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Sterile Products > Midterm / Test 1 > Flashcards

Midterm / Test 1 Flashcards

(64 cards)

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1
Q

under section 503A

A

a traditional pharmacy practice is allowed to compound as long as it operates within the triad; such facilities are exempt from the following sections of the federal Food, Drug, and Cosmetic Act of 1938

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2
Q

under section 503B

A

outsourcing facilities must register with the FDA and be inspected by the FDA to ensure that they are following Good Manufacturing Practices; must be compounded or under the direct supervision of a licensed pharmacist

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3
Q

501(a)(2)(B)

A

current Good Manufacturing Practices

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4
Q

502(f)(1)

A

labeling requirements (no package insert)

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5
Q

505

A

compounded preparations do not have to have FDA approval

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6
Q

aseptic processing

A

a mode of processing pharmaceutical and medical products that involves separate sterilization of the product and the package and the transfer of the product into the container and its closure under at least ISO class 5 conditions

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7
Q

preparation

A

also called a CSP; a sterile drug or nutrient compounded in a licensed pharmacy or other healthcare-related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products

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8
Q

product

A

a commercially manufactured sterile drug or nutrient that has been evaluate for safety and efficacy by the FDA; products are accompanied by full prescribing information, which is commonly known as the FDA approved manufacturers labeling or product package insert

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9
Q

purpose of 797 is to prevent: (5)

A

microbial contamination
excessive bacterial endotoxins
variability in the intended strength of correct ingredients that exceeds either monograph limits for official articles
unintended chemical and physical contaminants
ingredients of inappropriate quality in compounded sterile preparations

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10
Q

dosage forms that must comply with 797

A 
aqueous bronchial and nasal inhalation
baths and soaks for live organs and tissues
injections
irrigations for wound and body cavities
ophthalmic drops and ointments
tissue implants
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11
Q

ISO

A

international organization of standards

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12
Q

particulates defined by ISO must be less than

A

5 microns in diameter

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13
Q

PEC

A

Primary Engineering Control

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14
Q

ISO Class 5 must have no more than ___ particles per m^2

A

3520

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15
Q

buffer room:
sterile non hazardous: Class ___ with no more than ___ particles
sterile hazardous: Class ____ with no more than ____ particles

A

7; 352000

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16
Q 
ante room:
sterile on-hazardous: Class \_\_\_\_ with no more than \_\_\_ particles
sterile hazardous: class \_\_\_ with no more than \_\_\_\_ particles
A

8; 3,520,000

7; 352000

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17
Q

ante room

A

connects one or more rooms to the buffer room

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18
Q

requirements of the ante room

A

ceiling sealed, lighting fixtures, nothing can be hanging
walls must be smoothed and painted
floors = 1 solid sheet
shelving, cabinets, and counters cannot be made of wood limited bins
work surfaces / carts should be stainless steel
sinks = automatic
air exchange per hour should not be less than 20!!!
ISO class 7 or 8

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19
Q

buffer room

A

contains the PEC and connects to an ante room; no sources of running water or drains
air exchange should not be less than 30!!!!

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20
Q

SCA

A

segregated compounding area; non classified space or room equipped with a PEC of ISO class 5; should be away from windows, doors, traffic

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21
Q

SCAs are only used for

A

low risk, 12 hour BUD

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22
Q

4 types of SCAs

A

Conventional LAFW
Isolator CAI
Conventional DSC
Isolator CACI

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23
Q

Conventional LAFW

A

horizontal air flow
non hazardous
positive pressure

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24
Q

isolator CAI

A

compounding aseptic isolator
glove box
non hazardous sterile compounding
positive pressure

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25
conventional BSC
vertical hair flow hazardous sterile compounding use negative pressure
26
isolator CACI
compounding aseptic containment isolator glove box hazardous sterile compounding uses negative pressure
27
PECs should be placed in
ISO class 7 buffer room unless it is an isolator with documentation from the manufacturer
28
Peripheral TPN
infusion to IV line; 10-14 days; must be aware of excessive osmolarity to avoid phlebitis
29
central TPN
administered via catheter directly into superior vena cava; allows for greater osmolarity
30
3 types of devices for central TPN
hickman catheter mediport catheter PICC (peripherally inserted central catheter)
31
hickman catheter
subclavian; placement done during surgery checked with Xray; infection is major concern; flush line with heparin
32
mediport catheter
via subclavian vein into superior VC; no external parts; surgical placement; port accessed using special bent needle; flushed with heparin
33
PICC
peripherally inserted central catheter; via the basilic, branchial, cephalic, or medial cubital vein of the arm into the Superior VC, has external lines, NON SURGICAL placement, line flushed with heparin
34
activity factors generally range from
1 - 1.3
35
stress factors generally range from
1.2 - 2.1
36
lipids
EFA 10% = 1.1 kcal/mL 20% = 2 kcal/mL
37
protein
8.4% and 10% | 4 kcal/g
38
carbohydrates
50% and 70% | 3.4 kcal/g
39
EFAs contain phosphatidylcholine that is usually from
egg source
40
__ solutions are acidic
dextrose
41
___ are pH sensitive and should never be mixed with dextrose alone
lipids
42
correct mixing order
AA + dextrose add phosphate add calcium add lipids
43
total fluid volume =
1500 + 20(kg - 20)
44
calcium : phosphate should not be greater than
1 : 2
45
total mEq should not be greater than
45 mEq / L
46
bad phosphate and is less soluble
HPO4^-2
47
risk
odds or probability or chance that the product which is being prepared will be contaminated with bacteria and that those bacteria will survive
48
provide factors that contribute to risk with sterile compounding
``` number of items entered number of products combined purchased as sterile temperature how long the product sits before mixing and packaging how long stored before use number of doses made correct use of garbing, cleansing, aseptic ```
49
immediate use
no hood; clean area, no more than 3 container and 2 sticks to any one container, one dose for one patient, no more than 1 hour between beginning of compounding to start of admin; must remain under supervision of whoever compounded it
50
low risk with 12 hour BUD
no ISO class 7 room; done in PEC of ISO class 5; cannot be near water or heavy traffic, personnel follow cleansing and garbing procedures, no more than 3 containers with 2 sticks to any container, one dose for 1 pt; must have time compounded when finished, no more than 12 hours or less if recommended by package insert
51
low risk
PEC ISO class 5 in ISO class 7 room; limited to transferring, measuring, and mixing manipulations
52
medium risk
one or more of the following conditions are met: multiple doses compounded multiple patients receive CSP more than 3 containers and more than 2 sticks per container process is more complex unusually long duration of compounding process
53
high risk
one or more of the conditions are met: one non-sterile ingredient personnel are improperly garbed / gloved labeling and documentation not verified any of the following are exposed to air quality less than class 5 for more than 1 hour: sterile contents of commercially manufactured products CSPs that lack effective antimicrobial preservatives sterile surfaces of devices and containers for the preparation, transfer, sterilization and packaging of CSPs
54
situations where sterile testing is needed for CSPs
injectable at any extended BUD, high risk with more than 25 single dose packages, CSP is high risk and you make the product in multi-dose containers (no matter how many), high risk and is exposed longer than 12 hours at fridge temp or longer than 6 hours at warmer than fridge temp before being sterilized
55
BUD for low risk: room / fridge / freezer
48 hours / 14 days / 45 hours
56
BUD for low risk (12 hour) : room / fridge / freezer
12 hours / 12 hours / N/A
57
BUD for medium risk: room / fridge / freezer
30 hours / 9 days / 45 hours
58
BUD for high risk: room / fridge / freezer
24 hours / 6 days / 45 hours
59
BUD for immediate: room / fridge / freezer
1 hour / N/A / N/A
60
responsibilities of sterile compounders
how long CSP will remain stable use reputable sellers follow requrements appropriate BUD
61
info located on IV fluid and syringe labels
names and amounts / concentrations for all ingredients directions for use storage conditions precautions to monitor correct pt name and physicians name any reason pt shouldn't hae CSP (check for: __ allergy)
62
finished product release check
inspect product and review compounding procedures review procedures and documents for sterility, correct drug and amount, stability visual check do required tests: sterility, endotoxins, potency, stability
63
what is observed during visual inspection
particulate matter, color, physical integrity of container
64
how to handle a CSP with observed defects
``` DO NOT DISPENSE label CSP and put it somewhere safe pull or check rest of lot report failure to quality control person there must be an investigation to determine why the failure occurred and how to prevent it in the future ```

Sterile Products (3 decks)

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