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compounding > Lecture 1: sterile compounding > Flashcards

Lecture 1: sterile compounding Flashcards

1
Q

Sterility definition

A

Complete absence of viable microorganisms
- can only be demonstrated by destructive testing for all compounded preparations

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2
Q

Compounded sterile preparations (CSP)

A

preparation intended to be sterile
created by combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering product/bulk drug substance
(USP 797)

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3
Q

What are some ways sterile preps may become contaminated?

A

Nonsterile ingredients
Process water
Packaging components
Process equipment
Compounding personnel

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4
Q

What is the purpose of sterile medications?

A

When route of admin bypasses the body’s natural defense mechanism s (parenteral)

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5
Q

Popular ROA for drug and vaccine administration

A

Subcutaneous
Intramuscular

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6
Q

Most common ROA for medications

A

Intravenous

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7
Q

Uncommon ROA for medication administration may obtain access for monitoring

A

Intraarterial

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8
Q

Common ROA for PPD and allergy test

A

Intradermal

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9
Q

ROA to inject into meninges of spinal cord

A

Intrathecal

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10
Q

ROA to inject into tissues surrounding spinal cord

A

Epidural

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11
Q

Other sterile routes of administration

A

Opthalamic (solution, susp, oint, inserts) + injections (intraocular/intravitreal)
Intranasal, inhalation
Some ointments (otic, vaginal)

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12
Q

Hand Hygiene

A

wash hands and forearms up to the elbows with soap + water before compounding

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13
Q

Things not to use in handwashing

A

No brushes
No hand dryers
Soap must be a closed system

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14
Q

Hand washing procedure

A
  1. remove visible debris from underneath fingernail under warm running water using a disposable nail cleaner
  2. wash hands and forearms up to the elbows w/ soap + water for at least 3 seconds
  3. dry hands and forearms to the elbows completely with low-lint disposable towels
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15
Q

Hand sanitizing

A

sanitize hands with alcohol based hand rub before donning sterile gloves
- must be donned in a classified room or segregated compounding area

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16
Q

Hand sanitizing procedure

A

enter segregated compounding area
1. apply alcohol to dry skin
2. rub hands together
3. allow hands to dry before donning gloves

17
Q

Gloves

A

Sterile, powder free
apply 70% IPA regularly & whenever nonsterile surfaces are touched (vials, counter tops, carts)

18
Q

Restricted access barrier system

A

Disposable gloves worn inside RABS glove and outside over the RABS
- Enclosure provides ISO class 5 air
- allows passage of materials through defined openings, generally not to be opened during operations

19
Q

Garbing requirements

A

Use low lint gown, shoe covers, head cover, face mask
Sterile powder free gloves

20
Q

Order of garbing must reduce the risk of contamination

A

Determined by facility, documented by SOPs
1. Donning/doffing in the ante-room
2. Replace if visibly soiled
3. may reuse within same shift if gown kept in classified area/SCA

21
Q

Air quality standards: ISO class

A

air quality classification from the international organization for Standardization (ISO)
Classified based on particulate matter in room air

22
Q

ISO class 5

A

Laminar airflow workbench
Cleanest

23
Q

ISO class 7

A

Buffer room (cleanroom)
(352,000 particles)

24
Q

ISO class 9

A

Ante-room
- for garbing

25
Q

The higher the ISO class #, the _____ the likelihood for contamination

A

higher

26
Q

Primary engineering controls

A

device or zone that provides ISO class 5
(LAWB, isolator, etc)

27
Q

Secondary engineering control

A

Larger area where PEC is located
Incorporates specific design and operational parameters required to minimize risk of contamination within the compounding area
(ISO 7 cleanroom)

28
Q

Laminar air flow system

A

a device OR zone within buffer area
- provides ISO class 5 or better air (ISO 4, 3)
- unidirectional HEPA filtered airflow

29
Q

a HEPA filter removes ______ of ALL particles 0.3 microns or larger

A

99.97%

30
Q

Particles that are 0.3 microns or larger include

A

dust
mold
pollen
bacteria

31
Q

Types of laminar airflow workbench

A

Horizontal
Vertical

32
Q

Most common LAFW for sterile compounding

A

Horizontal LAFW
air flows towards the compounder

33
Q

LAFW for hazardous drugs

A

Vertical LAFW (biological safety cabinet)
- protects the compounded

34
Q

Compounding aseptic isolator (CAI)

A

Type of RABS that uses HEPA filtration to provide ISO class 5 unidirectional air
- designed for sterile non-hazardous drugs

35
Q

Aseptic technique purpose

A

Workflow in primary engineering controls do not ensure sterility
must use procedures to minimize contamination

36
Q

Aseptic technique definition

A

The method and manipulations required to minimize the contamination of sterile compounded formulations

compounding (12 decks)

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