On March 3, 2010, I attended a webinar hosted by Emlab P&K (http://www.emlab.com). The topic related to USP 797 and was presented by Joseph Manfrida PhD. For those not familiar with USP 797, here is a brief outline of what it is and how Environmental and Engineering Solutions can help you comply.
USP 797 is a set of guidelines for sterile compounding preparations prepared by the United States Pharmacopoeia. This organization is composed of industry leaders, regulators, and other pharmaceutical field leaders. The USP website (http://www.usp.org) describes itself in this way: The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States“.
This guideline is the first set of enforceable standards issued by USP. This guideline is applicable to any facility that produces Compounded Sterile Preparations (CSPs). If you are associated with a hospital pharmacy and compound substances onsite, USP 797 applies to you. If you run a small clinic which prepares compounded substances on site, this applies to you also. Because USP 797 applies to a wide variety of clinical settings, it is far reaching and may present difficulties for pharmacy supervisors to determine and achieve compliance.
USP 797 specifically establishes guidelines for sterility of the laboratory environment where compounding occurs. There are different standards of sterility for various lab areas. Some tests require air sampling for particles of various types and sizes. Other tests involve swab sampling. To determine whether personnel are performing according to sterility guidelines, USP 797 requires periodic monitoring of the practices of laboratory personnel.
For our more detailed blog post on this topic, click here.
If you are a hospital pharmacy supervisor or a hospital decision maker concerned about compliance, Environmental and Engineering Solutions, Inc. can help you determine if you comply with USP 797. EES can also establish testing protocols and procedures to document compliance with USP 797. We have vast experience in air quality testing and monitoring in sterile environments for hospital facilities. Please send Tom Petersen an email at tom@eesolutions.net or call us at 215-881-9401.