Clean Room Certification - Part 2
By Ralph McBride, MBA, BS Pharm, RPh, BCSCP, HDDP, Pharmacy Surveyor
and Wayne A. Copeland, CEO, CEPA Operations, Inc., and CETA Past President
We continue our look at pharmacy clean room certification requirements that often need further clarification. This article focuses on the dynamic smoke study test.
In the current version of USP <797>, the chapter requires “in situ air pattern analysis via smoke studies shall be conducted at the critical area to demonstrate unidirectional airflow and sweeping action over and away from the product under dynamic conditions.” Within the industry, this study is often called the "dynamic smoke study" or the "smoke study."
Regardless of the name, the requirement to perform the smoke study at each certification is often not performed or performed under conditions not consistent with USP <797> requirements. As such, it becomes a finding from the accrediting or regulating body.
Why is this test required?
There are several reasons why this test must be conducted:
- The purpose of this study is to demonstrate the optimal layout and usage of unidirectional airflow, also known as first air, during the compounding of sterile preparations. In the typical primary engineering control (PEC), air velocities range from 80 to 100 feet per minute or 1.3 to 1.7 feet per second — about four to six times the walking speed of a turtle. At this speed, you can better understand how external forces might impact the quality of first air and potentially compromise the environment's quality during compounding.
- USP <797> has made it a required test that must be performed by a qualified individual no less than every six months.
- Smoke studies provide useful information on first air and how it is impacted by the compounding technician, installed equipment, and placement of materials within the PEC. Having staff observe this test and review video documentation of the test is an important learning tool.
Who must participate in the test?
USP <797> states that the smoke study test shall be conducted under dynamic conditions. This means that the usual number of clean room personnel should be present and performing or simulating the normal type and volume of activity with the typical quantity of supplies. This represents the actual conditions in which the PEC will be used. The certifier is expected to ask the pharmacist in charge to ensure these conditions are confirmed during the testing process.
What must the certifier report?
The certification vendor is required to provide a report that includes:
- Observed airflow patterns. (The report should use phrases such as “minimal turbulence,” “without backflow,” “without refluxing,” “without re-entrainment,” “without dead spots.”)
- A definitive statement of acceptability for the intended purpose (e.g., “pass” or “fail”).
- The identity of unidirectional airflow within the direct compounding area (DCA), along with the aseptic technique performed by compounding personnel.
- A video recording of the test. (Video documentation of this test is not required in every state, but is considered a best practice and should be provided. Where allowed, a written report is adequate if all previously listed criteria are met.)
How can this test help improve internal processes?
A best practice is to have the dynamic smoke pattern test observed by staff who perform and oversee compounding. This test will provide insights on how to keep first air in the DCA, which includes establishing strategies for:
- Determining the best location to perform compounding (i.e., the DCA location).
- Determining the impact of all movement on first air within the PEC.
- Introducing items into the PEC.
- Placing items within the PEC.
- Minimizing the quantity of items placed within the PEC.
- Determining where to unwrap compounding materials within the PEC and where to place waste.
Bottom line: The dynamic smoke study test is a required component of the clean room certification process. It must be conducted in every PEC and must involve staff using the PECs. During the test, staff must simulate or perform typical compounding procedures with equipment normally used for those procedures. The goal is to educate staff on proper processes to ensure the DCA is bathed in unidirectional air.
➡️ Read Part 1: Clean Room Certification Critical to Operations
➡️ Next month, our article will focus on methods to test the integrity of HEPA filters inside the clean room.
For more information, please contact your Account Advisor, email customerservice@achc.org, or call (855) 937-2242, ext. 458.
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