Exam 2 - Sterile preparations (technique) Flashcards
(22 cards)
List the methods of administration for IV injection
bolus (one shot)
infusion (constant rate over a period of time)
List the sites of administration for IV injection
peripheral vein
central vein (bringing solution directly into the heart)
List the infusion modes of administration for IV injection
continuous administration
intermittent administration
T/F: oil cannot be injected IV
false (it can be through aversion)
T/F: straight oil cannot be injected IV
true
List possible adverse effects that can be caused by inevitable blood vessel injury from IV injections
phlebitis
thrombosis
thrombophlebitis
Describe phlebitis
- inflammation from irritation of the tunica intima of the vein (near part of the blood vessel)
- moderate-severe discomfort
- may take days-months to subside
- limits veins available for future therapy
Describe thrombosis
- formation of a blood clot (thrombus) in the vein
- pain, swelling
- pulmonary embolism: blocks capillaries in body
Describe thrombophlebitis
inflammation of the vein associated with blood clots
Define “PEC”
“primary engineering control”
LAFW or BSC
Define “LAWF”
“laminar flow workbenches”
- a very clean environment but not sterile (not actively removing bacteria, needs to be combined with aseptic technique)
What is the role of LAFW?
- provides HEPA filtered, very clean air (ISO class 5)
- no more than 100 particles with a size of > 0.5 nm per ft3 (or 3, 520 particles/m3)
- so clean that it allows us to maintain sterility throughout the CSP, provided that we use proper aseptic technique
Describe a horizontal LAFW
clean air coming from front and flows to “me” (room for sloppiness)
typically easier to work with
Describe a vertical LAFW
- clean air coming from top and flow to bottom
- more difficult to deal with compared to horizontal
- must be used for hazardous (cytotoxic and vesicant) drugs
Describe “laminar flow”
- streamlines the flow of a fluid in which the fluid moves in layers without turbulence
- occurs at low air velocities (<100ft/min)
Describe aseptic technique as outlined in USP 797
- manipulation of materials in a way to avoid
- accidental introduction of microorganism
- proper personnel behavior
- proper handling of gloves, syringes, vials, needle, ampuls, etc
- ensure the sterility of the final product
Before compounding, what should be done by the pharmacist?
must be properly garbed and must maintain proper personal hygiene
(squamous cells are normally shed from the human body at a rate of 106 per hour)
Other than garbing and aseptic technique, list the remaining guidelines in USP 797
- documentation of the compounding process (e.g master formulation and compounding records)
- principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within ISO class 5 area
- proper use of PECs
- principles of movement of materials and personnel within the compounding area
Define “critical sites”
- a location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, and beakers) or openings (e.g., opened ampules and needle hubs) that are exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination
- any point where microorganisms or other contamination can enter a parenteral product during compounding
- ex. puncture site on a vial
Define “DCA”
“direct compounding area”
- a critical area within the ISO Class 5 PEC where critical sites are exposed to unidirectional HEPA-filtered air, aka first air (from source to critical site, there should be no interruption between)
- space between the HEPA filter and the critical site
- must keep uninterrupted laminar air flow in this area
Define the “first air principle”
making sure that the critical site is directly in contact with source of HEPA filtered clean air, keep the path between the air and critical site free
Define “first air”
The air exiting the HEPA filter in a unidirectional air stream
