It’s been nine months since the changes outlined in USP Chapter <797> took effect. Many hospitals adapted quickly and are discovering operational best practices to streamline their pharmacy workflows, but there are areas in which clinical directors are still seeking clarity.
Recently, Helmer Scientific partnered with Pharmacy Purchasing and Products (PP&P) to sponsor a webinar, where Patricia Kienle, director of accreditation and medication safety at Cardinal Health, discussed clean room compliance, design, standard operating procedures, and best practices.
Kienle explained several keys to safe sterile compounding. She claims effective clean room design starts with construction, but it should also include equipment, cleaning procedures, certification, environmental monitoring, and work practices.
Start with an Accurate Map
To start, Kienle called on providers to revisit the map from their certification report, stating, “When the certifier comes in, he (or she) should be dealing with a really adequate map that’s complete and correct and reflects all of the important things in your cleanroom.”
Your map should include things such as:
- Location of HEPA filters
- Locations of air and surface samples
- Placement of equipment, including key equipment, such as refrigerators and hoods, but also including IV workflow components, carts, etc.
An accurate map will help you make better design decisions. Kienle also warned original design plans sometimes are altered throughout the construction process, so it is important to ensure your reference map is accurate to the actual construction of the building, particularly regarding air handling, which is the most important aspect of clean room design and compliance.
Know Your Air Handling Systems
Understanding airflow in your clean room is critical for building work processes and for equipment placement.
Start by identifying the rooms’ exhaust and returns. In positive pressure rooms, returns are allowed, but in negative pressure spaces, everything needs to be exhausted outside the building.
Understanding the differences between the two environments and knowing where exhausts and returns are can help you make equipment decisions.
Place Equipment Strategically
Once you understand the air handling systems in your space, you can begin to plan strategically for equipment.
Kienle urges clean room directors to consider several factors.
The foremost consideration for any clean room space is the necessity of each piece of equipment inside. Since space will be at a premium, each piece of equipment should meet one of two requirements. It should be necessary to achieve cleanroom compliance or for operational efficiency.
For example, since the updates in November 2023, sinks are no longer required inside the clean room area. Removing or not including a sink in your clean room design could save you space.
She also mentions pre-mixed IVs and proprietary vial and bag components as examples of equipment that could potentially be moved outside the cleanroom to save space.
One piece of equipment Kienle does recommend planning to include is a refrigerator you can grow into:
“Make sure (your refrigerators are) appropriately sized and think in the future. You know, you don’t want to get things that are too big because they may take up too much space or generate heat, but make sure that you’re adequately handling and thinking about what you might be doing in the next few years because we don’t get our IV rooms changed every year, right?”
Kienle also advises placing your refrigerator in front of an exhaust vent to take away any particles that may be generated by the compressor.
Finally, Kienle discussed spacing for equipment, recommending pharmacy directors leave enough space in between pieces of equipment to ensure cleanliness.
Be Smart About Maintenance and Cleaning Policies
Kienle considers cleaning and maintenance procedures one of the keys to safe sterile compounding and reminds pharmacy directors to consider cleaning when planning the clean room space.
Kienle used the example of biological safety cabinets, which are required to be at least six inches apart according to standards. She argues, however, that six inches may meet compliance standards but will allow inadequate space for cleaning, which can ultimately jeopardize clean room compliance. She warned pharmacy directors to keep this in mind when placing large equipment.
Kienle also joked pharmacy directors should remember cleaning does not just apply to hoods and shelving, but to all equipment inside the clean room suite.
“…make sure that that refrigerator is kept clean. And a lot of times people miss that. They have immaculate rooms and hoods and shelving. And then you look at the refrigerator and go, ‘Wow, has somebody looked at this lately?’”
When in Doubt, Ask Your Certifier
Best practices for sterile compounding will continue to emerge and evolve as pharmacies adopt USP <797> standards and look for ways to further optimize workflows while maintaining requirements.
One of the most critical resources pharmacy directors have at their disposal, and one of the most underutilized according to Kienle, is the certifier. Your certifier will know what your air handling system can take, the design of the room, the workflow inside the clean room suite, and more.
Kienle encourages all pharmacy directors to use their certifiers as a resource any time they are considering a new equipment purchase or process change.
OTHER BLOGS YOU MAY BE INTERESTED IN...
- Interlock Pass-thru Pharmacy Refrigerators for Your USP <797> Clean Room
- Reducing Cold Storage Noise in the Pharmacy
- What is the Impact of Inflation in Pharmacy and How to Combat It
- Cold Storage Equipment Matters in Specialty Pharmacy Accreditation
Research Further
The full webinar is full of useful safe sterile compounding best practices is available on our website.
Throughout the webinar, Kienle reaffirmed the suitability of compressor-based refrigerators for clean room environments. To learn more about the suitability of compressors on clean room compliance, we developed a white paper.
