Notes in Gurrero L01 USP-797

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Published	10/11/2023	USP<797> Sterile Compounding (Slide 2)Definition: “{{c1::combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise alter…
Published	10/11/2023	USP <797> Pharmaceutical Compounding Sterile Preparations (Slide 3)USP <797> sets standards for {{c1::sterile}} compoundingEnforced by {{c…
Published	10/11/2023	USP<797> Standards (Slide 4) Goal is to {{c1::minimize}} harm, including death to human and animal patients that could result from:{{c1::Microbi…
Published	10/11/2023	USP <797> Terminology (Slide 5)USP ({{c1::United States Pharmacopeia}})PEC ({{c1::Primary Engineering Control}})SEC ({{c1::Secondary Engineering…
Published	10/11/2023	Compounded Sterile Preparations (Slide 6) (6){{c1::Injectable productsIrrigations for internal body cavities (e.g. bladder, peritoneal cavity)Ophthalm…
Published	10/11/2023	Immediate Use CSPs (Slide 7)Administration to begin within {{c1::4 hours of preparation}}Do not need to comply with {{c1::Category 1 or Category 2}} r…
Published	10/11/2023	Immediate Use CSPs (Slide 8){{c1::Physical}} and {{c1::chemical}} compatibility recommendations followed{{c1::Single}} dose vials used for {{c1::one}}…
Published	10/11/2023	Sterile Preparation Categories (Slide 9)Category 1BUD less than or equal to {{c1::12 hours at room temp}} or BUD less than or equal to {{c1::24 h…
Published	10/11/2023	Sterile Preparation Categories (Slide 9)Category 2BUD less than or equal to {{c1::12 hours at room temp}} or BUD less than or equal to {{c1::24 h…
Published	10/11/2023	Category 3* (Slide 10)*Set to become official {{c1::November 2023}}May be assigned {{c1::longer BUDs}} than limits for Category 1 or 2, up to {{c1::18…
Published	10/11/2023	{{c1::ISO Classification of Particulate Matter in Room Air}} (Slide 11) NOT NEEDED TO KNOW JUST KNOW THE REQUIRED ISO CLASS FOR EACH PREPARATION CATEG…
Published	10/11/2023	Qualifications for Sterile Compounding (Slide 12)Must complete training {{c1::initially}} and every {{c1::12}} monthsWritten or electronic testing eve…
Published	10/11/2023	Sterile Compounding Competency (Slide 13){{c1::Hand hygieneGarbingCleaning and disinfectionCalculations, measuring, and mixing}}{{c2::Aseptic techniqu…
Published	10/11/2023	Sterile Compounding Competency (Slide 14)Must document proper {{c1::handwashing technique}} and {{c1::garbing}}, initially* and every {{c1::6}} months…
Published	10/11/2023	Personal Hygiene (Slide 15)Most microorganisms detected in cleanrooms come from {{c1::humans}}Skin cells shed from humans at a rate of {{c1::10,000,00…
Published	10/11/2023	Personal Hygiene (Slide 16){{c1::Remove outer garmentsRemove makeupNo nail polish, no artificial nailsKeep nails neat and trimmed}}{{c2::Remove jewelr…
Published	10/11/2023	Handwashing Technique – USP <797> (Slide 17)Remove visible debris from {{c1::underneath fingernails}} under warm running water using a {{c1::dis…
Published	10/11/2023	Hand Sanitizing – USP <797> (Slide 18)Apply an {{c1::alcohol-based hand rub}} to dry skin following the manufacturer’s instructions for the volu…
Published	10/11/2023	Garb Items (Slide 19){{c1::Low lint gown}} or {{c1::coveralls}} with sleeves {{c1::snug around the wrists}} and enclosed at {{c1::neck}}{{c1::Low-lint…
Published	10/11/2023	Sample Garbing Procedure (Slide 20)Perform garbing in following order On {{c1::dirty side}} of ante room {{c1::Shoe}} covers{{c1::Head and f…
Published	10/11/2023	Media-Fill Challenge Testing (Aseptic Technique Validation)  (Slide 21)“Test used to qualify {{c1::aseptic}} technique of compounding personnel o…
Published	10/11/2023	Compounding Facilities (Slide 26)Sterile compounding facilities must be {{c1::designed, outfitted}}, and {{c1::maintained}} properly to {{c1::minimize…
Published	10/11/2023	Engineering Controls (Slide 27) Most likely a test questionPrimary Engineering ControlsA {{c1::device or zone}} that provides an {{c1::ISO Class 5 a…
Published	10/11/2023	Air Quality Requirements (Slide 29) Most likely a test questionAnte-room minimumISO Class {{c1::8}} (if have positive pressure buffer room)ISO Class…
Published	10/11/2023	Other Cleanroom Suite Requirements (Slide 32)Temperature {{c1::20 degrees}} CelsiusHumidity {{c1::<60%}}{{c1::Pressure differential}} monitoring sy…
Published	10/11/2023	Segregated Compounding Area (SCA) (Slide 34){{c1::Unclassified}} area, without an {{c1::ante-room}} or {{c1::buffer room}}Only {{c1::Category 1 CSPs}}…
Published	10/11/2023	Primary Engineering Controls (Slide 35)LAFW ({{c1::Laminar Airflow Workbench}})BSC ({{c1::Biological Safety Cabinet}})CAI ({{c1::Compounding Aseptic I…
Published	10/11/2023	Laminar Airflow Systems (Slide 36)Systems that provides {{c1::ISO Class 5 or better}} conditions{{c1::Unidirectional}} airflow, either {{c1::horizonta…
Published	10/11/2023	Working in a Laminar Airflow Workbench (Slide 39)Horizontal LAFWMaintain a direct, open path between the {{c1::HEPA filter}} and the {{c1::area inside…
Published	10/11/2023	Working in a Laminar Airflow Workbench (Slide 42)Vertical LAFWPlace larger containers toward the {{c1::back of the work area}}Do not {{c1::block the a…
Published	10/11/2023	Other Requirements (Slide 44)Items must be wiped down with {{c1::sporicidal agent, disinfectant, or sterile 70% IPA}} before entering {{c1::cleanroom …
Published	10/11/2023	Master Formulation Record for Compounded Sterile Products (Slide 46){{c1::Name, strength, and dosage form}}{{c1::Ingredients and amounts of each}}{{c1…
Published	10/11/2023	Compounding Record for Compounded Sterile Products (Slide 47){{c1::Name, strength, and dosage form}}{{c1::Date and time}} of preparation{{c1::Internal…
Published	10/11/2023	Labeling (Slide 48)Assigned {{c1::Internal ID}} number (e.g. prescription #){{c1::Active ingredients}} and {{c1::amounts}}, or {{c1::concentrations}}{…
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