Aseptic Technique and Sterile Compounding of Intravenous Admixtures Flashcards
What does the term Aseptic technique refer to?
What is it designed to do?
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.
What are the responsibilities of compounding personnel?
- follow precise verbal/written directions
- calculate mathematical equations
- operate specialised equipment
- measurement and dilution
- labelling and dispensing
- use sterile equipment properly
CSPs must be free from________
living organisms
particles
pyrogens
bacterial toxins
Special CSPs include_______
CSPs stands for
High risk preparations
Hazardous drugs
Radiopharmaceuticals
Allergy extracts
Compounded sterile preparations
What is the role of sterile compounding in pharmacy?
- following precise steps to prevent infections, errors, and unsafe preparations.
- So you can distinguish if patient infection is due to disease or because of pharmacy error.
- to compound for animals and humans
List the type of parenteral dosage forms.
Which is the most common?
- Basic Intravenous Therapy (IV) (most common)
- intramuscular (IM)
- subcutaneous (SQ, SC)
- intradermal (ID)
- epidural
IV fluids come in LVP.
What is the volume?
What does it usually contain?
large-volume parenteral
more than 100 mL
usually a simple solution of dilute dextrose,
sodium chloride or both.
Characteristics of Basic IV Therapy
- Hang on an IV pole 36 inches higher than the patient’s bed.
- Solution is infused continually to keep blood from clotting in the catheter and plugging the line.
- Primary IV set attaches to the LVP.
common features of IV set: Drip chambers - Electronic infusion devices used in fluid restricted patients or when the LVP cannot be monitored by using the gravity method.
How are drip chambers in primary IV sets classified?
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
What does Secondary IV sets refer to?
Drugs that are routinely delivered through the same basic IV setup are usually attached to a “secondary IV set” connected to the primary set
What are the two types of catheters?
Describe them.
- 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 - 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.
What are the risks of Risks of Intravenous Therapy?
- Infection if product contaminated with bacteria is infused into a patient.
- Air embolus, however incidence is low, because of alarm that sound when air is in the IV line. ( air-in-line alarms)
- Bleeding aorund site when catheter is removed.
- Allergic reaction is more severe than another route since with parenteral it cannot be retrieved.
- Incompatibilities cause drug precipitation, inactivation, or adherence to container
- Extravasation when catheter punctures and exits the vein under the skin, causing drugs to infuse or infiltrate into the tissue.
- Particulate matter
- Pyrogens cause fever and chills if injected in large enough amounts.
- Phlebitis results in pain/discomfortand red streaking.
What is the most
common source of IV related contamination?
Human touch contamination
How much air given quickly does it take to cause harm?
Compare adults vs Infants.
in adults: 150 or 200 mL of air
infants or pediatric patients: much less
Examples of particulate matter that are present in parenteral products.
- microscopic glass fragments
- hair
- lint or cotton fibers
- cardboard fragments
- undissolved drug particles
- fragments of rubber stoppers
What are pyrogens?
the by-products or remnants of bacteria.
What is phlebitis?
What causes phlebitis?
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
What is the main element of focus of Aseptic Preparation of Parenteral Products
on the development and maintenance of
- good aseptic technique in the personnel
- sterile compounding area
- skills needed to use a laminar flood hood (LAH).
What are the most important factors in preventing the contamination of sterile products.
- Proper use of a LAH
- strict aseptic technique
Charcateristics of a Sterile Compounding Area
- cleaned daily
- segregated from normal pharmacy operations
- Class 100 environment, which contains no more than 100 particles per cubic foot that are 0.5 micron or larger in size.
- LAHs used to achieve a Class 100 environment.
What is the Underlying principle of LAHs?
What are the types of LAH?
Which type is used to prepare antineoplastic/ anticancer drugs?
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)
What does HEPA stand for?
What % and size of particles does it remove?
high efficiency particulate air
removes 99.9% of particles that are 0.3 micron or larger.
Characteristics and criteria for LAH.
- nothing should pass behind a sterile object in a horizontal flow hood or above a sterile object in a vertical flow hood.
- 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
- work with objects at least six inches from the sides and front edge of the hood without blocking air vents, so that unobstructed airflow
- interior working surfaces of the laminar flow hood should be cleaned with 70% isopropyl alcohol.
- Cleaning from the HEPA filter toward the front of the LAH (in a horizontal LAH)
What is The first component of good aseptic technique?
GARB
proper personal attire.
Clean scrub suits/ gowns
Hair and shoe covers
surgical masks and gloves
What are all of these areas?
Work bench area
Buffer area
Ante area
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.
Equipment and Supplies.
1. Syringes
- 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
Equipment and Supplies.
2. Needles
- 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
Drug Additive Containers
3. Ampules
- 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.
Drug Additive Containers
4. Vials
- 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
What are the steps in Preparation of Intravenous Admixtures?
- Before compounding assemble all materials and visually inspect
- disinfect all injection surfaces and allow them to dry
- discard Syringes and uncapped needles in sharp containers
- 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.
- Properly label the IV
What are the Administration Systems for Parenteral Products?
Continuous Infusions vs Intermittent injections
- 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 - Intermittent Injections for medications that work better when infused at defined time intervals e.g. antibiotics and GIT ulcer drugs
Types of systems for intermittent injections:
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,
Types of Syringe Systems for intermittent injections
- 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.) - Volume Control Chambers
(minimal fluid given per dose, beneficial in fluid-restricted or pediatric patients) - Gravity Feed
(air vent in tubing, fluid is pulled out by gravity, inexpensive, no special equipment) - 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)
USP 797 – New Standards for the three risk levels
This is for microbial, physical and chemical contamination
- Low Risk
(class 100, sterile, single transfers, no more than 3 products) - Medium Risk
(No Broad Spectrum antibacterial, aseptic, Multiple doses) - High Risk
(Sterile products compounded from
nonsterile ingredients/device, terminal
sterilization, <class 100 , not adequately preserved
How do you classify products into the 3 risk levels?
- 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.
Risk level 1
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.
Risk Level II
- 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.
Risk Level III
- 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.
What is Process Validation?
What is process simulation?
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.
What is End-Product Evaluation?
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
