International Journal of Pharmaceutical Compounding

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Basics of Sterile Compounding: Personnel Requirements for Sterile Compounding

Author(s): Akers Michael J

Issue: Jul/Aug 2016 - Volume 20, Number 4
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Page(s): 307-314

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Abstract: The risk of microbial contamination during sterile product preparation would be practically non-existent were people not involved in the preparatory process. This article discusses why people are the main source of microbial contamination and what safeguards need to be present to minimize this source.

Related Keywords: Michael J. Akers, PhD, compounded sterile products, aseptic compounding, microbial contamination, cleanroom, particle standards, good manufacturing practice, GMP, personal hygiene, skin colonization, gowning, personnel training, personnel evaluation, broth test, media fill, drug safety

Related Categories: BUSINESS, ENVIRONMENTAL , LEGAL, STERILE PREPARATIONS, SUPPORT, QUALITY CONTROL

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