Week 3 Flashcards
Define US Pharmacopeia
Established standards for the identity, strength, quality and purity of meds, food ingredients and dietary supplements
Who enforces the US Pharmacopeia?
FDA
Define Chapter 797
Compounding sterile products
= Set standards that are applicable to all places that prepare sterile products
Purpose of the 797
To protect the health of pts by reducing contamination possibilities
States indirect mean:
Do not specifically site USP 797 but there are laws and regulation for sterile compounding
797 includes:
Garbing requirements Hand washing Room requirements Training Cleaning Testing of the environment
Define International Organization of Standardization (ISO)
Ensure that products and services are safe, reliable and of good quality
ISO 5 Particle limit
3520
~100 ft^3
ISO 7 Particle Limit
352000
~10000 ft^3
ISO 8 Particle Limit
3,520,000
~ 100,000 ft^3
ISO Class 5 is required where?
LAFW, biological safety cabinet, compounding aseptic containment isolator, compounding aseptic isolator
HEP filtered unidirectional airflow
Hoods
ISO Class 7 is required where?
Buffer room
Hood room
ISO Class 7 is required where?
Ante area
Where you waash your hands and put on PPE
Clean supplies
What do you see in the Ante area?
Sink
Supplies
Hand dryer/paper towels
What do you do in the Ante area?
Wash hands and put on garb
Open and clean supplies
What do you see in buffer area?
Smooth and continuous surfaces
No sinks, drains, outer doors, opening windows
Hoods, minimal supplies and pumps
Control of humidity, temperature, pressure
Buffer areas should have _____ pressure which ___________.
Positive; pushes air out of the room
Unless ___________ then it has to have negative pressure.
Chemo buffer room
What do you do in the buffer area?
Prepare for compounding
What do you see in the Hood?
Easily cleanable surfaces Minimal supplies Light/UV light Pole with hooks Electric plugs Filter
What do you do in the hood?
Compound
Risk level is assigned according to the probability of contaminating a compounded with:
Microbial contaminants
Physical and chemical contaminants
Low Risk Max Room Temp
48 hours
Low Risk Max Refrigerated
14 days
Low Risk Max Frozen
45 days
Low risk requirements
ISO class 5 within an ISO class 7 with an ISO class 8 ante area
<2 entries
Annual media fill test
Low Risk </= 12 hours Requirement
ISO Class 5 Nonhazardous Admin is no later than 12 hours after Segregated compounding area Cleansing and garb required
Medium Risk room temp
30 hours
Medium Risk refrigerated
9 days
Medium Risk frozen
45 days
Medium Risk Requirements
> 3 sterile products
2 entries
Annual Media Fill-Test
High Risk Requirements
Nonsterile
Biannual Media Fill Test
High Risk room temp
24 hrs
High risk refrigerated
3 days
High risk frozen
45 days
Immediate use requirements
<1 hr after making
Single dose BUD
1 hr if not in hood
6 hr if in hood
Multiple-dose containers BUD
28 days
Define Hazardous Drug
Chemo or any IV drug that may put the compounding personnel at risk
Stored separate in well ventilated area (12 air changes per hour)
Hazardous Drugs Buffer area vs ante
ISO class 7 with negative pressure ISO class 8 with positive pressure
Personnel must be trained in
Safe aspetic manipulation
Negative pressure techniques
Correct use of closed system vial transfer device
Containment, cleanup and disposal for spills and breakage
Treatment of personnel contact and inhalation
Re-certification of facilities and equipment and nonviable air sampling occurs?
Every 6 months
Must also do
Viable air sampling and have a pressure gauge
