Aseptics Flashcards

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1
Q

What does the term aseptic mean

A

free form contaminating organisms

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2
Q

what is aseptic technique

A

procedure used by medical staff to prevent the spread of infection. Used for manipulations of compounded sterile products and parental preparations that prevents contamination

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3
Q

what does enteral mean

A

relating to the intestines

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4
Q

what does parenteral mean

A

introduced other than by way of the intestine

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5
Q

in what dosage form is there increased risk to a patient

A

injection medicines that are prepared in clinical areas

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6
Q

in what patients are medicines sterilized

A

immunocompromised

hospitalised patients

inpatients on longer treatments

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7
Q

what is the max expirary of a aseptic medicine from section 10

A

7 days

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8
Q

what does the GMP state

A

products must be

consistent high quality

be appropriate for their intended use

meet the requirements of the marketing authorisation or product specification

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9
Q

what are the 2 main forms of contamination

A

viable

non viable

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10
Q

what is contained as a part of viable contamination

A

bacteria
fungi
viruses
toxins

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11
Q

what is contained as a part of non viable contamination

A

particulate

chemical

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12
Q

what is contamination

A

any effect or action that has a negative impact on product’s integrity making it unfit for use

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13
Q

what does a laminar flow cabinet do

A

provide a unidrectional stream of filtered air

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14
Q

what are the two types of laminar flow cabinets

A

horizontal

vertical

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15
Q

when is a horizontal laminar flow cabinet used

A

dispensing non hazardous products

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16
Q

when is a vertical laminar flow cabinet used

A

products which are hazardous to the operator

17
Q

what are the 4 classes of clean zones

A

A - High risk operations
B - Background environments for Zone A
C&D - Clean zones for less controlled stages of manufacturing

18
Q

What does IMS affect

A

Bacteria - good
Fungi - Fair
Viruses - good
Spores - None

19
Q

what does Klercide A

A

Bacteria - good
Fungi - Fair
Viruses - Fair
Spores - None

20
Q

What does Klercide B

A

Bacteria - good
Fungi - Fair
Viruses - Good
Spores - Good

21
Q

what are the three types of environmental testing

A

Physical tests

Microbiological tests

Chemical tests

22
Q

what are 3 examples of physical tests

A

status of rooms
glove leak tests
particle count

23
Q

what are 3 examples of microbiological tests

A

settle plates
contact plate
swabs

24
Q

what are 2 examples of chemical tests

A

surface swabs for chemical residues

surface wipes for chemical residues