of compounding personnel
• expectations for sterile preparation
• training of USP 797 cleanroom personnell
• environmental monitoring of the USP 797 cleanroom environment
• storage and testing of finished preparations

USP 797 cleanrooms require a high level of rigor and protocol to ensure a high performing aseptic compounding cleanroom. There are many things that you, your pharmacists and your cleanroom operators can do to ensure a compliant USP 797 environment.

USP 797 Training and Preparation

Ensure that your cleanroom personnel has the appropriate training and equipment necessary to operate under the protocol established in USP 797. Clear communication and documentation of practices is essential to ensuring compliance. Be sure that the cleanroom has a dedicated cleaning schedule and service.

Be ready for variability

Your ability to maintain a safe and high performing cleanroom environment relies on your ability to mitigate risk and identify any potential hazards that could come in to play. Prepare for the worst, always. Be aware of the risks associated to your cleanroom environment, possible causes of contamination and contingency plans for reacting to these situations. Schedule regular maintenance on cleanroom equipment and/or instruments to reduce downtime due to malfunctions.

Pinpoint Redundancies

Along with being proactive about your workspace, taking time to identify and eliminate workflow redundancies can help your entire team create more product more efficiently.

Overproduction is a major cause of production backflow, as well as product waste. This means that trimming the excess from your workflow processes can save your team time, reduce overuse of materials, and ultimately save your company money.

Collect, Analyze and Interpret Data

It is important to measure and seek to understand any data collected, as it pertains to your cleanroom and its processes. Using collected data to better understand your team’s work output and production costs can help you devise safer, faster and more efficient ways to get the job done. You can think of this measured data as a means of creating useful key performance indicators for you and your teams.

Practice Agile Methods

Understand your current state and where you need to be to be considered operating at 110% and at high performance. If you understand the gaps of your environment, you can through iterative approaches, enhance the techniques, capabilities and protocol of your environment and your staff. Identify quick wins and plan for increased operational capacity and high performance.

Build Talented Staff and Foster Talent Development

Your most valuable asset in a cleanroom is your people. Your people are the most important part of creating a high performing aseptic cleanroom environment. Ensuring that your people are trustworthy and understand the importance of following proper protocol is essential to running a compliant USP 797 cleanroom operation.Consider including periodic training sessions, certification renewal requirements, and incentives for employees who proactively spot defects and redundancies within workflows. Furthermore, it helps to foster a culture of co-workers who want the best for their teams and the company at large.

Recognize a job well done. Keep your cleanroom staff motivated with positive reinforcement and recognition.