Summary of USP* – Pharmaceutical Compounding – Sterile Preparations. Source of base information – Pharmacopeial Form – Vol 29 (4) July – Aug. USP is a far-reaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations are prepared, stored, and dispensed. Below is a summary of the USP regulation. The USP published its second proposed revision to > Pharmaceutical Compounding — Sterile Preparations. Significant input from.
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Summary of USP for Compounding Sterile Preparations | EES, Inc.
The confusing language from the current chapter has been clarified to state that plates which exceed action level should be identified to genus with the assistance of a microbiologist. FOCUS microbiologists perform microbial identifications by either usp 797 summary or biochemical profiling, always resulting in at least a genus ID.
Recommends a single media and the following incubation times for air and surface sampling: This is a change from the previous suggestion of of Malt Extract Agar.
There are advantages and disadvantages to this approach. An advantage is saving on usp 797 summary cost of a specialized fungal media. A disadvantage is the enhanced ability of MEA to actually culture wild mold versus TSA we have data demonstrating thisand a lengthened incubation period before you can react to Action Levels.
The guideline requires environmental controls to include a separate area for compounding that meets a definite level of cleanliness, and monitoring usp 797 summary guarantee that control is maintained.
While the Board cannot definitely usp 797 summary that pharmacists will face disciplinary action for the failure to follow USPthe possibility does exist.
It is under review by numerous others. States have the usp 797 summary to implement exactly or to edit the standards into pharmacy regulations. The risk level depends on the CSPs compounding environment; its potential for microbial, chemical, and physical contamination; the nature of production of the CSP.
It is the usp 797 summary of personnel to determine the correct level. Dissolving non-sterile bulk drug and nutrient powders to make solution, which will be terminally sterilized. Sterile ingredients, components, devices, and mixtures are exposed to air quality inferior to ISO Class 5.
This includes storage in environment inferior to ISO Class 5 of opened or partially used packaged of usp 797 summary sterile products that lack antimicrobial preservatives. Measuring and mixing sterile ingredients in non-sterile devices before sterilization is preformed.
Personnel Training and Evaluation in Aseptic Manipulations Usp 797 summary Personnel who prepare compounded sterile products must be provided with appropriate training from expert personnel, audio-video instructional sources, or professional sour-ces before beginning to prepare products.
Personnel shall perform didactic review, writ-ten testing, media fill testing or aseptic manipulative shills usp 797 summary and at least annually for low and medium risk levels and semi annually for high risk level compounding.
Media fill challenge testing will be used to access the quality of aseptic skills. Clean Rooms Must have an ante area but need not be separated with a physical wall.
- USP Clean Room Guidelines | Standards for Sterile Compounding Labs
- An Overview of USP
usp 797 summary Positive pressure to adjacent areas per ISO Physical characteristics of construction: Walls, floors, fixtures and ceilings should be smooth, impervious and free of cracks, crevices and non-shedding.
Surfaces should be resistant to damage from sanitizing agents. Junctures of ceilings to walls should be coved and caulked.