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Parenterals > USP 797 > Flashcards

USP 797 Flashcards

1
Q

What does USP stand for?

A

United States pharmacopeia

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2
Q

USP established

A

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

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3
Q

USP is enforced by who in the us?

A

FDA

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4
Q

chapter 797 first version

A
  • January 1, 2004
  • procedures & requirements for compounding sterile products
  • sets standards that are applicable to all places that prepare sterile products
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5
Q

Chapter 797 revision

A
  • june 1, 2008

- mostly the same contents but additions & clarifications

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6
Q

purpose of 797

A
  • 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
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7
Q

acceditation

A

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

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8
Q

what is included in 797

A 
garbing requirements
hand washing
room requirements
training
cleaning
testing of the environment
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9
Q

what does ISO stand for?

A

international organization of standardization

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10
Q

what does ISO do?

A

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

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11
Q

ISO 3 particle count

A

35.2/m^3

~1/ft^3

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12
Q

ISO 4 particle count

A

352/m^3

~10/ft^3

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13
Q

ISO 5 particle count

A

3520/m^3

~100/ft^3

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14
Q

ISO 6 particle count

A

35,200/m^3

~1000/ft^3

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15
Q

ISO 7 particle count

A

352,000/m^3

~10,000/ft^3

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16
Q

ISO 8 particle count

A

3,520,000/m^3

~100,000/ft^3

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17
Q

ISO 9 particle count

A

35,200,000/m^3

~1,000,000/ft^3

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18
Q

examples of particles

A

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

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19
Q

origination of particles

A

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

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20
Q

everyday particle count of hospital surgery suite

A

~50,000/ft^3

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21
Q

everyday particle count of outdoor air

A

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

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22
Q

everyday particle count of indoor air

A

2 million-10 million/ft^3

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23
Q

particle produced by a motionless person

A

~100,000 particles/minute

24
Q

particles produced by a walking person

A

~5,000,000 particles/min

25
Q

particles produced by a garbing person

A

~3,000,000 particles/min

26
Q

ISO class 5

A

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

27
Q

ISO 7

A

buffer room or ante if connected to chemo room

- room the hoods are in

28
Q

ISO 8

A
  • ante area- , UNLESS connected to chemo room (ISO 7)
  • where you wash your hands & garb
  • clean supplies
29
Q

ISO 7 should not have

A

sinks, floor drains, outer doors, opening windows

30
Q

what class are hoods

A

ISO 5

31
Q

what kind of pressure should bugger area have?

A

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

32
Q

what do you see in the hood

A 
easily cleanable surface
minimal supplies
light/UV light
pole with hooks
electric plug
filter
33
Q

risk level is assigned according to

A

the probability of contaminating a compounded parenteral with:

  1. microbial contaminants
  2. physical & chemical contaminants
34
Q

low risk

A

<8

- annual testing

35
Q

low risk BUD

A

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

36
Q

low risk </+ 12 hour BUD

A
  • administration must start no later than 12 hours after preparation
  • must be made in ISO 5
37
Q

medium risk

A

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

38
Q

medium risk BUD

A

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

39
Q

high risk

A
  • non-sterile products or equipment
  • must be 5<8
  • semi annual testing
40
Q

high risk BUD

A

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

41
Q

immediate use

A
  • nonhazardous meds
    </= 2 entries/product
  • administered w/in 1 hour
  • no label if prep & admin by same person
42
Q

immediate use BUD

A

max 1 hour RT or refrigerated

43
Q

single dose BUD

A

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

44
Q

BUD multiple dose containers

A

28 days

45
Q

hazardous drugs

A

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

46
Q

hazardous drugs must be stored

A
  • separate from other inventory

- storage area should be well ventilated with at least 12 air changers per hour (ACPH)

47
Q

where must hazardous drugs be compounded?

A

ISO 5 biological safety cabinet or compounding aseptic containment isolator

48
Q

for hazardous drugs, must have what buffer room?

A 
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
49
Q

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

A

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

50
Q

what does HEPA stand for

A

high efficiency particulate air

51
Q

facility requirements

A

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

52
Q

environment air sampling must be done

A

every 6 months

53
Q

nonviable air sampling

A
  • do not contain living organisms
  • designed to directly measure performance of the 1* & 2* engineering controls
  • Q 6 months
54
Q

viable air sampling

A
  • include PEC, buffer area & ante area & areas prone to contamination (entryway, pass-through boxes)
  • sample DURING entire compounding process
55
Q

pressure between buffer & ante area

A
  1. 02-0.05 in water column with physical separation

- min velocity of 0.2m/s (40ft/min) w/out separation

56
Q

pressure between ante area & general non-compounding area

A

no less than 5Pa (0.02in water column)

Parenterals (4 decks)

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