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PP&P Compounding & Cleanrooms 2006
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White Paper on Isolator Compliance The Baker Company recently concluded testing on their compounding aseptic isolators (CAIs) and compounding aseptic containment isolators (CACIs) to demonstrate compliance with the proposed USP <797> changes, which include a requirement for manufacturers to demonstrate that their CAIs and CACIs maintain ISO Class 5 internal cleanliness while located in an environment worse than ISO Class 7. Baker has prepared a white paper detailing the experimental process used to demonstrate compliance for its SterilSHIELD CAI and ChemoSHIELD CACI.
CLICK HERE to download the PDF of this full article (Adobe Acrobat™ 6.0+ required)
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PP&P Compounding & Cleanrooms 2006
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By Eden M. Venti, ASQ CQA
Facilities that prepare, store, and dispense compounded sterile preparations (CSPs) are responsible for ensuring continued compliance with USP Chapter <797> through a series of in-process and finished-process quality checks. Appropriate quality checks will ensure preparations are consistently compounded correctly. In addition, risk assessments should be performed prior to the release of a medication. Risk assessments will ensure that all of the variables (materials, people, environment, methods, intended use, etc.) surrounding the preparation, in addition to performed and recorded quality checks, are taken into consideration prior to the finished preparation’s release.
CLICK HERE to download the PDF of this full article (Adobe Acrobat™ 6.0+ required)
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Making Sense of Engineering Controls: The Proposed Changes to USP Chapter |
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PP&P Compounding & Cleanrooms 2006
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By Carl J. LaBella, BS, MBA
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Understanding the Microbiology Behind USP |
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PP&P Compounding & Cleanrooms 2006
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By Alice S. Weissfeld, PhD (ABMM), F(AAM), and Paula H. Vance, SM(NRM), SM(ASCP), CLS(M)
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So What Have You Done Today to Improve Patient Safety? |
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PP&P Compounding & Cleanrooms 2006
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By Eric S. Kastango, MBA, RPh, FASHP
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Read more...
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