Aseptic Technique and Sterile Compounding of Intravenous Admixtures

Question 1

What does the term Aseptic technique refer to?

What is it designed to do?

Answer 1

term used for all procedures and techniques performed to keep a sterile product from becoming contaminated.

designed to ensure the aseptic preparation of
sterile products.

Question 2

What are the responsibilities of compounding personnel?

Answer 2

1. follow precise verbal/written directions
2. calculate mathematical equations
3. operate specialised equipment
4. measurement and dilution
5. labelling and dispensing
6. use sterile equipment properly

Question 3

CSPs must be free from________

Answer 3

living organisms
particles
pyrogens
bacterial toxins

Question 4

Special CSPs include_______

CSPs stands for

Answer 4

High risk preparations
Hazardous drugs
Radiopharmaceuticals
Allergy extracts

Compounded sterile preparations

Question 5

What is the role of sterile compounding in pharmacy?

Answer 5

1. following precise steps to prevent infections, errors, and unsafe preparations.
2. So you can distinguish if patient infection is due to disease or because of pharmacy error.
3. to compound for animals and humans

Question 6

List the type of parenteral dosage forms.
Which is the most common?

Answer 6

1. Basic Intravenous Therapy (IV) (most common)
2. intramuscular (IM)
3. subcutaneous (SQ, SC)
4. intradermal (ID)
5. epidural

Question 7

IV fluids come in LVP.
What is the volume?
What does it usually contain?

Answer 7

large-volume parenteral
more than 100 mL
usually a simple solution of dilute dextrose,
sodium chloride or both.

Question 8

Characteristics of Basic IV Therapy

Answer 8

1. Hang on an IV pole 36 inches higher than the patient’s bed.
2. Solution is infused continually to keep blood from clotting in the catheter and plugging the line.
3. Primary IV set attaches to the LVP.
   common features of IV set: Drip chambers
4. Electronic infusion devices used in fluid restricted patients or when the LVP cannot be monitored by using the gravity method.

Question 9

How are drip chambers in primary IV sets classified?

Answer 9

based on the size of the drop that is formed in the drip chamber.

a. Macrodrip – deliver 10 to 20 drops/mL
b. Minidrop or Microdrip – deliver 60 drops/mL

Question 10

What does Secondary IV sets refer to?

Answer 10

Drugs that are routinely delivered through the same basic IV setup are usually attached to a “secondary IV set” connected to the primary set

Question 11

What are the two types of catheters?
Describe them.

Answer 11

1. Central Venous Catheter
   direct access into a vein that has a high flow of blood.
   temporary or permanent
   fewer restrictions in terms of type and rate of administration
2. Peripheral Venous Catheter
   long flexible catheter that travels through the vein and its tip ends near the heart.
   plastic (most common) or steel (aka scalp veil or butterfly.
   More common since it is less risky and less complicated.

Question 12

What are the risks of Risks of Intravenous Therapy?

Answer 12

1. Infection if product contaminated with bacteria is infused into a patient.
2. Air embolus, however incidence is low, because of alarm that sound when air is in the IV line. ( air-in-line alarms)
3. Bleeding aorund site when catheter is removed.
4. Allergic reaction is more severe than another route since with parenteral it cannot be retrieved.
5. Incompatibilities cause drug precipitation, inactivation, or adherence to container
6. Extravasation when catheter punctures and exits the vein under the skin, causing drugs to infuse or infiltrate into the tissue.
7. Particulate matter
8. Pyrogens cause fever and chills if injected in large enough amounts.
9. Phlebitis results in pain/discomfortand red streaking.

Question 13

What is the most
common source of IV related contamination?

Answer 13

Human touch contamination

Question 14

How much air given quickly does it take to cause harm?
Compare adults vs Infants.

Answer 14

in adults: 150 or 200 mL of air

infants or pediatric patients: much less

Question 15

Examples of particulate matter that are present in parenteral products.

Answer 15

• microscopic glass fragments
• hair
• lint or cotton fibers
• cardboard fragments
• undissolved drug particles
• fragments of rubber stoppers

Question 16

What are pyrogens?

Answer 16

the by-products or remnants of bacteria.

Question 17

What is phlebitis?
What causes phlebitis?

Answer 17

Irritation of the vein.
1. chemical/ physical properties of drug
2. location of the IV site
3. fast rate of administration
4. presence of particulate matter

Question 18

What is the main element of focus of Aseptic Preparation of Parenteral Products

Answer 18

on the development and maintenance of

1. good aseptic technique in the personnel
2. sterile compounding area
3. skills needed to use a laminar flood hood (LAH).

Question 19

What are the most important factors in preventing the contamination of sterile products.

Answer 19

1. Proper use of a LAH
2. strict aseptic technique

Question 20

Charcateristics of a Sterile Compounding Area

Answer 20

1. cleaned daily
2. segregated from normal pharmacy operations
3. Class 100 environment, which contains no more than 100 particles per cubic foot that are 0.5 micron or larger in size.
4. LAHs used to achieve a Class 100 environment.

Question 21

What is the Underlying principle of LAHs?
What are the types of LAH?
Which type is used to prepare antineoplastic/ anticancer drugs?

Answer 21

twice-filtered layers of aseptic air continuously sweep the work area inside the hood to prevent the entry of contaminated room air.

Horizontal (sweeps filtered air from the back of the hood to the front)
Vertical (air emerges from the top and passes downward through the work area)

Vertical is used because risk of exposure to airborne drug particulates is minimized.
referred to as biological safety cabinets (BSCs)

Question 22

What does HEPA stand for?
What % and size of particles does it remove?

Answer 22

high efficiency particulate air
removes 99.9% of particles that are 0.3 micron or larger.

Question 23

Characteristics and criteria for LAH.

Answer 23

1. nothing should pass behind a sterile object in a horizontal flow hood or above a sterile object in a vertical flow hood.
2. Materials disturb patterned flow of air. This “zone of turbulence” created behind an object could potentially extend outside the hood pulling or allowing contaminated room air into the aseptic working area
3. work with objects at least six inches from the sides and front edge of the hood without blocking air vents, so that unobstructed airflow
4. interior working surfaces of the laminar flow hood should be cleaned with 70% isopropyl alcohol.
5. Cleaning from the HEPA filter toward the front of the LAH (in a horizontal LAH)

Question 24

What is The first component of good aseptic technique?

GARB

Answer 24

proper personal attire.

Clean scrub suits/ gowns
Hair and shoe covers
surgical masks and gloves

Question 25

What are all of these areas? Work bench area Buffer area Ante area

Answer 25

where compounding is completed clean room area immediately surrounding the work bench. Should not contain any drains or sinks. Space beyond the buffer area for hand sanitizing, gowning, hands free faucets, air dryers, low-shedding towels, Supplies are unpacked and disinfected.

Question 26

Equipment and Supplies. 1. Syringes

Answer 26

* most drugs are more stable in glass * barrel and plunger (do not touch plunger) * Leur-lock at tip secures needle * sizes ranging from 0.5 to 60 mL. * solution only take up ½ to 2/3 of capacity to avoids touch contamination * package opened in LAH (not ripped or torn) * Pre-filled Syringes for IV/IM are convenient and saves time for commonly used drugs

Question 27

Equipment and Supplies. 2. Needles

Answer 27

* Size described by gauge (diameter of its bore) and length (needle shaft ranges from 3/8 to 3 ½ inches.) * larger the gauge, smaller needle bore. * Hub (attached the needle to the syringe, color-coded) * Shaft * Bevel (the tip of the needle shaft is slanted to form a point) *Bevel tip (point of slant) *Bevel heel (opposite end of the slant). *some needles have built in filters

Question 28

Drug Additive Containers 3. Ampules

Answer 28

* glass * once broken becomes open-system containers * Before opening solution visible in the top portion (head) should be moved to the bottom (body) by swirling, tapping or inverting. * ampule neck is cleansed with an alcohol swab * medication withdrawn from the ampule with a regular needle and then the needle is changed to a filter needle before pushing drug out of the syringe.

Question 29

Drug Additive Containers 4. Vials

Answer 29

* glass or plastic container with a rubber stopper protected by an aluminum cover/flip-top cap * hold powders and liquids. * Stopper swabbed with 70% isopropyl alcohol and allowed to dry (disinfects and physically moves particles) * are closed-system containers * air pressure inside vial similar to room air * prevent the formation of a vacuum by injecting volume of air equal to the volume of fluid to be withdrawn or reconstitute powdered drugs by injecting desired volume of sterile water * equal volume of air must be removed to prevent a positive pressure from developing inside the vial. * Multiple-dose vials have preservative agent, to retard the growth of bacteria

Question 30

What are the steps in Preparation of Intravenous Admixtures?

Answer 30

1. Before compounding assemble all materials and visually inspect 2. disinfect all injection surfaces and allow them to dry 3. discard Syringes and uncapped needles in sharp containers 4. Never recap a needle. Lay the syringe horizontally and slide the cap onto the needle. Or place the syringe vertically and drop the cap onto the needle. 5. Properly label the IV

Question 31

What are the Administration Systems for Parenteral Products? Continuous Infusions vs Intermittent injections

Answer 31

1. Continuous Infusions are More effective and less toxic Basic fluid and electrolyte therapy Blood products Specific drugs that require tight administration control to minimize adverse effects 2. Intermittent Injections for medications that work better when infused at defined time intervals e.g. antibiotics and GIT ulcer drugs

Question 32

Types of systems for intermittent injections:

Answer 32

LVP used for intermittent injections (Commercially Available, additives and advantageous because they reduce handling and contamination Pharmacy Prepared meets specific needs of patients) Small Volume Parenterals/Piggyback Systems (< 100 mL, higher than the primary IV e.g LVP to enter first, back-check valve turned off to prevent entry to primary IV,

Question 33

Types of Syringe Systems for intermittent injections

Answer 33

1. Syringe Pumps (syringe pump and tubing set operated by a battery or a compressing spring. administer single dose or a 12-or 24-hour supply at preprogrammed intervals.) 2. Volume Control Chambers (minimal fluid given per dose, beneficial in fluid-restricted or pediatric patients) 3. Gravity Feed (air vent in tubing, fluid is pulled out by gravity, inexpensive, no special equipment) 4. Intravenous Push (injected directly into Y site in IV tubing and pushed into the patient quickly, con difficult to control the rate of drug delivery and adverse effects when given too quickly)

Question 34

USP 797 – New Standards for the three risk levels This is for microbial, physical and chemical contamination

Answer 34

1. Low Risk (class 100, sterile, single transfers, no more than 3 products) 2. Medium Risk (No Broad Spectrum antibacterial, aseptic, Multiple doses) 3. High Risk (Sterile products compounded from nonsterile ingredients/device, terminal sterilization,

Question 35

How do you classify products into the 3 risk levels?

Answer 35

- How they are prepared - How long they can be stored - whether they are prepared for a single patient or as part of a batch - whether they are from a sterile or non-sterile source.

Question 36

Risk level 1

Answer 36

Sterile products w/o preservatives for individual patients batch prepared with preservatives for multiple patients. sterile products transferred into a sterile container Storage time and administration should not exceed : 28 hours at room temperature 7 days under refrigeration 30 days if frozen.

Question 37

Risk Level II

Answer 37

- batch-prepared w/o preservatives for multiple patients. - require multiple sterile ingredients combined in a sterile container through a closed system transfer then subdivided into multiple parts. - Storage time and administration can exceed: 28 hours at room temperature 7 days under refrigeration 30 day frozen.

Question 38

Risk Level III

Answer 38

- compounded from nonsterile ingredients, containers/ equipment or prepared from sterile/ nonsterile ingredients in an open system. pharmacist responsible for ensuring compliance with the guidelines/standards Areas of the document that affect the technician include training, policies and procedures, garb, aseptic technique, process validation, and end-product evaluation.

Question 39

What is Process Validation? What is process simulation?

Answer 39

procedures that ensure that the processes used in sterile product preparation consistently result in sterile products of acceptable quality. (incubate growth medium with sterile product and look for microbial growth) Validation may be accomplished through process simulation. Process simulation is carried out just like a normal sterile product preparation process except that a microbial growth medium is substituted for the products that would normally be used.

Question 40

What is End-Product Evaluation?

Answer 40

final inspection made by the pharmacist before the product is allowed to leave the pharmacy for leaks, cloudiness, particulate matter, color, solution volume, and container integrity, correct ingredients and quantities