Compounding I: basics

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what are the current versions of USP 795 and 797?
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Terms in this set (83)
what are the current versions of USP 795 and 797?
795: 2014

797: 2008
USP 795:

what are the categories based on complexity?
simple: following instructions

moderate: specialized calculations or procedures; no est stability data

complex: requires specialized training, equipment, procedures, etc
how big of particles are filtered by a HEPA filter?
>0.5 microns
what ISO rating must an ante room have?
ISO 8 if it opens to positive pressure

ISO 7 if it opens to negative pressure
what ISO rating must the SEC have?
at least ISO 7
when would a the HEPA filter be located at the top?
vertical airflow: BSC or C-PEC
how often should the HEPA filter be recertified?
every 6 months and anytime a PEC has been moved
what are the two types of compounding areas?
cleanroom: PEC inside SEC and entered through an ante room

segregated compounding area (SCA) with an ISO5 PEC: a sterile hood, often an isolator with a closed front
PECs for non hazardous sterile compounding?
HEPA filter air and positive pressure

LAFW or a CAI
where are CAIs typically located?
compounding aseptic isolators are often located in a SCA
what garb is required for compounding in a CAI?minimal hand hygiene and sterile, powder free gloveswhat are red waste buckets used for?sharps and non hazardous wastewhat is another name for a SEC?buffer room contains the PEC or multiple PEChow are shoe covers applied?one at a time while stepping over the demarcation linewhere does handwashing and donning of the gown occur within the anteroom?clean sidewhere are hair and face covers applied within the anteroom?dirty sideBUD of an emergency compounded CSP?1 hourBUD for a CSP made in an SCA?12 hourswhat type of air is in a SCA?unclassified airwho determined hazardous drugs?NIOSHa drugs is considered hazardous if what?carcinogenic teratogenic genotoxic toxic to organs at low doses labeled by the manufacturer with special handling instructionswhat does the SDS include?PPE, first aid procedures, spill clean up procedureswhat are yellow waste buckets used for?trace HD waste, such as empty vials and syringes PPE: gowns, gloves, masks, shoe coversdifference in "risk" in USP 797 vs 800797: risk of contamination of the sterile product 800: risk to the person compoundingwhat gloves are needed when counting or packaging HD?ASTM D6978 rated gloveshow could a pharmacy avoid having to follow USP800?for low risk activities: create AoR which limit staff exposurehow often are AoR documents reviewed?at least every 12 monthstypes of C-PECs for HD compounding?BSC (for sterile HD, has to be class II) CVEs: powder containment hoods (non sterile only) CACIs: glove boxeswhat C-PEC is used for non sterile HD compounding?CVEswhat are the requirements to compound sterile AND non sterile HD products in the same space?C-SEC must maintain ISO7 if there are separate C-PECs in the same C-SEC, must be kept 1 meter apartACPH: non sterile HD? sterile C-SEC? C-SCA?12 ACPH 30 12how could a pharmacy avoid external exhaust for HD?use redundant HEPA filters: non sterile only!!!what type of compounding requires external exhaust? redundant HEPA filters?HD compounding non sterile HD can use redundantHazardous drugs storage?stored separately from non HD negative pressure, 12 ACPHcompounding staff training?initial didactic training/hands on and continuous traininghow is aseptic technique in hand hygiene demonstrated? what about drug prep?gloved fingertip test media fill testGloved fingertip test: passing score is required initially and when thereafter?annually if only compounding low-med risk CSPs semi annually if HD compoundingGloved fingertip test: what agar is used?tryptic soy agar (TSA)Gloved fingertip test: passing initial test?requires 3 consecutive samples with zero CFUsGloved fingertip test: ongoing test?at least one sample from each hand after completion of media fill test, goal <3 CFUs for both handsMedia fill test: what is used to facilitate bacteria growth?tryptic soy broth (TSB)Media fill test: passing the test?if liquid stays clear after 14 days of incubationTemp monitoring: how often is SEC checked? what should the temp be?once daily 20C or 68FTemp monitoring: how often is fridge and freezer checked? what if it contains vaccines?daily twice daily if vaccinesTemp monitoring: what temp should the fridge be? freezer? what if vaccines are in freezer?2-8C fridge -25 to - 10C and -50 to -15C if vaccinesAir sampling: what does air sampling identify?contaminants in the airAir sampling: when should this be performed?every 6 months by a certified person or by a qualified compounding staff memberSurface sampling: USP testing requirements?periodicallySurface sampling: what is used to provide a good growth medium?TSASurface sampling: what is added to TSA? why?Polysorbate 80 and lecithin to neutralize the effect of any disinfecting agents on the surfacesSurface sampling: when should testing occur?end of the day when it is the dirtiestSurface sampling: results should indicate what?zero CFUsSurface sampling: when is action taken?>3 CFUs for ISO5 >5 CFUs for ISO7 >100 CFUs for ISO8how often should air pressure testing be done?once daily at least or with every shift changeEnvironmental parameters: monitoring frequency Air sampling? Surface sampling? Air pressure? Humidity?Air: at least every 6 months Surface: periodically Pressure: each shift or daily dailywhat should the humidity set at?<60%when should the PEC be turned off?NEVER!!!what should happen if the PEC is turned off?clean: germicidal detergent and then disinfect with 70%IPA then must be on for 30 minutes before compounding again **if it is C-PEC then sanitization needs to happencan spray bottles be used to clean PEC?yes but do not spray inside PECwhat direction are PECs cleaned?top to bottom, front to back unidirectional strokes, slightly overlappinghow often are counters, floors and carts cleaned?dailywhat is cleaned monthly? (6)ceiling walls shelves chairs bins cartswhen are ISO5 PECs cleaned?before each shift every 30 min while working before and after each batch of CSPs whenever needed, including spillswhat is the black waste used for?bulk HD waste: any containers with visible drug, supplies used to admin HD or to clean up HD spillsHD cleaning specifics: process for cleaning HD equipment?deactivate and decontaminate clean disinfectHD cleaning specifics: what products are used in each step of cleaning?bleach or peroxide germicidal detergent: Quat, ammonium, phenolics 70%IPAhow long should some wash if they had eye exposure?at least 15 minutesHD: respiratory protection what should a staff member do if HDs are unpacked and they a not contained in plastic?wear an elastometric half mask, with a multi gas cartridge and P100 filterHD: respiratory protection what type of mask is sufficient for most HD compounding?N95HD: respiratory protection what should be worn if there is a risk of respiratory exposure?fit tested respirator mask with attached gas canisters powered air purifying respirator (PAPR)what should be consulted when a HD spills?SDSwhat needs to be worn when administering HD?two pairs of chemo gloves gown is required when admin IV HDswhat should be used by nurses for HD drug admin?CSTDswhat are chemotherapy pins used for?prevent HDs from aerosolizingwhat needs to be done if a nurse needs to crush a HD?crush in plastic bagHD: disposal outer chemo gloves disposed where?yellow binHD: disposal where are gown and outer shoe covers taken off and disposed of?must be taken off before exiting the negative pressure area and thrown in yellow binwhen can single gloves be used in HD compounding?only when receiving and storagenon sterile HD PPE?double gloves, gown, mask and a disposable pad to protect work surfacesterile HD PPE?head covers, face masks two pairs shoe covers gown impermeable to liquids two pairs of chemo gloves a full face piece respirator or a face shield with goggleshow should gloves be worn in HD compounding?one pair tucked under cuffs and second pair goes over the cuffwhat material gown is best for HD compounding?impermeable: polyethylene-coated polypropylene or other laminate materialhow often is the gown changed in HD compounding?every 2-3 hours or immediately after spills or splash