Q&A with Kym Faylor,
President of Azzur Labs, LLC
Pharmacy Purchasing & Products: What is the purpose of the new guide, CETA Certification Application Guide: USP <797> Viable Environmental Sampling & Gowning Evaluation CAG-009?
Kym Faylor: The guide was released in January of this year with the objective of establishing an industry-based methodology for complying with the environmental sampling requirements addressed in USP <797>. It is intended to assist certification professionals, compounders, and facility managers in determining appropriate procedures for environmental sampling and gowning evaluation. Ultimately, the guide will contribute to establishing a uniform approach to testing activities.
PP&P: What new information is included in CAG-009?
Faylor: The material in CAG-009 is currently available in the USP <797> document; however, CAG-009 clarifies ambiguous points and provides a step-by-step procedure to ensure compliance.
For example, the new guide expands on the development and implementation of a robust sampling protocol. Your protocol should serve as a comprehensive guide that describes the program and delineates the sample equipment that should be used, as well as the correct procedures to employ for laboratory analysis and in response to exceeded concern levels (ECLs). Interim levels for ISO-classified rooms are listed in USP <797>. Laboratory results that indicate levels of recovered microorganisms above this interim or facility-established level, or if recovered organisms fall into any of the listed categories, indicate a loss of control for the facility and require immediate correction. Such responses usually include remediation of the area and resampling to show that the facility has returned to a state of control. An investigation into the cause of the loss of control must be documented, along with any newly implemented procedures to prevent the episode from reoccurring.
CAG-009 delves more deeply into laboratory procedures for evaluating microbial growth and media integrity. Consistency in evaluation processes means that pharmacy can compare intra-facility data and ensure that appropriate, identical procedures are being followed across the board. The guide also addresses sampling procedures within isolators. Compounding aseptic isolators and compounding aseptic containment isolators should be evaluated in a manner similar to that for sampling other locations, but information about how to address specific problems that may be encountered when evaluating these engineering controls are included in the new guide.
Keep in mind that pharmacy is accountable for ensuring compliance with USP <797>. Even if some or all of the requirements to achieve compliance are outsourced, pharmacy still bears ultimate responsibility. Pharmacy can insist that their outsourcing companies test and analyze the samples in accordance with CAG-009. With the new CETA guide, pharmacy can increase their expertise and ease the journey to compliance.
PP&P: What factors should be taken into account when choosing air sampling testing tools?
Faylor: There are several important considerations in choosing a device, including flow rate, volume, calibration and maintenance requirements, and cost. The sampler should have a flow rate high enough to sample the required volume of air without drying out the media, and should be equipped with a volume selector. When evaluating air samplers, a few questions must be answered: What type of media is needed? Is it readily available? Can the media be used to sample other areas, or is it specific for that sampler?
The sampler should be portable, easily disinfected, sturdy, and manageable. If complicated manipulations are required to load the sampler, there is an increased risk of contamination by the operator, so ensure that calibration services are readily available. Recalibration should occur as directed by the manufacturer, typically every six months to a year. Finally, the unit should be easy to maintain, cost-effective, and ISO-compatible. ISO compatibility, or validation, is completed by the manufacturer of the sampler; be sure to request a copy of the compatibility study.
PP&P: Where can pharmacy directors read CAG-009 and other CETA guides in their entirety?
Faylor: If your cleanroom certifier is a CETA member, he or she can download the guides and share them with you free of charge. Otherwise, the guides are only available directly through CETA International. Contact CETA at 919-861-5576 or email@example.com to request the guides.
Kym Faylor is the director of Azzur Labs in Schnecksville, Pennsylvania. She has fifteen years’ experience managing a microbiology laboratory and assuring compliance with governing agencies, client specifications, and developing quality assurance aspects to conform to current advances in the pharmaceutical, medical device, and biotechnology industries. Kym can be reached at Kym.Faylor@AzzurLabs.com.
To view an excerpt from CAG-009, Sampling Procedures Specific for Isolators—CACI & CAI, go to: http://www.pppmag.com/newCETAguide