The 2011 USP <797> Compliance Study: Additional Results


November 2011 - Vol. 8 No. 11 - Page #90

Following seven years after the initial publication of USP Chapter <797> and three years after the first revision, the inaugural USP Chapter <797> Compliance Study was published in the October issue of Pharmacy Purchasing & Products and is available online at www.pppmag.com/ComplianceStudy. The comprehensive results from this survey not only provide data to measure the success of pharmacies’ efforts in complying with sterile compounding requirements, but also offer access to the tools necessary to continually improve sterile compounding practices.

As the goal of this study is to continue to identify those areas that need closer attention and to provide the guidance and resources necessary to achieve full compliance, throughout the course of the year, additional results from this groundbreaking study will be shared on the pages of PP&P

Monitoring Airflow
For facilities with both buffer and ante-areas, USP <797> states that a “pressure gauge or velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area. The results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be at least daily) or by a continuous recording device. The pressure between the ISO Class 7 and general pharmacy area shall not be less than 5 Pa (0.02 inch water column). In facilities where low- and medium-risk level CSPs are prepared, differential airflow shall maintain a minimum velocity of 0.2 meters per second (40 feet per minute) between buffer area and ante-area.”1 Just under half of all facilities with buffer and ante-areas are currently measuring their pressure differential or airflow velocities daily (see Figure 1). A barrier to compliance might be related to older compounding suites that were built without a magnehelic gauge. Fortunately, the solution is simple and inexpensive; a magnehelic gauge costs between $55-$85 (plus the cost of the tubing and mounting bracket) and installation requires one to two hours of labor. Contact a reputable cleanroom builder if you are interested in adding magnehelic gauges to measure pressure differentials in your sterile compounding facility.  


Line of Demarcation
Surprisingly few facilities have placed a line of demarcation in the ante-area or segregated compounding area (SCA) to visually separate the dirty area from the clean area. The 2008 revision expanded the line of demarcation requirement to cover areas where CSPs with 12H BUD are produced, as well as SCAs. However, just 48% of facilities are in compliance with this requirement. This low rate may reflect facilities that have not yet brought their SCAs into compliance. A line of demarcation serves as a point for cart and material exchange and is a simple but effective mechanism in the overall effort to reduce particulates. The line demarcates the point at which only items that have been cleaned can pass, but the exact placement of the line will depend upon the location of your sink within the ante-area, as well as your specific garbing order (generally dirtiest to cleanest). Many pharmacies have had success installing a line of demarcation about halfway across the anteroom, leaving sufficient space for a “dirty cart” as well as adequate room to don PPE. Ideally the line of demarcation shoulde be integrated into the flooring during a new build or retrofit, otherwise it can be installed simply and inexpensively using cleanroom tape. 

Reference

  1. United States Pharmacopeial Convention, Inc. <797> Pharmaceutical Compounding—Sterile Preparations. United States Pharmacopeia 34-National Formulary 29. Rockville, MD: US Pharmacopeial Convention, Inc. 2011.

Kate Douglass, MS, RN, APN,C, CRNI is the president of Performance Strategies, Inc. Eric Kastango, RPh, MBA, FASHP is the president, CEO, and owner of Clinical IQ, LLC. Both Kate and Eric serve as the study directors for the 2011 USP <797> Compliance Survey. Peter Cantor and Max Shevitz of CriticalPoint, are the study coordinators. Address correspondence to Kate Douglass at kdouglass@performancestrategies.info

 


Sterile Compounding Resources

AseptRx  
http://www.aseptrx.com/  Tel: 866.772.0768 

  • Live program in sterile compounding 

American Society of Health-System Pharmacists  
http://store.ashp.org/  Tel: 866.279.0681 

  • Video Training Series (DVD and Workbooks) 
    • Compounding Sterile Preparations: ASHP’s Video Guide to Chapter <797> 
    • Basics of Aseptic Compounding Technique 
    • Getting Started in Aseptic Compounding 
    • Getting Started in Non-Sterile Compounding 
    • Safe Handling of Hazardous Drugs 

Baxa Corporation  
http://starcenter.baxa.com/  Tel: 877.395.2292 

  • Aseptic Processing and Compliance Tools for USP <797>; 3 day live course; (ACEPE 21 hours including 1 hour law credit)
  • Safe Handling and Preparation of Cytotoxic and Other Hazardous Drugs; 1 day live course (ACPE 8 hours) 

Clinical IQ, LLC  
www.clinicaliq.com  Tel: 973.765.9393 

  • Comprehensive and detailed policies, procedures and forms n Sterile and Hazardous Drug Compounding 

CriticalPoint, LLC  
www.criticalpoint.info  Tel: 240.238.4352 

  • Online training for individuals or groups in the following: 
  • Sterile Compounding (32 hours ACPE approved CE) 
    • Basic Compounding Skills 
    • Environmental Sampling 
    • Compounding Practices 
    • Engineering Controls 
    • Hazardous Drugs 
  • Virtual Compounder Series (10 virtual reality skills; 10 hours ACQE approved CE) 
  • Pharmacy Math Skills Course; Pre-employment Math Screening and Competency Tool 
  • Nuclear Medicine Course 

Medisca Network, Inc  
http://www.medisca.net/cen/cont_course4.aspx  Tel: 866.333.7811 

  • Essential Elements of Compounded Sterile Preparations 
  • Combination of Self-Study and 3 day live program 
  • 50 hours ACPE approved CE (30 for live and 20 for self-study) 

TRINU Healthcare  
www.trinu.com  Tel: 817.265.7524 

  • Sterile Pharmaceutical Compounding for Pharmacists and Technicians 
  • Live and home study portions 

Pharmacy OneSource 
http://www.pharmacyonesource.com/applications/simplifi797/  Tel: 800.654.8395 

  • Web-based USP 797 quality system with integrated expert rules 
  • System includes a complete set of policies and procedures 

     

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