Sterile Products Exam

USP

Sterile products

Revised USP

Must be prepared in an ISO Class 5 or better, that may be placed in an unclassified segregated compounding area (SCA) and have shorter BUDs

Revised USP

Must be prepared in a cleanroom suite and have longer BUDs

Revised USP

-May be assigned longer BUDs than limits set for Category 2 up to a maximum of 180 days

-Undergo sterility testing

-Have more requirements than Category 2 for personnel qualification, use of sterile garb, use of sporicidal disinfectants, frequency of environmental monitoring, and stability determination

Revised USP

1. ≤12 hours at CRT

2. ≤24 hours in refrigerator

Revised USP

1. 4 days at CRT

2. 10 days in refrigerator

3. 45 days in freezer

Revised USP

1. 1 day at CRT

2. 4 days in refrigerator

3. 45 days in freezer

Revised USP

1. 30 days at CRT

2. 45 days in refrigerator

3. 60 days in freezer

Revised USP

1. 14 days at CRT

2. 28 days in refrigerator

3. 45 days in freezer

Revised USP

1. 45 days CRT

2. 60 days in refrigerator

3. 90 days in freezer

Revised USP

1. 60 days at CRT

2. 90 days in refrigerator

3. 120 days in freezer

Revised USP

1. 90 days at CRT

2. 120 days in refrigerator

3. 180 days in freezer

List some topics covered in the content of USP

1. CSP Microbial Contamination Risk Categories

2. Personnel Training and Evaluation in Aseptic Manipulation Skills

3. Single-Dose and Multiple-Dose Containers

4. Verification of Automated Compounding Devices

5. Patient Monitoring and Adverse Events Reporting

6. Storage and Beyond-Use Dating

7. Patient or Caregiver Training

What is a CSP?

Compounded sterile preparation

What is the exception to the USP

Immediate-Use CSPs (exempt from all requirements)

Direct Compounding Area (DCA) corresponds to...

surface in hood

Primary Engineering Control (PEC) corresponds to...

hood

Required Facility Design for USP

1. Must have an ISO Class 5 environment as a PEC

2. Must have an ISO Class 7 environment for buffer area or cleanroom

3. Must have an ISO Class 8 environment for ante areas

Aseptic Technique

procedure which is designed to prevent contamination of materials, instruments, utensils, and containers during handling

Horizontal Flow or Laminar Flow Hood

air blows towards worker, used for non-chemotherapy preparations

Vertical Flow or Biological Safety Cabinet

air blows from top down to maintain sterility and protect the worker, used to make chemotherapy

In a Horizontal Flow/Laminar Flow Hood, all aseptic manipulations should be performed at least ___ inches within the hood

6 inches

True or False. Is it okay to come in contact with the HEPA filter when cleaning before use.

False

Using aseptic technique, which part(s) of a syringe should NEVER be touched?

Tip or Plunger

Graduation (in mL) of 60 mL syringe

1.0

Graduation (in mL) of 30 mL syringe

1.0

Graduation (in mL) of 20 mL syringe

1.0

Graduation (in mL) of 10 mL syringe

0.2

Graduation (in mL) of 5 mL syringe

0.2

Graduation (in mL) of 3 mL syringe

0.1

Graduation (in mL) of 1 mL syringe

0.01

DO NOT use syringes whose graduations are greater than ________ the volume being measured

twice

Luer-Lok tip

Syringe barrel

Calibration marks

Syringe piston

Syringe plunger

Needle hub

Needle bevel

Needle shaft

D value

time in minutes required to destroy 90% of microbes under a standard set of conditions (ex. 10^6 organisms goes to 10^5 after 1 minute)

Phlebitis

inflammation of a vein (reduced when IV infusions are filtered - final filter)

Antimicrobial agents that kill organisms are...

bacteriocidal

Antimicrobial agents that prevent growth of organisms are...

bacteriostatic

Few microorganisms grow below a pH of ___, or above pH ___

3;9

Primary source of pyrogen contamination in sterile products

water used as the solvent or during processing

Large-volume intravenous solutions

injections containing more than 100 mL of solution intended for IV use

Small-volume injections

injections of 100 mL or less, may be either single or multi dose products

Intradermal (ID) injection area

just below the surface of the skin (interface of epidermis and dermis), often used for skin tests

Intradermal (ID) injection volumes

usually 0.1 mL, may be as small as 0.02 mL, and as large as 0.5 mL

Intradermal (ID) syringe and needle sizes

-1 mL syringes, often labeled "tuberculin"

-25 to 28G, 3/8 to 5/8 inch

Subcutaneous (SC, SQ) injection area

subcutaneous fat tissue between the dermis and muscle

Subcutaneous (SC, SQ) injection volumes

limited to approximately 1 mL

Subcutaneous (SC, SQ) syringe and needle sizes

-1 or 3 mL syringes

-Needle size depends on use

Intramuscular (IM) injection area

deltoid, vastus lateralis, gluteus maximus

Intramuscular (IM) injection volumes for adults

-Up to 2 mL may be given in deltoid

-Up to 5 mL in gluteal medial muscle

Intramuscular (IM) injection volumes for children

-Vastus lateralis muscle is recommended in children under 3

-For children up to 3 years, the max volume is 1 mL

Intravenous (IV) injection area

Veins

Intravenous (IV) syringe and needle sizes

-1 to 60 mL syringe

-20 to 22G, 1/2 to 1 1/2 inch

Types of IVs (3)

1. Continuous or constant infusion

2. Intermittent

3. Bolus or IV push

Continuous IV (constant infusion)

the solution is slowly and continuously dripped into a vein

Intermittent IV

drug is given in an intermediate of time (15-60 min) at spaced intervals (ex. every 6 hours)

IV push or bolus

drug is placed in a syringe and administered in a short period of time (minutes) directly into vein or IV tubing (may be one time or repeated at spaced intervals)

If the drug volumes are equal, the priming volume...

may be split equally (one-half for each drug)

If the drug volumes are unequal, the priming volume...

must have the same proportion of each drug solution as in the dose volume (must calculate)

True or False. Drug absorption is usually faster after IM injection than SC injection.

True

Fick's First Law Equation (sink conditions)

DC/I

Fick's First Law Equation (amount/time)

ADC/I

Where does the oil/water partition coefficient go in Fick's First Law Equation if present?

Denominator

A high oil/water partition coefficient ____________ release by lowering rate of diffusion

prolongs

The major use of suspensions injected IM or SC

to provide a slow release prolonged effect with a single dose

Most widely used approach for rate limiting absorption of IM or SC suspensions

use a relatively insoluble drug

For an IM drug suspension, duration of drug absorption decreases with...

a decrease in particle size

If a parenteral suspension is injected IV, it must have a particle size less than ___________ microns and must be biodegradable

0.5-1 (µm)

Aqueous solution absorption path

injection site, diffusion, capillary

Aqueous suspension absorption path

injection site (particles), dissolution, injection site, diffusion, capillary

Oil solution absorption path

injection site (droplets), partitioning, injection site, diffusion, capillary

In cortisone acetate suspension, which component is the preservative?

Benzyl alcohol

Intact drugs are usually ___________ and form ___________ oxidation products

colorless; colored

Primary cause of the rancidity of fats and natural oils (Triglycerides)

Oxidation

List some common antioxidants (3)

-Tocopherol (Vitamin E)

-EDTA (metal chelator)

-Sulfites (oxygen scavenger)

List some containers that can help prevent photolysis

1. Amber vials

2. Aluminum foil

Incompatibility

medication error of dosage forms from compounding, dispensing, or administration

Physical Incompatibility

precipitation of unionizable (neutral) drug after dilution of solubilizing agent

Absorption

lipophilic drugs and preservatives in solution partition into plastics and rubber

Adsorption

drug in solution adhere to a surface (ex. plastic surfacers, filter membranes)

pH of 5% Dextrose Injection

3.5-6.5

A protein has its ___________ solubility at its isoelectric point (no net charge)

lowest

True or False. Hydrochloride salts of weak bases are the most common.

True

List some common cosolvents (5)

1. Propylene glycol

2. Polyethylene glycol (PEG)

3. Ethanol

4. Glycerol

5. Dimethylacetamide

Citric acid is commonly used as a ___________ in injections

pH adjustor

List the two most common nonionic surfactants

1. Tween 80

2. Cremophor EL

Surfactants assemble into a micelle at the...

critical micelle concentration (CMC)

Cyclodextrans are relatively nontoxic cyclic oligomers of ___________ that form inclusion complexes with drugs

Dextrose

Lecithin is a ___________ and adsorbs at the oil-water interface in emulsions

surfactant

IV Admixture

the preparation of pharmaceutical product which requires the measured addition of a medication to a 50 ml or greater bag or bottle of IV fluid

High risk patient groups for IV Admixtures (6)

1. Patients with renal/liver impairment

2. Neonates

3. Elderly/chronically ill

4. Patients on multiple medications

5. Oncology patients

6. Pregnant/breastfeeding mothers

List the different types of stability issues that may arise (4)

1. Chemical

2. Physical

3. Therapeutic

4. Microbiological

List the advantages of DHEP in IV bags and tubing (5)

1. Flexibility

2. Strength

3. Temperature tolerant

4. Stability

5. Resistance to kinking

List the disadvantages of DHEP in IV bags and tubing (4)

1. Leaching

2. Drug incompatibility

3. Risk of harmful exposure

4. Reproductive toxicity