USP 797 Flashcards
What does USP stand for?
United States pharmacopeia
USP established
standards for the identity, strength, quality & purity of medicines, food ingredients & dietary supplements
USP is enforced by who in the us?
FDA
chapter 797 first version
- January 1, 2004
- procedures & requirements for compounding sterile products
- sets standards that are applicable to all places that prepare sterile products
Chapter 797 revision
- june 1, 2008
- mostly the same contents but additions & clarifications
purpose of 797
- protect the health of patients by reducing the potential for microbial contamination caused by an unclean environment , excessive bacterial endotoxins, larger errors in strength of ingredients & use of incorrect ingredients
acceditation
the joint commision (TJC), DNV & other accrediting orgs use USP standards for the certification requirements
what is included in 797
garbing requirements hand washing room requirements training cleaning testing of the environment
what does ISO stand for?
international organization of standardization
what does ISO do?
ensure that products & services are safe, reliable & of good quality
- used for electronics, IT, engineering, agriculture, etc
ISO 3 particle count
35.2/m^3
~1/ft^3
ISO 4 particle count
352/m^3
~10/ft^3
ISO 5 particle count
3520/m^3
~100/ft^3
ISO 6 particle count
35,200/m^3
~1000/ft^3
ISO 7 particle count
352,000/m^3
~10,000/ft^3
ISO 8 particle count
3,520,000/m^3
~100,000/ft^3
ISO 9 particle count
35,200,000/m^3
~1,000,000/ft^3
examples of particles
oil, metal shavings, dust, smoke, ash, mold, ect
origination of particles
garments, paper, pencils, cosmetics, skin, nail polish, hair, oral secretions
everyday particle count of hospital surgery suite
~50,000/ft^3
everyday particle count of outdoor air
~200,000-2,000.000/ft^3
everyday particle count of indoor air
2 million-10 million/ft^3
particle produced by a motionless person
~100,000 particles/minute
particles produced by a walking person
~5,000,000 particles/min
particles produced by a garbing person
~3,000,000 particles/min
ISO class 5
laminar airflow workbench (LAFW), biological safety cabinet (BSC), compounding aseptic containment isolator (CACI), compounding aseptic isolator (CAI)
ISO 7
buffer room or ante if connected to chemo room
- room the hoods are in
ISO 8
- ante area- , UNLESS connected to chemo room (ISO 7)
- where you wash your hands & garb
- clean supplies
ISO 7 should not have
sinks, floor drains, outer doors, opening windows
what class are hoods
ISO 5
what kind of pressure should bugger area have?
POSITIVE pressure unless it is a chemo buffer room, then NEGATIVE pressure
what do you see in the hood
easily cleanable surface minimal supplies light/UV light pole with hooks electric plug filter
risk level is assigned according to
the probability of contaminating a compounded parenteral with:
- microbial contaminants
- physical & chemical contaminants
low risk
<8
- annual testing
low risk BUD
Max 48 hours RT
max 14 days refrigerated
max 45 days frozen
low risk </+ 12 hour BUD
- administration must start no later than 12 hours after preparation
- must be made in ISO 5
medium risk
> 3 sterile products
2 entries/product
- must be ISO 5<8
- annual testing
medium risk BUD
max 30 hours RT
max 9 days refrigerated
max 45 days frozen
high risk
- non-sterile products or equipment
- must be 5<8
- semi annual testing
high risk BUD
max 24 hour RT
max 3 days refrigerated
max 45 days frozen
immediate use
- nonhazardous meds
</= 2 entries/product - administered w/in 1 hour
- no label if prep & admin by same person
immediate use BUD
max 1 hour RT or refrigerated
single dose BUD
1 hour if worse than ISO 5 (immediate use)
6 hours if ISO 5
ampules shouldnt be stored
BUD multiple dose containers
28 days
hazardous drugs
chemo or any IV drug that may put the compounder at risk
hazardous drugs must be stored
- separate from other inventory
- storage area should be well ventilated with at least 12 air changers per hour (ACPH)
where must hazardous drugs be compounded?
ISO 5 biological safety cabinet or compounding aseptic containment isolator
for hazardous drugs, must have what buffer room?
ISO class 7 buffer area with no less than 0.01inch water column NEGATIVE pressure & separate from other preparation areas. - must have ISO 7 ante area with POSITIVE pressure
personnel compounding hazardous drugs must be trained & annually tested in:
safe aseptic manipulation
negative pressure when using BSC or CACI
correct use of CSTDs
containment, cleanup & disposal for spills & breakages
treatment of personnel contact & inhalation
what does HEPA stand for
high efficiency particulate air
facility requirements
well-lit
20C (68C) or cooler
buffer area not physically separated from ante areas
smooth & cleanable surfaces
environment air sampling must be done
every 6 months
nonviable air sampling
- do not contain living organisms
- designed to directly measure performance of the 1* & 2* engineering controls
- Q 6 months
viable air sampling
- include PEC, buffer area & ante area & areas prone to contamination (entryway, pass-through boxes)
- sample DURING entire compounding process
pressure between buffer & ante area
- 02-0.05 in water column with physical separation
- min velocity of 0.2m/s (40ft/min) w/out separation
pressure between ante area & general non-compounding area
no less than 5Pa (0.02in water column)
