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Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance

Author(s):  Grilli Anthony, Sutton Scott

Issue:  Jan/Feb 2015 - Volume 19, Number 1
View All Articles in Issue

Page(s):  30-37

Note:  Electronic version includes supplemental material.

Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance Page 1
Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance Page 2
Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance Page 3
Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance Page 4
Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance Page 5
Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance Page 6
Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance Page 7
Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance Page 8

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Abstract:  This article provides the results of a study evaluating the sampling efficiency of a flat paddle sampling device against a round surface sampling device in controlled studies. Each device is supplied with identical microbial-growth media, and laboratory studies document equivalent performance of the media in the devices. Both devices perform sampling by the same process (agar transfer of microorganisms from the facility surface to the agar surface), and the performance of the two devices was shown to be equivalent in laboratory studies. Either the commonly used flat paddle sampler or the round contact plate is suitable for surface monitoring in the compounding pharmacy.

Related Keywords: Anthony Grilli, MS, Scott Sutton, MS, PhD, agar transfer devices, environmental sampling, pharmacy environment, cleanroom environment, microbial monitoring, bacterial contaminants, bacteria, microbe recovery, environmental monitoring program, aseptic processing, U.S. Food and Drug Administration, FDA inspection, United States Pharmacopeia, compounded sterile preparations, contact places, flat paddle samplers

Related Categories: ENVIRONMENTAL , LEGAL, SUPPORT, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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