(CNBT) accreditation for certification of sterile compounding facilities . You are responsible to ensure that your facility is being tested to appropriate standards by qualified technicians. Both of these accreditation programs are intended for the technicians who are working in the field, not the company management. Insist that the technician on site is accredited, not just his or her manager, who is back at the office. At a minimum, at least insist that the on-site supervisor is properly credentialed. USP <797> has stated “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” since 2008. This is one of the most important and critical tests that a certifier performs on unidirectional airflow equipment. This is a dynamic test that should be done with the actual compounding personnel performing simulations of genuine compounding operations. If you or your certifier have not been doing this simple but critical test, you are not in compliance with USP <797> requirements. Airflow smoke pattern testing and particle counting within the primary engineering controls are dynamic tests that will require interaction between the certifier and the compounding staff. Certification is no longer time for pharmacy personnel to go on break. Parts of the certification process are best done with collaboration between the certifier and staff. There is no training that can teach as much about unidirectional airflow, and how to use “first air” as participating in a dynamic smoke study. This test “shall” be done anyway, so you might as well take advantage of the opportunity to learn how to best use your laminar flow equipment. I promise you that if you have not already participated in this process, you will find it to be an enlightening experience. Don’t be fooled by an attractive, well-formatted test report. With today’s computers and software, producing a nice looking report is not impressive. Creating a professional certification document that provides adequate proof of compliance to the facility requirements of Chapter <797> is impressive and what you should expect. Get a free copy of CAG-008 and look over your documentation. If you cannot identify the critical elements of a certification laid out in CAG-008 on your certification report, it might be time to look for a new certifier. Controlled Environment Testing Association, 1500 Sunday Drive, Suite 102, Raleigh, NC 1500, 919/8611-5576, www. cetainternational.org www.nsf.org CETA National Board of Testing, www.cetaboardoftesting.org Jim Wagner, the president of Controlled Environment Consulting (CEC), has over thirty three years’ experience assuring the performance of critical environments. His consulting includes design and evaluation of sterile compounding facilities, containment facilities and other engineering controls. Jim conducts international training on cleanroom and containment device certification. Recently Jim led the Controlled Environment Testing Association’s (CETA) efforts to develop guidance documents for USP Chapter 797. He is a current board member for the Controlled Environment Testing Association and served as president in 1992-1994 and 2006. iii i ii iii
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