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USP 797—Best Practices
By Laura A. Thoma, Professor of Pharmaceutical Sciences, University of Tennessee Health Science Center
From Bioscience World, Summer 2009
IN THE REVISED Chapter of USP 797 Pharmaceutical Compounding – Sterile Preparations, the requirement of the frequency of environmental monitoring has been greatly reduced.
The chapter states that active air viable monitoring
is to be done at a minimum of every 6 months, as part
of the re-certification of facilities and equipment, after service of facilities and equipment and when problems
with end-products, staff technique or work practices are identified. Glove fingertip sampling shall be
done three times initially during evaluation of garbing and gloving competency with re-evaluation occurring
along with the annual or semi-annual media fills and surface sampling shall be performed periodically.
These stated frequencies are the very minimum
required. More frequent sampling will give a better
picture of microbial bioburden and allow for earlier detection of a problem or loss of control in the facility.
The data generated from air viable monitoring should be reviewed on a regular basis and used to identify a loss of environmental control and to locate and correct the problem. Surface sampling is a good way to evaluate the state of your facility, the effectiveness of your cleaning and disinfection program and the work practices of employees.
It is necessary to develop a sampling plan based on
the risk of the compounding activities being performed.
Choose sites in each ISO Class 5 environment and at nearby locations in the ISO Class 7 or 8 areas with the greatest risk of contamination. Agood sample plan must include the locations to be sampled, method
of collection, frequency of sampling, volume of air to be sampled, the time of day as related to activity and
the action level. Sampling must occur frequently enough to be useful and the data must be reviewed.
More information obtained about the
bioburden in the facility leads to a
better understanding of the overall state of control.
Laura A. Thoma, Pharm.D.
Laura A. Thoma, Pharm.D., is Professor of Pharmaceutical Sciences and Director of the Parenteral Medications Laboratories, University of Tennessee Health Science Center.
Dr. Thoma is
responsible for the
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