USP 797

Question 1

What does USP stand for?

Answer 1

United States pharmacopeia

Question 2

USP established

Answer 2

standards for the identity, strength, quality & purity of medicines, food ingredients & dietary supplements

Question 3

USP is enforced by who in the us?

Answer 3

FDA

Question 4

chapter 797 first version

Answer 4

• January 1, 2004
• procedures & requirements for compounding sterile products
• sets standards that are applicable to all places that prepare sterile products

Question 5

Chapter 797 revision

Answer 5

• june 1, 2008

- mostly the same contents but additions & clarifications

Question 6

purpose of 797

Answer 6

• 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

Question 7

acceditation

Answer 7

the joint commision (TJC), DNV & other accrediting orgs use USP standards for the certification requirements

Question 8

what is included in 797

Answer 8

garbing requirements
hand washing
room requirements
training
cleaning
testing of the environment

Question 9

what does ISO stand for?

Answer 9

international organization of standardization

Question 10

what does ISO do?

Answer 10

ensure that products & services are safe, reliable & of good quality
- used for electronics, IT, engineering, agriculture, etc

Question 11

ISO 3 particle count

Answer 11

35.2/m^3

~1/ft^3

Question 12

ISO 4 particle count

Answer 12

352/m^3

~10/ft^3

Question 13

ISO 5 particle count

Answer 13

3520/m^3

~100/ft^3

Question 14

ISO 6 particle count

Answer 14

35,200/m^3

~1000/ft^3

Question 15

ISO 7 particle count

Answer 15

352,000/m^3

~10,000/ft^3

Question 16

ISO 8 particle count

Answer 16

3,520,000/m^3

~100,000/ft^3

Question 17

ISO 9 particle count

Answer 17

35,200,000/m^3

~1,000,000/ft^3

Question 18

examples of particles

Answer 18

oil, metal shavings, dust, smoke, ash, mold, ect

Question 19

origination of particles

Answer 19

garments, paper, pencils, cosmetics, skin, nail polish, hair, oral secretions

Question 20

everyday particle count of hospital surgery suite

Answer 20

~50,000/ft^3

Question 21

everyday particle count of outdoor air

Answer 21

~200,000-2,000.000/ft^3

Question 22

everyday particle count of indoor air

Answer 22

2 million-10 million/ft^3

Question 23

particle produced by a motionless person

Answer 23

~100,000 particles/minute

Question 24

particles produced by a walking person

Answer 24

~5,000,000 particles/min

Question 25

particles produced by a garbing person

Answer 25

~3,000,000 particles/min

Question 26

ISO class 5

Answer 26

laminar airflow workbench (LAFW), biological safety cabinet (BSC), compounding aseptic containment isolator (CACI), compounding aseptic isolator (CAI)

Question 27

ISO 7

Answer 27

buffer room or ante if connected to chemo room | - room the hoods are in

Question 28

ISO 8

Answer 28

- ante area- , UNLESS connected to chemo room (ISO 7) - where you wash your hands & garb - clean supplies

Question 29

ISO 7 should not have

Answer 29

sinks, floor drains, outer doors, opening windows

Question 30

what class are hoods

Answer 30

ISO 5

Question 31

what kind of pressure should bugger area have?

Answer 31

POSITIVE pressure unless it is a chemo buffer room, then NEGATIVE pressure

Question 32

what do you see in the hood

Answer 32

``` easily cleanable surface minimal supplies light/UV light pole with hooks electric plug filter ```

Question 33

risk level is assigned according to

Answer 33

the probability of contaminating a compounded parenteral with: 1. microbial contaminants 2. physical & chemical contaminants

Question 34

low risk

Answer 34

<8 | - annual testing

Question 35

low risk BUD

Answer 35

Max 48 hours RT max 14 days refrigerated max 45 days frozen

Question 36

low risk

Answer 36

- administration must start no later than 12 hours after preparation - must be made in ISO 5

Question 37

medium risk

Answer 37

> 3 sterile products > 2 entries/product - must be ISO 5<8 - annual testing

Question 38

medium risk BUD

Answer 38

max 30 hours RT max 9 days refrigerated max 45 days frozen

Question 39

high risk

Answer 39

- non-sterile products or equipment - must be 5<8 - semi annual testing

Question 40

high risk BUD

Answer 40

max 24 hour RT max 3 days refrigerated max 45 days frozen

Question 41

immediate use

Answer 41

- nonhazardous meds

Question 42

immediate use BUD

Answer 42

max 1 hour RT or refrigerated

Question 43

single dose BUD

Answer 43

1 hour if worse than ISO 5 (immediate use) 6 hours if ISO 5 ampules shouldnt be stored

Question 44

BUD multiple dose containers

Answer 44

28 days

Question 45

hazardous drugs

Answer 45

chemo or any IV drug that may put the compounder at risk

Question 46

hazardous drugs must be stored

Answer 46

- separate from other inventory | - storage area should be well ventilated with at least 12 air changers per hour (ACPH)

Question 47

where must hazardous drugs be compounded?

Answer 47

ISO 5 biological safety cabinet or compounding aseptic containment isolator

Question 48

for hazardous drugs, must have what buffer room?

Answer 48

``` 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 ```

Question 49

personnel compounding hazardous drugs must be trained & annually tested in:

Answer 49

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

Question 50

what does HEPA stand for

Answer 50

high efficiency particulate air

Question 51

facility requirements

Answer 51

well-lit 20*C (68*C) or cooler buffer area not physically separated from ante areas smooth & cleanable surfaces

Question 52

environment air sampling must be done

Answer 52

every 6 months

Question 53

nonviable air sampling

Answer 53

- do not contain living organisms - designed to directly measure performance of the 1* & 2* engineering controls - Q 6 months

Question 54

viable air sampling

Answer 54

- include PEC, buffer area & ante area & areas prone to contamination (entryway, pass-through boxes) - sample DURING entire compounding process

Question 55

pressure between buffer & ante area

Answer 55

0. 02-0.05 in water column with physical separation | - min velocity of 0.2m/s (40ft/min) w/out separation

Question 56

pressure between ante area & general non-compounding area

Answer 56

no less than 5Pa (0.02in water column)