• PharmacyWeek's Blog


February 19, 2018

By Luis Hernandez, BS Pharm, PRS

Sterile admixture managers (SAMs) are the pharmacy’s chief patient safety officers for sterile admixture dispensing in healthcare facilities. The complex array of processes: medication management, coupled with personnel, contamination, and engineering controls have a simple yet critical objective in mind: each compounded sterile preparation (CSP) is sterile and safe for human administration. The skill set that SAMs utilize represents an expansion of his or hers common pharmacist functions into a much broader, interdisciplinary field. SAMs are both operations as well as cleanroom managers.

Operations management includes drug and medical device acquisition, distribution and utilization. Also, medication management functions such as batch production, master formulations, beyond use date assignment and medication safety initiatives adopted by the institution are also in the mix. Personnel management is a most critical skill which will engage the SAM into selecting and validating new compounding staff and developing existing compounding technicians and pharmacists. Furthermore, SAMs administer core competency assessments and address the manner in which aseptic manipulative techniques apply to different dosage forms (intrathecal, irrigations, elastomeric container and automated compounding devices (ACDs). Quality assurance duties for the SAM involve documenting of
all tasks and processes.

Cleanroom management is not usually part of pharmacy school curriculums, and USP <797> is a regulatory document and not a textbook in cleanroom management. Therefore, the SAM acquires expertise via 797 training events, personal research of existing literature, and webinars by subject matter experts. Visiting a 503B out-source facility affords the SAM an opportunity for screening as well as learning. Cleanroom sanitization and environmental monitoring are also a great concern to the SAM. These are usually suffering from lack of proper training and weak budget allocation for the purchase of sterile disposables, as well as cleaning and disinfecting supplies. Moreover, understanding cleanroom design and construction allow the SAM to provide valuable feedback to architects and engineers who must design and build the new space to USP 797 and ISO specifications. The selection of cleanroom materials finishes, and furniture, as well as the proper placement of primary and secondary engineering controls, will affect how the ISO classified space maintains specified ISO conditions and endure the rigors of production without compromising air and the quality of the physical space. This knowledge will also assist the SAM in the selection of a qualified vendor of certification services.

Finally, SAMs have essential fiscal and administrative responsibilities that include policy review and creation, capital and operational budget allocation, computer downtime and change management, talent acquisition and participation in interdisciplinary committees.

We are now in the second decade of 797 regulations. Job descriptions for sterile admixtures supervisors must be updated to include specific responsibilities pertinent to sterile compounding. Hiring efforts into these positions must only open the door to candidates with a deep passion for compounding and as well an unwavering to quality.

Contact info:

Luis Hernandez, BS Pharm, PRS
Seven97 Training Solutions, PLLC



Note: This article is the sole property of Luis Hernandez/ Seven97 Training Solutions, LLC.
Created February 17, 2018


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  1. Anthony Schiro 9 months ago  

    Excellent article, filled with up to date information. I would love to see a career ladder and educational requirements for a pharmacy technician to fill this sort of role. Thanks.

    • pharmacyweek123 9 months ago  

      Anthony, thanks for taking time to comment, we appreciate that! We have emailed the author, Luis Hernandez, and will ask him to reply to your comments as well. Thanks again!! Kevin

  2. Luis Hernandez 9 months ago  

    Hi Anthony &Thanks for your comment. I am working on a series that can become what you’d suggesting. Maybe we can collaborate!
    Thank you.