Fundamentals of Sterile Preparations Flashcards
(101 cards)
1
Q
Definition of Sterility
A
freedom from bacteria and other microorganisms
2
Q
3 Requirements for asepsis
A
- Technique 2. Equipment 3. Environment
3
Q
What is a sterile compounding area:
A
room designated for compounding that meets specific cleanliness and air quality standards as defined in USP 797
4
Q
What is an engineering control?
A
controlled air environments
5
Q
definition of Engineering control:
A
designed to prevent, reduce and control potential nonviable and viable contaminants fro being introduced into CSP
6
Q
Viable
A
microorganism
7
Q
non-viable
A
do not contain living organism. serve s a transporter for viable particles
8
Q
Guiding principle of engineering controls:
A
cleaner air: reduces risk of contamination during compounding
9
Q
HEPA filters remove_____ of airborne particles and microorganisms of _____ micron
A
99.97% of airborne particles
greater than or equal to 0.3 micron
10
Q
Air exiting the HEPA filter is________
A
first air=air that touches critical sites
11
Q
In vertical airflow airflow is directed_______
A
downward and away from the operator
12
Q
In horizontal airflow airflow is directed_______
A
forward, preparation is protected, operator is not
13
Q
What are the two PEC
A
conventional, Isolators
14
Q
What conventional PEC would you use to prepare a non-hazardous CSP
A
LAFW, horizontal or verticle
15
Q
What conventional PEC would you use to prepare a hazardous CSP
A
biological safety cabinet (BSC) always vertical
16
Q
What isolator would usue use for a non-hazardous CSP
A
compounding aseptic isolator either turbulent or vertical airflow
17
Q
What isolator would you use for a hazardous CSP
A
A compounding aseptic containment isolator (CACI)
18
Q
IF PEC is turned off it needs to run ____ min prior to compounding
A
30 min
19
Q
T/F: only objects essential to compounding should be placed within the LAFW
A
T
20
Q
What are the TWO functions of PEC?
A
- filter bacteria and exogenous materials from air
2. maintain constant airflow out of workbench to prevent contaminated room air form entering the workbench
21
Q
What are 2 secondary Engineering Controls;
A
Cleanroom (Buffer area) Anteroom
22
Q
Cleanroom ______ supply airflow
A
HEPA filtered
23
Q
Cleanroom ISO class _____ air quality
A
7
24
Q
How many air changes per hour take place in clean room
A
30 or more
25
Temperature of a cleanroom
68 degress or 20 C; or cooler, logged daily
26
Requirements for cleanroom
access should be restricted to only compounding personnel
physically separate from other locations
all supplies need to be disinfected prior to entering
27
Cleanroom environment:
all furniture equipment and supplies shall be essential, non permeable, non shedding, cleanable, and resistant to disinfectants
-floors overlaid with wide sheet vinyl flooring with heat-welded seams and coving to the sidewall
no sources of water
-ceilings, walls, floors, fixtures-smmoth, impervious and non-shedding
28
Anteroom ISO class ____ or _____
7 or 8
29
Activities in Cleanroom
- supply equipment, and personnel decontamination
- hand hygiene and garbing procedures
- staging, unpacking clean room supply packages * no cardboard in clean room
- order entry
- csplabeling, and other high particulate generating activities
- all items should be disinfected in anteroom prior to entering clean room
30
What is a positive pressure room
- a room at higher pressure than the adjacent spaces
- prevent contaminants from entering critical areas
- used fro non-hazardous preparations
31
what is a negative pressure room
-a room at lower pressure than the adjacent space
protects the compounder and the environment
-used from hazardous preparations
32
What type of pressure should you use for hazardous preparations?
negative
33
LAFW USP requirments
ISO class 5. Positive air pressure. must be located with an ISO class 7 area. could be vertical or horizontal airflow
34
CAI
ISO class 5. positive air pressure. May be located outside an ISO 7 area if the CAI manufacturer provides written documentation based on validated environmental testing
35
BSC
ISO class 5. negative air pressure must be located within a separate ISO 7 area
36
CACI
ISO class 5. negative air pressure may be located outside an ISO 7 area if the CAI manufacturer pervades written documentation based on validated environmental testing.
37
Buffer Area ISO____
7
38
Ante area ISO _____ if opens into buffer area for non-hazardous CSP. ISO_____ if opens into buffer area used for compounding hazardous CSP
8, 7
39
How to clean Compounding area?
1. first with detergent
| 2. followed by disinfecting with sterile 70% IPA
40
Sterile 70% IPA:
- destorys and removes microbes
- prevent entry to the compounding area
- eliminate and prevent accumulation of pyrogens
41
How often should floors, counters, and worked areas be cleaned ?
daily
42
how often should shelving, walls, and ceilings be cleaned?
monthly
43
when should surfaces/PEC be cleaned?
at the beginning of each work shift
before each batch
every 30 min during compounding
during heavy surface contamination
44
define Aseptic Technique:
Methods used to manipulate sterile products so they remain sterile.
45
2 important things in the concept of first air:
HEPA filtered air washes over the products in the compounding work area
must maintain a direct path of first air between the HEPA filter and the critical site manipulations/sterile objects
46
Define Critical Site
location that includes any component or fluid pathway surface or openings exposed and at risk of direct contact with air, moisture, or touch contamination
47
Examples of critical sites:
```
every part of needle except cap
syringe hub
syringe plunger
vials rubber closure ( once punctured )
ampule neck
additive port
drug
```
48
Horizontal workbench: never allow anything to pass ___ the critical sites of the sterile object
behind
49
Vertical workbench: never allow anything to pass ____ the critical sites of the sterile object
above
50
Zone of Turbulence definition
air turbulence created inside the critical area by the introduction of an object in the direct path of first air
51
manipulate and place products at least ___ in from the front edge AND sides of the workbench and ___ from the back of hood
6, 3
52
Things to remember in vertical airflow
avoid blockage of air intake vents on work surface of hood
work above grills
compound 3 in above the work surface
keep the vial/syringe setup horizontal as opposed to vertical
hold syringe from the bottom side
53
What is a bolus/push:
syringes containing drug; given over short amount of time
54
iv infusion:
introduction of larger volumes of solution directly into a vein
55
small-volume parenterals
drug in isotonic IV solution
volume less than or equal to 100 mL
typically intermittent IV medications
56
Large-volume parenterals
volume more than 100 mL topically continuous, titratable Iv medications, but many SVPS are also intermittent products as well.
57
Advantage of pre made parenteral preparations (3)
- quick
- convenient
- less prone to error or contamination
58
Disadvantages of pre made parenteral preparations 2
- usually significantly more expensive
| - product may not be stable for prolonged expiration or may not meet the needs of all patients
59
what is a ready to mix system?
specially designed IV bag with adapter for attaching a powder drug vial. admixing takes place inside bag just prior to administration
60
Advantages of RTM systems (2)
significant reduction in waste and compounding time
| drug vial can be rechecked by nursing
61
Disadvantages of RTM systems (4)
more costly
- need to give full vial
- not all products available for this system
- potential of not activating properly
62
What are the two ports on an IV bag
-administration set port
| = medication port
63
Define adminstration set port:
- spike of administration set inserted here
- plastic cover to maintain sterility
- plastic diaphragm prevents leaking
64
Define Medicaiton port;
used to add medications
covered by a protective rubber tip
inner plastic diaphragm - 1/2 in inside the port, needle must be long enough to punter both diaphragms.
protective outer ubber tip prevents leaking
65
When to remove liquid from IV bag?
when correct concentration matters
| when drug volume is so large that IV bag could not hold additional volume
66
Requirements for reconstituting a drug 5
always review package insert regarding solvent and BUD
- inject fluid slowly into the vial to prevent foaming
- rotate vial for dissolution
- immediately label reconstituted vial with date and time, if not disposing of immediately
- always need to consider PV
67
Define Powder Volume
space occupied by powder of reconstituted drug-constant strength per vial size
68
4 container requirements:
1. must be sterile, free of particulate matter and pyrogens
2 should not interact physically or chemically w formulations to alter their required strength, quality, or purity
3. slightly overfilled to allow withdrawal of the full dose
69
Glass container
most popular material
| less reaction between drug and container
70
plastic container
plastic polymer may cause:
permeation of vapors and other molecules in either direction through the container
leaching of the constituents from the plastic into the preparation
adsorption of drug molecules onto the plastic
less costly
71
vial closures:
must be sterile, free from pyrogens, and surface particles
typically made of rubber
stopper selection is critical pharmaceutical industry
subject to coring
72
Define vial coring:
occurs when needle puncture tears a piece of the rubber closure and the piece then falls into the container
if concerns, filter or discard
73
ampules____ filter
always
74
Define needle deadspace:
fluid retained in needle after plunger depressed completely
75
When to consider needle dead space:
1. volume <3 mL
76
define priming volume
when a precise dose is needed, extra drug volume is added to accommodate volume lost to dead space in needle
77
process of Priming volume in compounding:
pull up additional 0.1 mL of drug, remove needle/attache new needle
prime to correct volume
inject into the bag
78
Who is responsible for proper storage of CSP?
compounding personnel
79
room temperature
20-25
80
cold temperature
2-8
81
freezing temperature
-10- -25
82
Beyond Use Date is based on :
1. active ingredient chemical stability
| 2. sterility limitation for the risk level per USP 797 recommendations
83
Stability of ingredients:
max time period in which more than or equal to 905 of active ingredient is measurable in the solution and container specified under the stated storage and administration conditions form manufacturer
84
High risk sterile compounding:
manipulating equipment and/or ingredients that are NOT sterile but will be eventually sterilized
strile ingredients, devices, and containers are exposed for more than 1 hour outside of ISO5 air
non sterile water ingredients are stored for more than 6 hours prior to terminal sterilization
85
Low and medium risk sterile compounding:
manipulating commercially available components that are already sterile
86
storage requirements for low risk CSP
room 48, refrigeration 14 days freezer 45 days
87
what makes a CSP low risk
compounding occurs within the PEC
compounding w no more than 3 sterile ingredients
compounded using closed or sealed systems
using only simple manipulations
88
what makes a CSP medium risk
compounding occurs within the PEC
compounding with more than 3 sterile ingredients
complex aseptic manipulations
used for multiple patients
used for one patient on multiple occasions
89
storage requirements for Medium risk CSP
30 hours 9 days 45 days
90
storage requirements for medium risk CSP
24 hours 3 days 45 days
91
High risk CSP must undergo sterilization by filtration with a ____ micron filter in _____
0.2 PEC
92
Intermediate use CSP:
intended for immediate adminstration
93
requirements for immediate use CSP:
involves simple transfer manipulations (low risk)
compounding procedure <1 hr after intimation of the compounding process
CSP discard if administration does not begin 1 hr after the intimation of compounding
Properly labeled, names and amounts of all ingredients, initials of compoungind personnel, patient id info, exact one hr BUD and time
94
single dose container:
sterile drug intended for administration as a single dose; and which when opened cannot be re-sealed with assurance that sterility has been maintained
95
multiple dose container:
sterile drug intended for withdrawal of successive portions of its contents from the container without changing the strength, quality, or purity of the remaining portion
96
single dose vials can be stored in PEC for _____
6 hrs
97
single dose vials can be stored outside PEC for ____
1 hr
98
opened ampules must be stored for ____ period of time
NO
99
multiple dose containers may be used for ___ days after initial needle puncture or unless otherwise specified by the manufacturer
28 days q1
100
purpose of a procedure
for another to be able to replicate your work
101
why do we document?
prepare consistent product
prevent error
provide traceable record
