Lecture 1: sterile compounding Flashcards
Sterility definition
Complete absence of viable microorganisms
- can only be demonstrated by destructive testing for all compounded preparations
Compounded sterile preparations (CSP)
preparation intended to be sterile
created by combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering product/bulk drug substance
(USP 797)
What are some ways sterile preps may become contaminated?
Nonsterile ingredients
Process water
Packaging components
Process equipment
Compounding personnel
What is the purpose of sterile medications?
When route of admin bypasses the body’s natural defense mechanism s (parenteral)
Popular ROA for drug and vaccine administration
Subcutaneous
Intramuscular
Most common ROA for medications
Intravenous
Uncommon ROA for medication administration may obtain access for monitoring
Intraarterial
Common ROA for PPD and allergy test
Intradermal
ROA to inject into meninges of spinal cord
Intrathecal
ROA to inject into tissues surrounding spinal cord
Epidural
Other sterile routes of administration
Opthalamic (solution, susp, oint, inserts) + injections (intraocular/intravitreal)
Intranasal, inhalation
Some ointments (otic, vaginal)
Hand Hygiene
wash hands and forearms up to the elbows with soap + water before compounding
Things not to use in handwashing
No brushes
No hand dryers
Soap must be a closed system
Hand washing procedure
- remove visible debris from underneath fingernail under warm running water using a disposable nail cleaner
- wash hands and forearms up to the elbows w/ soap + water for at least 3 seconds
- dry hands and forearms to the elbows completely with low-lint disposable towels
Hand sanitizing
sanitize hands with alcohol based hand rub before donning sterile gloves
- must be donned in a classified room or segregated compounding area
Hand sanitizing procedure
enter segregated compounding area
1. apply alcohol to dry skin
2. rub hands together
3. allow hands to dry before donning gloves
Gloves
Sterile, powder free
apply 70% IPA regularly & whenever nonsterile surfaces are touched (vials, counter tops, carts)
Restricted access barrier system
Disposable gloves worn inside RABS glove and outside over the RABS
- Enclosure provides ISO class 5 air
- allows passage of materials through defined openings, generally not to be opened during operations
Garbing requirements
Use low lint gown, shoe covers, head cover, face mask
Sterile powder free gloves
Order of garbing must reduce the risk of contamination
Determined by facility, documented by SOPs
1. Donning/doffing in the ante-room
2. Replace if visibly soiled
3. may reuse within same shift if gown kept in classified area/SCA
Air quality standards: ISO class
air quality classification from the international organization for Standardization (ISO)
Classified based on particulate matter in room air
ISO class 5
Laminar airflow workbench
Cleanest
ISO class 7
Buffer room (cleanroom)
(352,000 particles)
ISO class 9
Ante-room
- for garbing
