433 - Midterm 1

Question 1

Compounded Sterile Products
CSPs

Answer 1

Sterile Drugs
Injections

Irrigations

Pulmonary Inhalations

Opthalmics

Implants

Question 2

What type of Pressure?

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

Answer 2

NEGATIVE PRESSURE

Required for Hazardous drug prep.

Buffer Area at least < Iso 7

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

Question 3

What ISO must be the CRITICAL AREAS ?

(hood / closest to sterile drugs)

Answer 3

ISO 5

Question 4

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

Iso Class 5

Answer 4

Beginning of each Shift

Before & after a batch

After Spills

Anytime CONTAMINATION is suspected

Question 5

How often do we clean

Counters / Work surfaces / Floors

Answer 5

DAILY

Question 6

How often do we clean?

Walls / Ceiling / Shelves

Answer 6

MONTHLY

Question 7

BSC = Chemo Hood

Type of Hood

Answer 7

NEGATIVE PRESSURE hood

used to prepare Hazardous CSPs

Question 8

Isolators = Glove Boxes

​Type of Hood

Answer 8

Completely enclosed type of PEC

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

CACIs (containment)
NEGATIVE pressure for HAZARDOUS DRUGS

Question 9

IVLFZ
Integrated Verical Laminar Flow Zones

​Type of Hood

Answer 9

HEPA FILTER IN CEILING
over stainless steel work tables

“open Architecture”

Question 10

SVP vs LVP

Answer 10

Small <100mL

Large >100mL

Question 11

Where are HAZARDOUS DRUGS prepared?

Answer 11

VERTICAL BSC

in

NEGATIVE PRESSURE FASCILITY

USP 800 = Hazardous Drugs

Question 12

RED SHARPS WASTE

Answer 12

SHARPS = RED

Needles / Syringes

Broken Ampoules / Vials
WITH or WITHOUT drug remaining

Question 13

Black Waste

Answer 13

Pharmaceutical / Drug Waste

Question 14

RED BIOLOGICAL WASTE

Answer 14

Blood / Human Products

Question 15

Yellow Waste

Answer 15

Yellow = HAZARDOUS DRUGS

ALL material that were in the hood while compounding

Outer gown materials too

Question 16

When can Drug go into general trash?

Answer 16

• *<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

Question 17

Incompatibility

Answer 17

When 2+ ingredients interact causing an

UNDESIRABLE / ADVERSE AFFECT
VVVV
Product +/- Efficacy

Ex.
Precipitation Reaction

Question 18

INSTABILITY

Answer 18

When a compound

UNDERGOES DEGRADATION

Ex.
Rotting Food –> no longer edible

Question 19

TNA

Answer 19

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

PN + IV Fat Emulsion

Question 20

IVFE considerations

Answer 20

IV Fat Emulsion = Lipids

Can CRACK with:

freezing or heating

HIGH pH

contact with HIGH CONCENTRATIONS OF DEXTROSE

Seperate Dextrose & lipids

Question 21

Order of Mixing for TPN

Answer 21

LIPIDS & DEXTROSE SEPERATE!
PROTEIN IN BETWEEN

MULTIPLE VITAMIN NEAR LAST
due to yellow color

• *Phos + Calcium**
• *also Avoid MAG Sulfate (do not DIRECTLY mix)**

Question 22

Calcium Phosphate Solubility Curve

Answer 22

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

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

Question 23

Physical Incompatibilites
that can lead to PRECIPITATION

Answer 23

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

Question 24

Chemical Incompatibilities

Answer 24

Hydrolysis

Oxidation

Isomerization / POLYmerization

Complexation / Combination

Decarboxylation

Question 25

**Zero Order Reaction** **Half Life & Shelf Life**

Answer 25

_ZERO ORDER_ **t_1/2 = 1/2 A₀/k** **t_s = 1/10 A₀/k** **DEPENDS ON A₀ = Starting Amount** & **LINEAR**

Question 26

**First Order Reactions** **Half Life & Shelf Life**

Answer 26

_FIRST ORDER_ **t_1/2 = ln(2) / k** **t_s = ln(10/9) / k** *Starting amount DOES NOT matter* **EXPONENTIAL DECAY**

Question 27

**Suspensions** Zero or 1st order?

Answer 27

***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

Question 28

**Definition of Half Life**

Answer 28

**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

Question 29

**Solution** **Zero or 1st Order?**

Answer 29

**FIRST ORDER** *doesnt matter the starting amount*

Question 30

**Effect of BUFFER Concentration**

Answer 30

**COULD EITHER INCREASE OR DECREASE** If.... * *Faster degradation = *lower shelf life*** * *↑[Buffer] --\> ↑K** vvvvv **INCOMPATIBILITY**

Question 31

**pH & Temperature** **Chemical Incompatibility**

Answer 31

**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

Question 32

**Antioxidant & Salt Forms** **Chemical Incompatabilities**

Answer 32

**Antioxidants can be ADDED to address incompatibilities** **SALT FORMS MATTER** determine the particular shelf life

Question 33

**Charged Molecules** **Physical Incompatibilities**

Answer 33

**Charged Molecules = MUCH MORE SOLUBLE** Sometimes use this to keep API in solution

Question 34

**pH for Phos-Calcium** **Physical Incompatibilities**

Answer 34

**LOWER pH is BETTER** pH controls what **Phos-Calcium precipitate is formed** **SOLUBILITY CONTROL** mixing is bad --\> cause pH imbalance --\> precipitation

Question 35

**Preservative + Surfactants** **Precipitation Physical Incompatibility**

Answer 35

**Charged Surfactants** can result in **PRECIPITATION** of **exipients or API** ## Footnote **High Concentration + Charged States**

Question 36

**Protein + Surfactant PRECIPITATION** Physical Incompatibility

Answer 36

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

Question 37

**Eutetic Mixtures** Physical Incompatibilities

Answer 37

**LIDOCAINE + DECANOIC ACID** **Solid + Solid --\> LIQUID** can use as a positive as well though **HYDROSCOPICITY** is ALSO a physical incompatibility

Question 38

**What Affects** **i = Van't Hoff's Factor**

Answer 38

Influenced by: **_MOLALITY_** which is affected by **CONCENTRATION** at a **greater Molality** (greater concentration) VVV **i = greater than theoretical value**

Question 39

* *Colligative Properties** of **Solutions** * *_DEPEND ON WHAT?_** **Vapor Pressure *lowering*** **Boiling Point ELEVATION** **Freezing Point *depression*** **Osmotic Pressure**

Answer 39

_RATIO OF:_ **# of Solute Particles** **# of Solvent Molecules** (mass of solvent) in solution

Question 40

**Osmotic Pressure**

Answer 40

**Pressure that is PUT ON WATER** to ## Footnote **Move it from 1 side to another**

Question 41

**When is it VITAL to have ISOTONIC products?**

Answer 41

**_PARENTERALS_** **Opthalmic** **IV / SC** **Rectal / Vaginal** in contact DIRECTLY w/ cells

Question 42

Relationship between ## Footnote **Tonicity & Osmolarity**

Answer 42

**Tonicity** is dependent on **# of particles in solution** * *TONICITY =/= Osmolarity** * but is _NEARLY_ equivalent* **Osmolarity & Osmolality** can be used to **PREDICT TONICITY**

Question 43

**Colligative Properties** **DEPEND ON WHAT?**

Answer 43

**# of PARTICLES in a SOLUTION**

Question 44

**Solubility of** **NON-Electrolytes vs ELECTROLYTES**

Answer 44

**Non-Electrolytes --\> one particle** **STRONG ELECTROLYTES** VVV **Complete Dissolution** Electrolytes ideally dissociate **upon solubilization based on # of ions in the molecule**

Question 45

Do **Electrolytes + Non-Electrolytes** ## Footnote **follow IDEAL COLLIGATIVE PROPERTIES?**

Answer 45

**NO** Electrolytes + non-electrolytes **DO NOT follow IDEAL colligative properties**

Question 46

**IsoOsmotic Solutions** ## Footnote **can be CREATED by WHICH METHODS?**

Answer 46

**FREEZING POINT DEPRESSION** **NaCl EQUIVALENT** **MIXING METHOD**s

Question 47

**USP 797**

Answer 47

Describes the **_MINIMUM_** **standards** to be followed when preparing **compounded STERILE human & animal DRUGS** Standards BEYOND USP 797 are defined by the facility

Question 48

**Products that are REQUIRED to follow** **USP 797**

Answer 48

**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

Question 49

Who **DOESN'T** have to follow **797?**

Answer 49

**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_

Question 50

**ACPH** Recertification every **6 mo** or **after room changes** Airflow testing Hepa Filter Integrity Total particle count PEC smoke study

Answer 50

**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*

Question 51

**Beyond Use Dates = BUD's**

Answer 51

* *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**

Question 52

**Low Risk level** **BUD = 48 Hours @ room temp** used to determine BUD along with Categories

Answer 52

**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

Question 53

**Low Risk w/ 12 hour or less BUD** used to determine BUD along with Categories

Answer 53

* *Iso class 5 PEC** * *_NOT LOCATED IN ISO CLASS 7 AIR_** Sinks should be adjacent to PEC **no hazardous compounding**

Question 54

**Medium Risk** **BUD = 30 Hours @ room Temp** used to determine BUD along with Categories

Answer 54

_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

Question 55

**High Risk** **BUD = 24 hours @ room temp** used to determine BUD along with Categories

Answer 55

Materials exposed to air **\< Class 5** for **\> 1 hour** Personnel **improperly garbed** Use of **non-sterile starting materials** **Must be STERILIZED prior to administration**

Question 56

**Category 1 CSP vs Cat 2 CSP** **KNOW DIS**

Answer 56

_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**

Question 57

**SIngle Dose Vial COnsiderations**

Answer 57

**Punctured OUTSIDE of ISO CLASS 5** air = **use within 1 hour** Punctured **_INSIDE of Iso Class 5 PEC_ use within _6 hours_**

Question 58

**USP 800 Sterile Compounding** Still follows ALL 797 Guidelines * *CSTD is RECOMMENDED** **during compounding** * *but is REQUIRED during ADMIN**

Answer 58

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