Lab Final- Sterile Compounding

Sterile products

IV piggybacks, TPN, intramuscular/subcutaneous injections, epidural/intrathecal injections, ophthalmic injections/drops/ointments

Air quality

ISO class 5

Laminar airflow workbench

non-hazardous

horizontal or vertical air flow

positive pressure

biological safety cabinet/vertical flow hood

hazardous drugs

MUST be vertical air flow

glass shield

negative pressure

compounding aseptic isolator

positive pressure

non-hazardous drugs

compounding aseptic containment isolator

negative pressure

hazardous drugs

Ante area ISO class

7 or 8

What is the ante area

separates buffer area from general pharmacy, contains garbing supplies and sink

Line of demarcation

ante area separates dirty side from clean side

Buffer area iso class

7

Buffer area

area where PEC are located and sterile compounding occurs

Positive pressure environment is used for __

non hazardous preparations

Negative pressure environment is used for __

hazardous preparations

Cleanroom suite

dedicated ante room and buffer room

Segregated compounding area

hood located In an unclassified area without an ante room or buffer room

area within 1 meter of the IV hood should be dedicated to sterile compounding

When do we put on hair covers, beard covers, masks, and shoe covers?

In ante area

Explain the steps we must complete before entering the buffer area for non hazardous compounding

put on non-shedding gown

apply alcohol based hand sanitizer and allow to dry

put on sterile gloves (over the cuff for clean room)

apply isopropyl alcohol to sterile gloves and all to dry

Garbing for hazardous drug preparation

double shoe covers, hair cover, face mask, chemo gown, scrub hands for 30 seconds, double gloves

What % alcohol do we apply to gloves?

70

T

T or F we should clean and disinfect the hood every 30 minutes during compounding

If the hood is turned off how long do we run It for before we clean it

30 minutes

Cleaning laminar airflow workbench

cleaning with sterile water removes visible solids

disinfect removes microbial contamination with 70% isopropyl alcohol

pole and hooks

the sides and the work surface working back to front

T

T or F we should work 6 inches in from the outside edge and 3 inches from the back and sides

What is one thing we do not obstruct while preparing a sterile product?

path of first air from reaching critical sites

What hood should chemotherapy agents be prepared in?

class II laminar vertical flow hood

How do we enter the needle into the vial?

with a syringe and needle with the bevel of the needle facing up, the needle should be at 45 degree angle to stopper

How do we withdraw contents from the vial?

add half the volume of air to the vial as the volume to be withdrawn using the milking technique

How do we break the ampule

break it towards base or side of the hood. Do NOT break it towards the HEPA filter, yourself or partner or outside the hood

What do we always need to use to withdraw contents from an ampule or injecting into a final product

filter needle

Spike adaptor

it in inserted into an IV bag to secure the IV tubing set in the bar

the tubing set is attached and primed with the diluent before adding drug to prevent the nurse from exposure when hooking up to the patient

Chemo syringes

membrane covers needle so that the needle is only exposed when attached to the vial adapter

airtight and pressurized

keeps vapors from escaping

Vial adaptors

adaptors are made in various sizes to fit different size vials and curvature of vial stopper

adaptor guides spike to the center of the vial stopper

two fluid channels- one for the drug and one foe gases

hydrophobic barrier- prevents any liquid from leaking out

Female adaptor

attaches to the end of the chemotherapy product

Male adaptor

nurses attaches to the end of the IV line for administration

pushes straight into female adaptor when red lines are aligned

to disconnect pull straight apart at red lines

Closed system

prevents inadvertent chemotherapy exposure to the nurse administering chemotherapy during hookup or disconnecting

PI

package insert

SDV

single dose vial

MDV

multi dose vial

Freezing temperature

-25 to -10 degrees c

refrigerated temperature

2-8 degrees C

Room Temperature

20-25 degrees C

A drug is considered stable as long as

greater than or equal to 90% of the drug molecules are present in their active form

Chemical instability examples

hydrolysis/oxidation, drug-drug molecular interactions, drug-diluent interactions, photo degradation, denaturing

Physical incompatibility

crystallization, precipitation, adsorption/absorption of drug molecules to plastic DEHP component of PVC, leaching of plasticizers

What tells you how long a drug is stable for?

The package insert, trissel's handbook, lexicomp or micromedex, manufacturer, primarily literature

T

T or F dry-rotting of injection port in IV bags is an example of instability

Expiration date

components

Beyond-use date

final product

USP 797 Category 1

compounded under the least controlled environmental conditions In a segregated area or cleanroom suite

USP 797 Category 2

Must be compounded in a cleanroom suite with greater environmental control and testing and dedicated HVAC system

USP 797 category 3

must be compounded in a cleanroom suite with a dedicated HVAC system and the highest level of environmental control and most frequent testing

USP 797 Category 1 BUD IV bag or syringe

room temperature: 12 hours

refrigerated: 24 hours

SDV already in solution BUD category 2

room temperature and refrigerated: 12 hours

bulk package vial already in solution BUD category 2

room temperature and refrigerated: 4 hours

MDV already in solution BUD category 2

room temperature and refrigerated: 28 days

Reconstituted vial of drug in powder form that required reconstitution

per manufacturers PI

Reconstituted single dose vial of drug in powder form that required reconstitution

no longer than 12 hours

For BUD do we use stability or sterility?

whichever is shorter

Product labeling for compounded products

drug, dose, diluent, BUD

For manufacturer labeling how do we label the drugs?

requires drugs to be labeled with total amount of drug and total volume first and largest

What is the purpose of auxiliary labeling

to communicate special requirements to others preparing, handling, delivering, or administering the medication

Examples of auxiliary labelling:

protect from light, refrigerate/ do NOT refrigerate, central line or peripheral line, need to shake or do not shake, filter required, high alert

Examples of high alert drugs at Ruby

insulin, heparin, chemotherapy, concentrated potassium, concentrated sodium, epidural/PCA narcotics, paralytics

What are the 6 things we check

drug, dose, date of stock drug, date of final drug, and the quality of the final product

Purpose of IV Dilutions

IV dilutions are typically prepared for pediatric patients or when a dose cannot be measured accurately using standard concentrations.

Dilutions are required when the dose is smaller than the least measurable volume or when concentration is limited by IV access type.

Use extra caution because one incorrectly prepared dilution could be used for multiple patients.

1) Patient dose is too small to measure accurately (<0.1 mL), 2) Concentration restricted by IV access type (peripheral vs central).

Always verify calculations; use sterile technique; label all dilutions with drug name, concentration, date, and preparer; confirm that final concentration is safe for intended route.

Least Measurable Volume

The smallest labeled graduation on a syringe; defines the minimum measurable volume.

Least Measurable Volume - 1 mL Syringe

0.1 mL; doses smaller than 0.1 mL must be diluted to ensure accuracy.

Concentration Limits by IV Access

Peripheral IV access allows lower concentrations compared to central IV access due to risk of irritation and damage to veins.

Examples of Concentration Limits

Certain drugs may be administered undiluted while others must be diluted before administration.

How to Prepare an IV Dilution

Calculate the desired final concentration and volume, withdraw an aliquot of the drug, and dilute with compatible diluent to achieve the desired concentration.

IV Dilution Calculation

Use ratio and proportion or C1V1 = C2V2 to determine required volumes of stock solution and diluent.

Bulk IV Dilutions

Larger volumes of diluted stock solutions may be prepared for batch use, but each must be verified for concentration and sterility.

Purpose of the Alligation Method

Used to prepare an IV solution of an intermediate concentration using two different strengths of the same ingredient.

When to Use the Alligation Method

When the required concentration cannot be measured directly or prepared using a single stock concentration.

Alligation Principle

The same volume of concentrated dextrose added must be removed from the base solution to maintain total volume.

intradermal

administered in the skin layer

subcutaneous

administered in the subq layer beneath the skin

IM

administered into a muscle

IO

administered into a bone, only in code situations

IV

intravenous

Intrathecal

injection into the CSF

Epidural

injected in the epidural space around the spinal cord

What two products MUST be preservative free

intrathecal and epidural

What two products must be single dose

intrathecal and epidural

Why do we not use multi dose vials for intrathecal or epidural preparations?

they contain preservatives

~ 2 mL

subQ

Steps to administer Subq injection:

1. Wipe the area with alcohol

2. pinch a fold of skin between the thumb and forefinger

3. Insert the needle at a 45 degree angle

4. pull back slightly on the plunger to ensure no blood appears in the syringe

5. slowly push the plunger to administer the medication

6. Remove the needle and dispose

IM injections volume size

0.5 mL- 3 ML

Deltoid - Children < 2 years old, Infants, and individuals with small muscle mass, adults

0.5-1.0 mL

Dorsogluteal (Gluteus Maximus) - Infants

Only recommended in children who have been walking for 1 year

Dorsogluteal (Gluteus Maximus) - Children < 2 years old

Only recommended in children who have been walking for 1 year

Dorsogluteal (Gluteus Maximus) - Children and individuals with small muscle mass

< 2 mL

Dorsogluteal (Gluteus Maximus) - Adults

< 5 mL

Ventrogluteal (Gluteus Medius) - Infants

< 0.5 mL

Ventrogluteal (Gluteus Medius) - Children < 2 years old

< 1 mL

Ventrogluteal (Gluteus Medius) - Children and individuals with small muscle mass

< 2 mL

Ventrogluteal (Gluteus Medius) - Adults

< 4 mL

Vastus Lateralis (Outer Mid-Thigh) - Infants

< 0.5 mL

Vastus Lateralis (Outer Mid-Thigh) - Children < 2 years old

< 1 mL

Vastus Lateralis (Outer Mid-Thigh) - Children and individuals with small muscle mass

< 2 mL