Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Ceutics > 433 - Midterm 1 > Flashcards

433 - Midterm 1 Flashcards

1
Q

Compounded Sterile Products
CSPs

A

Sterile Drugs
Injections

Irrigations

Pulmonary Inhalations

Opthalmics

Implants

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What type of Pressure?

Airflow is flowing INWARD (into hood or room)
and
vented to the outside

A

NEGATIVE PRESSURE

Required for Hazardous drug prep.

Buffer Area at least < Iso 7

Ante area that opens into NEG-ressure room < iso 7

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What ISO must be the CRITICAL AREAS ?

(hood / closest to sterile drugs)

A

ISO 5

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

When to CLEAN the PEC?
primary Engineering Control = Hood / isolator

Iso Class 5

A

Beginning of each Shift

Before & after a batch

After Spills

Anytime CONTAMINATION is suspected

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

How often do we clean

Counters / Work surfaces / Floors

A

DAILY

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

How often do we clean?

Walls / Ceiling / Shelves

A

MONTHLY

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

BSC = Chemo Hood

Type of Hood

A

NEGATIVE PRESSURE hood

used to prepare Hazardous CSPs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Isolators = Glove Boxes

​Type of Hood

A

Completely enclosed type of PEC

2 Types:
CAIs = Positive Pressure, for non-hazardous drugs

CACIs (containment)
NEGATIVE pressure for HAZARDOUS DRUGS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

IVLFZ
Integrated Verical Laminar Flow Zones

​Type of Hood

A

HEPA FILTER IN CEILING
over stainless steel work tables

“open Architecture”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

SVP vs LVP

A

Small <100mL

Large >100mL

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Where are HAZARDOUS DRUGS prepared?

A

VERTICAL BSC

in

NEGATIVE PRESSURE FASCILITY

USP 800 = Hazardous Drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

RED SHARPS WASTE

A

SHARPS = RED

Needles / Syringes

Broken Ampoules / Vials
WITH or WITHOUT drug remaining

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Black Waste

A

Pharmaceutical / Drug Waste

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

RED BIOLOGICAL WASTE

A

Blood / Human Products

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Yellow Waste

A

Yellow = HAZARDOUS DRUGS

ALL material that were in the hood while compounding

Outer gown materials too

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

When can Drug go into general trash?

A
  • *<3%** of drug remaining
  • *intact glass can go into general trash**

Broken Glass w/ <3% drug can go into glass trash

More Drug –> Pharmaceutical Black WAste

More drug in glass –> Sharps container

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Incompatibility

A

When 2+ ingredients interact causing an

UNDESIRABLE / ADVERSE AFFECT
VVVV
Product +/- Efficacy

Ex.
Precipitation Reaction

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

INSTABILITY

A

When a compound

UNDERGOES DEGRADATION

Ex.
Rotting Food –> no longer edible

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

TNA

A

Total Nutrient Admixture = TNA
aka TPN = 3 in 1 infusion

PN + IV Fat Emulsion

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

IVFE considerations

A

IV Fat Emulsion = Lipids

Can CRACK with:

freezing or heating

HIGH pH

contact with HIGH CONCENTRATIONS OF DEXTROSE

Seperate Dextrose & lipids

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Order of Mixing for TPN

A

LIPIDS & DEXTROSE SEPERATE!
PROTEIN IN BETWEEN

MULTIPLE VITAMIN NEAR LAST
due to yellow color

  • *Phos + Calcium**
  • *also Avoid MAG Sulfate (do not DIRECTLY mix)**
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Calcium Phosphate Solubility Curve

A
  • *Concentration BELOW the curve = OKAY**
  • *Safety Zone Area**

Curve will shift up into the Danger Zone Area
As pH increases (acidic) from AA’s

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Physical Incompatibilites
that can lead to PRECIPITATION

A

Dilution of non-aqueous solutions

Mixing of APIs formulated at VARYING pH

Mixing of SALTS

Charged SURFACTANTS
+ Protein or +Preservative

HYDROSCOPICITY
is also a physical incompatibility

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Chemical Incompatibilities

A

Hydrolysis

Oxidation

Isomerization / POLYmerization

Complexation / Combination

Decarboxylation

25
Q

Zero Order Reaction

Half Life & Shelf Life

A

ZERO ORDER

t1/2 = 1/2 A0/k

ts = 1/10 A0/k

DEPENDS ON A0 = Starting Amount
&
LINEAR

26
Q

First Order Reactions

Half Life & Shelf Life

A

FIRST ORDER

t1/2 = ln(2) / k

ts = ln(10/9) / k

Starting amount DOES NOT matter

EXPONENTIAL DECAY

27
Q

Suspensions

Zero or 1st order?

A

Thought to be First order

but…

ACT AS ZERO ORDER REACTION
API in the solution is going to degrade over time

Water Vs API

STARTING AMOUNT MATTERS

28
Q

Definition of Half Life

A

Point when

90%

of API is remaining

Unless therapeutic index is close to 1 & more stringent dosing is needed

Unless TOXIC or differentially active products are produced

29
Q

Solution

Zero or 1st Order?

A

FIRST ORDER

doesnt matter the starting amount

30
Q

Effect of BUFFER Concentration

A

COULD EITHER INCREASE OR DECREASE

If….

  • *Faster degradation = lower shelf life**
  • *↑[Buffer] –> ↑K**

vvvvv

INCOMPATIBILITY

31
Q

pH & Temperature

Chemical Incompatibility

A

CAN DO EITHER!

Sometimes the Buffer won’t freeze
VVV
Acidic environment –> degrade API –> ↓Shelf Life

Even though we expect dropping temperature to increase shelf life / stop degradation

32
Q

Antioxidant & Salt Forms

Chemical Incompatabilities

A

Antioxidants can be ADDED to address incompatibilities

SALT FORMS MATTER
determine the particular shelf life

33
Q

Charged Molecules

Physical Incompatibilities

A

Charged Molecules = MUCH MORE SOLUBLE

Sometimes use this to keep API in solution

34
Q

pH for Phos-Calcium

Physical Incompatibilities

A

LOWER pH is BETTER

pH controls what Phos-Calcium precipitate is formed

SOLUBILITY CONTROL

mixing is bad –> cause pH imbalance –> precipitation

35
Q

Preservative + Surfactants

Precipitation
Physical Incompatibility

A

Charged Surfactants can result in
PRECIPITATION
of exipients or API

High Concentration + Charged States

36
Q

Protein + Surfactant
PRECIPITATION

Physical Incompatibility

A

Surfactants MASKS charges on protein
VVV
Allows protein to COME TOGETHER
Charged AA regions = hydrophylic
& hydrophobic regions come together
VVV
PRECIPITATE

37
Q

Eutetic Mixtures

Physical Incompatibilities

A

LIDOCAINE + DECANOIC ACID

Solid + Solid –> LIQUID

can use as a positive as well though

HYDROSCOPICITY
is ALSO a physical incompatibility

38
Q

What Affects

i = Van’t Hoff’s Factor

A

Influenced by:
MOLALITY which is affected by CONCENTRATION

at a greater Molality (greater concentration)
VVV
i = greater than theoretical value

39
Q
  • *Colligative Properties** of Solutions
  • *DEPEND ON WHAT?**

Vapor Pressure lowering

Boiling Point ELEVATION

Freezing Point depression

Osmotic Pressure

A

RATIO OF:

# of Solute Particles

# of Solvent Molecules (mass of solvent)

in solution

40
Q

Osmotic Pressure

A

Pressure that is PUT ON WATER to

Move it from 1 side to another

41
Q

When is it VITAL to have ISOTONIC products?

A

PARENTERALS

Opthalmic

IV / SC

Rectal / Vaginal

in contact DIRECTLY w/ cells

42
Q

Relationship between

Tonicity & Osmolarity

A

Tonicity is dependent on # of particles in solution

  • *TONICITY =/= Osmolarity**
  • but is NEARLY equivalent*

Osmolarity & Osmolality
can be used to

PREDICT TONICITY

43
Q

Colligative Properties

DEPEND ON WHAT?

A

# of PARTICLES in a SOLUTION

44
Q

Solubility of

NON-Electrolytes vs ELECTROLYTES

A

Non-Electrolytes –> one particle

STRONG ELECTROLYTES
VVV
Complete Dissolution

Electrolytes ideally dissociate
upon solubilization based on # of ions in the molecule

45
Q

Do Electrolytes + Non-Electrolytes

follow IDEAL COLLIGATIVE PROPERTIES?

A

NO

Electrolytes + non-electrolytes

DO NOT follow IDEAL colligative properties

46
Q

IsoOsmotic Solutions

can be CREATED by WHICH METHODS?

A

FREEZING POINT DEPRESSION

NaCl EQUIVALENT

MIXING METHODs

47
Q

USP 797

A

Describes the MINIMUM standards to be followed when preparing compounded STERILE human & animal DRUGS

Standards BEYOND USP 797
are defined by the facility

48
Q

Products that are REQUIRED to follow

USP 797

A

Anything sterile –> goes INTO BLOOD STREAM

Injections / Irrigations (internal)

Opthalmics / Inhalations (not sprays)

Baths/soaks for LIVE organs / tissues

Implants

Hazardous Drugs = 800

Radiopharmaceuticals = 825

49
Q

Who DOESN’T have to follow 797?

A

Non-Hazardous CSPs used WITHIN 1 HOUR

Propietary bag & Vial systems
must be admin IMMEDIATELY after docking/activating

Allergenic Extracts

must STILL proper ASEPTIC TECHNIQUE

50
Q

ACPH

Recertification every 6 mo or after room changes

Airflow testing
Hepa Filter Integrity
Total particle count
PEC smoke study

A

Airflow is measured in the # ACPH = Air changes per Hour

OPPOSITE

Iso Class 8 > 20 ACPH

Iso Class 7 > 30 ACPH

Room guage must not read <0.02 inch water pressure

51
Q

Beyond Use Dates = BUD’s

A
  • *Date & Time** after which admin of product must
  • *NOT BEGIN**

“How long the product is STERILE”

Time starts from the time compoinding is INITIATED

Based on risk of developing microbial contamination

BUD =/= Experiation Dat

52
Q

Low Risk level

BUD = 48 Hours @ room temp

used to determine BUD along with Categories

A

Iso Class 5 PEC

Pec is also inside ISO Class 7 buffer area

<3 containers // < 2 entries into a container

90% of preps are in low risk

53
Q

Low Risk w/ 12 hour or less BUD

used to determine BUD along with Categories

A
  • *Iso class 5 PEC**
  • *NOT LOCATED IN ISO CLASS 7 AIR**

Sinks should be adjacent to PEC

no hazardous compounding

54
Q

Medium Risk

BUD = 30 Hours @ room Temp

used to determine BUD along with Categories

A

Same as low risk
Iso Class 5 PEC
PEC is also in ISO Class 7 buffer area

BATCH OR BULK COMPOUNDING

mixture with > 3 containers // 5 doses from bulk // TPN

55
Q

High Risk

BUD = 24 hours @ room temp

used to determine BUD along with Categories

A

Materials exposed to air < Class 5 for > 1 hour

Personnel improperly garbed

Use of non-sterile starting materials

Must be STERILIZED prior to administration

56
Q

Category 1 CSP vs Cat 2 CSP

KNOW DIS

A

Cat 1 CSP

  • PEC NOT required to be in classified area*
  • *<12 hour BUD**

Cat 2 CSP
PEC REQUIRED to be in a CLASSIFIED AREA
= CLEAN ROOM

Non sterile = 1 day BUD

Sterile = 4 Day BUD

57
Q

SIngle Dose Vial COnsiderations

A

Punctured OUTSIDE of ISO CLASS 5 air
= use within 1 hour

Punctured INSIDE of Iso Class 5 PEC
use within 6 hours

58
Q

USP 800 Sterile Compounding

Still follows ALL 797 Guidelines

  • *CSTD is RECOMMENDED** during compounding
  • *but is REQUIRED during ADMIN**
A

Buffer Room Guidelines:

  • *HVAC –> vented EXTERNALLY**
  • *Negative Pressure** (0.01 - 0.03 water column to adj rooms)

Hood Guidelines:
HVAC + Extenal Vent
MINIMUM > Iso Class 5 BSC or CACI (not CAI)

2 gloves, no need for 2 of others

Ceutics (2 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions