Lecture Flashcards
(25 cards)
What is the definition of compounded sterile product?
a sterile drug or nutrient prepared in a licensed pharmacy or other healthcare-related facility pursuant to the order of the licensed prescriber
To which entities does USP 797 apply?
institutions, pharmacies, and facilities that prepare, store, and dispense CSP’s
Which USP chapters are enforcable?
all < 1000
What is the purpose of USP Chapter 797?
prevent harm and increase regulation coverage
What are the 5 possible risk categories of CSPs?
immediate use, low w/ 12h BUD, low, medium, hi
What types of CSPs fall into the immediate use category exemption?
intended for emegency and used within 1 hour; normally low-risk
What are environment requirements for risk levels?
ISO Class 7 cleanroom w/ ante area; ISO Class 5 LAFW
What CSPs fall into low-risk category?
simple transfers & reconstitutions; no more than 3 sterile products and 2 entries
What CSPs receive the low-risk w/ 12h BUD classification?
LAFW not in ISO Class 7 cleanroom; low-risk products only
What CSPs receive medium risk level?
multiple additives or small volumes or long duration of prep; batching
What CSPs receive high-risk level?
nonsterile ingredients or improper garbing or anything sterile and non-preserved exposed to < ISO 5 air for > 1 hour
What is the definition of BUD?
date or time after which CSPs should not be stored or transported
Low level BUDs:
48h @ RT, 14d fridge, 45d freezer
Medium level BUDs:
30h @ RT, 9d fridge, 45d freezer
High level BUDs:
24h @ RT, 3d fridge, 45d freezer
Describe handwashing procedure.
Scrub to the elbow with appropriate cleanser for > 30s
What is contained in the buffer zone?
hood, cart, (counter?)
what does HEPA stand for?
high-efficiency particulate air (HEPA) filter
what is the critical site?
the area between HEPA & CSP
what is the zone of turbulence?
turbulent air created by any object interrupting first air to the critical site
how large is the zone of turbulence?
3x the diameter of the interfering object
How often is a hood certified?
every 6 months
What are the 2 most critical aspects of aseptic technique?
proper handwashing & proper syringe/needle manipulation
what are the components of the needle
shaft and hub
