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cleaning of sterile compounding environments
-logs are required for these cleanings to ensure compliance
-if items are in hazardous compounding area, the cleaning agent must also have deactivating activity
cleaning agent properties
-cleaning agents will be specific to the facility
-need to be approved by infection control
-products are selected based on:
->contact time
->spectrum of coverage
->active ingredient
->safety to personnel and equipment
->residue
->EPA registration
->available in sterile form: cleaning of PEC must be done w/ sterile items only
->trends of growth in environment
cleaning
-an agent, usually containing a surfactant used for the removal of substances (dirt, debris, microbes, residual drugs or chemicals) from surfaces
disinfectant
-chemical or physical agent used on inanimate surfaces and objects to destroy fungi, viruses, bacteria
sporicidal
-chemical or physical agent that destroys bacterial and fungal spores when used at a sufficient concentration for a specified contact time
-expected to kill all vegetative microorganisms
cleaning agents
-sterile water: breaks up contamination
-sterile 70% IPA: disinfects bacteria
->double bag packaging means bottle is sterile
->open first bag when bringing across line of demarcation and then second bag once in hood (stays in hood)
-germicidal agent: disinfects w/ wider coverage of bacteria
-sporicidal agent: mold and fungal converge
cleaning agent sterility
-cleaning, disinfecting, and sporicidal agents used within the PEC as well as supplies must be sterile
-cannot put body/exposed skin inside hood to reach far spaces: obtain a mop head/wand
->must be cleaned and disinfected before and after each use
->reusable cleaning tools must be dedicated for use in classified areas
-once opened, sterile cleaning and disinfecting agents and supplies and sterile 70% IPA may be reused for a time period specified by the manufacturer
-eliminate spray bottles as they are not permitted for use in the PEC
basic cleaning principles
-work from cleanest to dirtiest and top to bottom to prevent introduction of contamination during cleaning process
-turn lint-free wipe to clean surface frequently
->to reduce spread of contamination and inc effectiveness
->must be lint free
-work in one direction using linear overlapping strokes
->to ensure thorough and complete coverage
-entire surface must be wetted w/ cleaning agent
->to facilitate removal of dirt and particles and chemical contact w/ surface
-tools such as mops, wands, etc must be non-shedding, dedicated, and disposable
cleaning of controlled environment
-everything in controlled environment beyond line of demarcation must be cleaned
-use detailed cleaning logs: where to clean, what to use, contact time, when to clean
-particle generating items are not permitted in controlled environment
->brown cardboard is not only high particle generating, but carries bacteria and spores
->shelving prone to dust and external box of medications contaminate storage areas (anything w/ 90 degree angle)
-special attention to high touch areas, ex incl: handles of doors, cart hand rails, drawer hand grip, computer keyboards or touchscreens, refrigerator door handles, accessories for compounding/IV tech
cleaning of items for compounding
-wrappers of packing and boxes for med vials are very dirty
->cause of contamination and particle production
->cardboard boxes are not permitted anywhere in the clean room
-all items are wiped TWICE before item is used for aseptic technique
-1. all items must be wipes w/ sporicidal disinfectant, disinfectant, or sterile 70% IPA when being brough into the controlled environment for storage (all items must be wiped down when crossing the line of demarcation)
2. all items must be wiped w/ disinfectant agent (sterile IPA) when being brought into compounding hood
cleaning compounding hoods
-goal is to drag contamination out of hood
-all cleaning agents must be sterile and remain in the hood
-use sterile, lint-free or low lint cloths to clean the hood
-full compounding garb is required when performing cleaning activities
-be careful on the light and HEPA filter
-use of spray applicator is not permitted directly into hood: pre-saturated wipes or apply cleaning agent to wipe to apply the cleaning agent to the compounding hood
-you cannot have your body inside the hood -> no exposed skin can be present
-USP says to disinfect at least every 30 minutes
->best practice: disinfect work surface of the hood before and after each manipulation
-reminder: items that are 1) not sterile or 2) have not been sterilized cannot be placed inside the compounding hood
folding the lint free towel
-fold the lint free paper towel in half and then half again (fold twice)
-must use a clean part of the towel w/ each new surface or the hood
->minimizes contaminating other areas of the hood
cleaning Laminar (horizontal) flow hood
Cleaning the LAFW at the beginning of each shift:
1. collect lint/ free wipes and disinfectant
2. adequately saturate wipe w/ disinfectant and wipe all interior surfaces on LAFW
->order: ceiling ->back wall -> rod -> sides -> bottom
3. ceiling (be careful of light); direction left to right and back to front
4. back of hood/HEPA filter grate: direction left to right and top to bottom
5. bar and hooks (incl cups bar sits in)
6. side of hood: direction up and down, back to front
7. any items on the work surface area/deck (remove to clean work surface area/deck in step 8)
8. work surface area/deck: direction moving side to side, back to front
9. collect lint free wipes and sterile water for injection (SWFI)
10. adequately saturate the wipe w/ SWFI and wipe all interior surfaces on the LAFW in the order of steps 3 to 8
cleaning the hoods
1. ceiling
2. back wall (HEPA grate): top to bottom, side to side
3. rod and hooks
4. sides: back to front, up and down
5. bottom
cleaning compounding aseptic isolator
1. get wipe
2. saturate wipe and wipe in correct order
-ceiling -> back of hood -> bar and hooks -> sides of hood -> inside surface of glass view screen -> work surface area/deck -> gauntlet gloves (while arms inside, wipe out of gloves)
3. collect lint free wipes and sterile water for injections (SWFI)
4. adequately saturate the wipe w/ SWFI and wipe all interior surfaces on the CAI in teh order of steps 3-10
5. adequately saturate the wipe w/ disinfectant and wipe all interior surfaces of antechamber allowing rec contact time
6. adequately saturate wipe w/ IPA and wipe all surfaces
-do not forget to clean the pass through on each shift!!
additional requirements for compounding aseptic isolators
-each shift gloves and sleeves need to be inspected and cleaned
-when detailed cleaning w/ bleach/sporicidal agent is done, isolator must be turned off when opened
->must run for 30 min before resuming compounding activities
-an isolator mini mop can be used to each difficult places
-compounding garb must be worn when cleaning isolator
cleaning biological safety cabinet
1. get wipe and deactivating agent
2. saturate wipe and wipe in correct order
-ceiling/HEPA filter -> back of hood -> bar and hooks -> sides ->inside surface of glass view screen -> work surface area/deck
3. adequately wipe all interior surface in BSC w/ IPA in same order