Choosing a vendor to certify your engineering controls has become even more important as choices in engineering controls have grown to include laminar airflow workstations (LAFWs), cleanrooms, biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), and ventilated balance safety enclosures (VBSEs). In addition, pharmacists and facilities engineers are faced with the daunting task of revamping their compounding operations to meet the environmental requirements of USP and NIOSH. An experienced, well-trained, and knowledgeable certification professional can provide invaluable insight to assist you through this process. Most certification companies are independent firms familiar with the equipment choices employed in sterile compounding facilities. Provided your certification company does not sell those engineering controls, it can help you filter through the contradictory claims you are sure to encounter as you weigh your options for gaining compliance with today’s standards.
Training and Experience
Experience alone is not an adequate gauge of a certifier’s expertise. A poorly trained certifier with 20 years of unsupervised experience will likely not do as thorough a job as a well-trained and well-supervised technician with two years of experience. Consider both the experience and training of the individual who comes to your site. It is only logical that the qualifications of the company president will not mean as much to you as those of the individual working on your equipment. Make sure the company’s training programs for technicians are thorough and well documented. If the company cannot provide you with training records for all of its technicians, consider it a warning sign.
Most certification companies participate in industry training programs offered by the Eagleson Institute, the Controlled Environment Testing Association (CETA), and many of the equipment manufacturers. For example, NuAire, Labconco, and other engineering-control manufacturers provide comprehensive and on-going training on their equipment. Some of the larger certification companies have begun to establish in-house training capabilities, often augmented by outside training centers providing hands-on training. These programs should be run by well-documented, qualified individuals.
Training is arguably the most important aspect to consider when choosing a certification company. Insist on a detailed set of training records as part of your due diligence. Certifiers should be accustomed to this request and are generally well prepared to respond to it. When reviewing training records, evaluate both initial and ongoing training. Engineering controls change constantly; therefore, what was good basic knowledge five years ago may be out-of-date today.
Make sure that your certification provider’s experience is relevant to your existing or proposed facility. The new facilities’ requirements in USP <797> include equipment that may not be familiar to your contractor. For example, it is not unusual for a certifier that has spent 20 years testing only pharmacy equipment to have little or no cleanroom certification experience. If you are installing a new cleanroom, have your certifier explain their experience certifying cleanrooms before assuming they are qualified. CAIs are relatively new to the US market, so they require an explanation of what the certifier has done to become familiar with that equipment.
Currently, there is only one accreditation program that applies directly to certifiers of sterile compounding engineering controls. NSF International provides accreditation for individuals certifying Class II BSCs. While not every pharmacy has a BSC, the principles used to certify a BSC apply to most of the engineering controls employed in pharmacy. Individuals accredited by NSF International have proven themselves competent to certify BSCs.
Certifying cleanrooms and CAIs is also essential for pharmacy since the adoption of USP <797>. At the moment, no specific accreditation program exists for certifiers of this equipment in sterile compounding facilities. CETA is the caretaker of the applications guides referenced by USP for sterile compounding facility certification, and is currently developing an accreditation program for certifiers of sterile compounding facilities, which is expected to be available in early 2010. Participation in any industry accreditation is not considered mandatory, but is a good sign that the certifier takes their trade seriously.
Your certification provider’s qualifications are best analyzed by looking at their past certification reports for completeness and accuracy. Are current certificates of calibration provided for test equipment used in the certification process? Ask about their report QA process: Are the certification reports reviewed, or is validated software employed to assure computational accuracy?
The certification report should include acceptance criteria for each test. A test that is not based on actual acceptance criteria has no regulatory value. The acceptance criteria for certifying an NSF-listed BSC is published and a professional certification provider will have access to that data.
Establishing a pass-fail criterion for cleanroom certification is more challenging, as it is often up to the end-user to assign appropriate performance criteria. This is where the value of an experienced and knowledgeable professional certifier is indispensable. Because cleanroom certification should be based on pre-established acceptance criteria, it is common for the pharmacist to look to the certifier to assist in assigning the criteria. The certification report should include unambiguous statements of pass or fail for every test, and for the cleanroom overall. (See the Cleanroom Certification Matrix starting on page 10 for guidance.)
A certification company should have a written QA program to ensure the quality of its work. At minimum, this should include a review of the test reports, maintenance of training programs, and calibration of the test equipment. Calibrating certification test equipment at the equipment manufacturer’s recommended interval is considered minimum acceptable practice. Because of the abuse certification equipment receives during travel from site to site, reduced intervals are recommended. This should be an influential differentiator when looking at competing firms.
Certification firms are often also called on to service the equipment they certify. Therefore, you want to verify that they have adequate staff to send someone to your facility within 48 hours of notification, or that they have a network of colleagues they can call on for help in an emergency. Include expected response times and parts availability parameters in your contract. Summary The price difference between the least and most expensive certifiers is often marginal, but the difference in professionalism may be dramatic. Remember that quite often, “you get what you pay for.” In summary, your certifier should:
- n Have written training programs
- n Provide a written documentation of participation in industry training and continuing education programs
specific to your equipment
- n Provide a written estimate and
schedule of work before work begins
- n Have adequate capacity to service its geographical territory
- n Provide complete, accurate, and professional documentation of its testing
- n Provide documentation of all stated accreditations (preferably at least NSF)
- n Have access to spare parts and
supplies, as needed, to keep your equipment operating
- n Provide a written QA program
- n Calibrate its test equipment to the
intervals at minimum, though
preferably more often
- n Have adequate liability insurance to protect your facility in the event of
James T. Wagner, principal of Controlled Environment Consulting, has over 25 years of experience evaluating facilities used for aseptic processing. He has served on many industry-standard writing committees, and is currently a member of the committee revising USP Chapter <797>.
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