As hospital pharmacies incorporate the environmental requirements from USP and NIOSH, compounding operations have become increasingly more sophisticated, underscoring the need for qualified cleanroom certifiers. In the July 2009 issue of Pharmacy Purchasing & Products, I detailed considerations for choosing a vendor to certify your cleanroom and other engineering controls used in sterile compounding processes. At that time, the considerations were designed to offset the lack of a certification program for individuals who certify cleanrooms, isolators, and other engineering controls. To address this challenge, the Controlled Environment Testing Association (CETA) is now developing a certification program for hospital pharmacy cleanroom certifiers. With the CETA certifier accreditation program ensuring baseline qualifications, hospital pharmacists will be able to identify qualified certifiers with confidence and ease.

Establishing Certifier Primacy and Capacity
The CETA certification program recognizes that one of the first steps in properly identifying a bona fide certifier of sterile compounding engineering controls is to define the role. CETA’s program is designed specifically for the certification professional specializing in sterile compounding facilities. Of note, this program does not address engineering control certification for devices such as BSCs and CAI/CACIs. You should still seek NSF accredited technicians to certify these controls.

The importance of verifying the performance of the primary and secondary engineering controls is fully recognized by USP Chapter <797>. The chapter states “PECs (LAFWs, BSCs, CAIs, and CACIs) and secondary engineering controls (buffer and ante-areas) are essential components of the overall contamination control strategy for aseptic compounding. As such, it is imperative that they perform as designed and that the resulting levels of contamination be within acceptable limits. Certification procedures such as those outlined in ‘Certification Guide for Sterile Compounding Facilities’ (CAG-003-2006) shall be performed by a qualified individual no less than every 6 months and whenever the device or room is relocated or altered or major service to the facility is performed.”¹ The document referenced herein, CAG-003-2006, is the basis for the CETA certifier accreditation program.

Developing Testing Criteria
To assist them in the certification examination development, CETA contracted with Professional Testing, Inc, which is overseeing the development of the examination item banks, the assembly of test forms, and the scoring procedures. Professional Testing’s role is to assure the written tests are job-related, reliable, and valid. As a result, the certification examination is being developed in accordance with ISO/IEC 17024 Accreditation Standards for Personnel Certification as administered by the American National Standards Institute (ANSI).

The certification program includes both a written and a practical test. The written portion has been developed with the assistance of a beta testing group. The test was administered to this group and the results were used in determining pass/fail criteria for future testing. A second round of written tests is being administered to further refine the criteria. The content of these test questions was established through an exhaustive analysis of certifier job tasks. This process included working with certifiers to observe their real-world practices. The job analysis determined the following key criteria on which the test questions are based:

• Understanding the facility requirements
• Counting total particles (determining cleanliness class)
• Performing environmental monitoring
• Determining air exchange rates
• Testing airflow velocities
• Proving room segregation
• Testing HEPA filters
• Performing airflow visualization
• Preparing certification reports

The next step in the certification process is the practical test, which combined with the written portion will prove the candidate understands all aspects of cleanroom certification germane to sterile compounding. The practical test will demonstrate how the certifier applies the fundamentals displayed in the written test to real life situations. Examples of practical test challenges include demonstrated knowledge of, and ability to use all required equipment in actual field conditions.

Current dates and locations for the Cleanroom Certification Professional—
Sterile Compound exam can be found at www.cetainternational.org. As part of the program, CETA plans to publish a list of certified certification professionals by July 2011.

Compliance Steps You Can Take Now
In light of this established credentialing process, pharmacists should insist that a properly certified individual perform cleanroom certification of all USP Chapter <797>-compliant facilities. Until the certification program is officially in place, there are steps that can be taken to ensure a minimum level of competency. First, ask for your certifier’s training records, as they should be able to provide an extensive list of recent training activities. Much of what is being asked of certifiers is no different than what they have been doing for years; however, the exact applications of many testing procedures are new since 2008. It is important to confirm that the certification company maintains an understanding of currently validated practices. Ask for your certifier’s test equipment calibration certificates. This equipment should be calibrated no less than annually, demonstrating consistent maintenance.  

Review the report provided at the end of the certification. If you cannot understand the report or cannot tell if any aspect of the certification process is out of compliance, the report is inadequate. A professional certification report should be complete and easy to follow. It should not require any guesswork to determine what was done and whether the results are satisfactory. If you are not satisfied with any of these items, look into a replacement provider. Working with established and well-documented certification professionals is vital to all sterile compounding operations.

Conclusion
As with any position that requires a great amount of skill and attention to detail, there can be a significant gap between the best certifiers and those that would be better off doing something else. For now, due diligence and common sense are the only tools available to ensure you are using a minimally qualified individual for what is an extremely important task. Having the ability to verify minimum certifier knowledge through the CETA certifier accreditation program will bring much needed peace of mind to ensure the integrity of your CSP operations.

Reference

1. USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations. US Pharmacopeia; February 2008:p.45.

James T. Wagner, principal of Controlled Environment Consulting, has over 30 years experience designing and evaluating facilities used for aseptic processing. He was a member of the 2005-2010 USP Sterile Compounding Committee responsible for Chapter <797>.