Clean Room Certification - Part 4

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, the last in the series, focuses on staff attendance and participation during the certification of the clean room and the importance of reviewing the certifier’s final report regarding compliance with USP <797>.

USP <797> requires that the testing of ISO Classified primary engineering controls (PECs) and secondary engineering controls (SECs) and tests of airflow visualization, or “smoke study” tests, in PECs be performed under “dynamic operating conditions.” Dynamic conditions, although not defined in the 2008 version of USP <797>, are defined by the Controlled Environment Testing Association (CETA) as the actual conditions in which the engineering control is used. During these tests, all regular personnel are to be present and performing actual or simulated operations.

Why are dynamic operating conditions important?

Testing PECs and SECs to their relevant ISO Classification under dynamic conditions ensures that the areas adhere to the intended classification and maintain a “state of control” during normal operations. Testing the unidirectional airflow, also known as “first air,” in a PEC under dynamic conditions considers the process being performed, staff technique, PEC operation, and the potential impact of all associated equipment and supplies inside and outside the PEC.

Who must be present during tests?

All normal personnel should be present and performing actual or simulated operations during tests conducted under dynamic conditions. For example, if your maximum occupancy is three compounding personnel in the buffer room at any given time, you should have three compounding personnel in the buffer room performing or simulating their required tasks using the equipment they normally use.

Also, if you typically have one person performing compounding, it is not permissible to count the certifier as that one person for occupancy, since the certifier is not simulating the compounder's everyday activities.

When performing an airflow visualization test, it is best practice to record and review it with pharmacy staff. A video of the test can help you determine optimal equipment and supply setups based on airflow patterns within the space, educate staff on the effects these items have on first air and identify the direct compounding area (DCA).

After receiving your certification report, what should you do with it?

USP <797> requires all certification records “be maintained and reviewed by supervising personnel or other designated employees to ensure that the controlled environments comply with the proper air cleanliness, room pressures, and ACPHs [air changes per hour]."

A best practice is to have a designated person review the report and transcribe the required elements to a summary document. (A sample “Certification Review and Summary Report” document from the upcoming “ACHC PCAB Compounding SOP Manual” is available here.) After ensuring that controlled environments comply with USP <797>, the completed summary document must be signed, dated, and kept on file with the clean room certification report.

Bottom line: “Dynamic conditions” are more than words on a certifier's report. They indicate that the proper number of staff were present during data collection for determining compliance with the stated ISO Classification of a PEC or SEC. It is essential to ensure staff performs or simulates tasks they typically perform using equipment they normally use. This also applies to airflow visualization testing of the PEC. Use data presented in the certification and certification summary reports to educate staff, with a goal of continuous quality improvement.

➡️ Read Part 1: Clean Room Certification Critical to Operations

➡️ Read Part 2: Clean Room Certification - Dynamic Smoke Study Test

➡️ Read Part 3: Clean Room Certification - HEPA Filter Integrity Test

For more information, please contact your Account Advisor, email customerservice@achc.org, or call (855) 937-2242, ext. 458.

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Some content presented in 'Did You Know?' may consist of timely or topical articles deemed to be of interest to the provider community. These are presented for informational purposes as a service to our readers. The views, opinions and positions expressed by the authors are theirs alone, and do not necessarily reflect the views, opinions or positions of Accreditation Commission for Health Care, its related entities or any employee thereof.