Week 1 Flashcards
What is sterility?
A complete absence of viable microorganisms
What is aseptic technique?
The methods and manipulations required to minimize the contamination of sterile compounded formulations
Routes of administration that require sterile preparation
Intravenous (IV)
Intramuscular (IM)
Subcutaneous (SC,SQ,SubQ)
Intrathecal(IT)
Epidural
Intradermal
Ophthalmic (solutions,suspensions,ointments,inserts)
Irrigations
Intra-articular(into the joint)
Pulmonary inhalations
Intravenous (IV)
Injection into the venous system
Intramuscular (IM)
Injection into the muscle tissue
Subcutaneous (SC,SQ,SubQ)
Injection beneath the skin
Intrathecal(IT)
Injection into the meninges of the spinal cord
Intradermal(ID)
Injection within the skin
What is sterility compounding ?
Requires strict processes and procedures to avoid contamination.
Sterile compounds must be free of microorganisms (bacteria,viruses,fungi) as well as contaminants (glass shards,precipitate,particulate matter)
Points in the preparation of CSPs where contamination can occur
Non-sterile ingredients
Packaging components
Process equipment
Compounding personnel
Scope of USP 797
Infusions,injection,aqueous preparations for pulmonary inhalations, irrigations for internal body cavities, ophtalmics(including drops), implants, bath and soaks for live organs and tissues
Air Qulaity Standards
Lower particle count= cleaner air
- ISO Class 5-3520 particle count/m3
- ISO Class 7-352,000 particle count/m3
- ISO Class 8- 3,520,000 particle count/m3
Primary Engineering Controls(PECs)
A device or zone that provides an ISO class 5 air quality environment for sterile compounding
Laminar Airflow Workbench , isolator
aka “hood”
Secondary Engineering Control (SEC)
The area where the PEC is placed; incorporates specific design and operational parameters required to minized risk of contamination within the compounding area
The clean room
The room in which the hood is place
Laminar Air Flow Workbench (LAFW)
Horizontal LAFW
- Filtered air flows horizontally towards the compounder from a HEPA filter located at the back of the hood
- Most common LAF hood for non-hazardous sterile compounding
Laminar Air Flow Workbench(LAFW)
Vertical LAFW
- Biological safety cabinet
- Filtered air flows top to bottoms
- Used for hazardous medication preparation
- Protects the compounder
Hand hygiene
Wash hands and forearms up to the elbows with soap and water initiating compound activities(at least 30 seconds)
No brushes, no hand dryers, closed system of soap
Hands sanitized with alcohol-based hand rub prior to donning sterile gloves
What are garbing requirments?
- Low-lint garment with sleeves that fit snuggly around the wrists and an enclosed neck
- Low-lint covers for shoes
- Low-lint cover head that covers the hair and ears and if applicable facial hair
- Low-lint face mask
- Sterile powder free gloves
How to clean the hood?
- Top, using side to side motion from inside out
- Hanging pole using gripping motion
- Sides, using top to bottom from inside out
- Bottom, using side to side motion from inside out
Frequency in cleaning the hood
- Before each shift
- Every 30 mins while working
- Before/after each batch
- Whenever visibly soiled
Aseptic Technique when working within a sterile hood
- Wipe off outside of all materials with 70% IPA before bringing them into the hood
- Always work at least six inches into the hood
- Dont rip open components, open at defined seals within the hood
- Place items in the hood side-by-side, with all critical points facing into first air
- Do not obstruct first air with hands or supplies
- No item should be between steriles oject and HEPA filter in a horizontal LAFW or above a sterile object in a vertical LAFW
- Do not let garbage accumulate within the hood
