Aseptics Flashcards
What does the term aseptic mean
free form contaminating organisms
what is aseptic technique
procedure used by medical staff to prevent the spread of infection. Used for manipulations of compounded sterile products and parental preparations that prevents contamination
what does enteral mean
relating to the intestines
what does parenteral mean
introduced other than by way of the intestine
in what dosage form is there increased risk to a patient
injection medicines that are prepared in clinical areas
in what patients are medicines sterilized
immunocompromised
hospitalised patients
inpatients on longer treatments
what is the max expirary of a aseptic medicine from section 10
7 days
what does the GMP state
products must be
consistent high quality
be appropriate for their intended use
meet the requirements of the marketing authorisation or product specification
what are the 2 main forms of contamination
viable
non viable
what is contained as a part of viable contamination
bacteria
fungi
viruses
toxins
what is contained as a part of non viable contamination
particulate
chemical
what is contamination
any effect or action that has a negative impact on product’s integrity making it unfit for use
what does a laminar flow cabinet do
provide a unidrectional stream of filtered air
what are the two types of laminar flow cabinets
horizontal
vertical
when is a horizontal laminar flow cabinet used
dispensing non hazardous products
when is a vertical laminar flow cabinet used
products which are hazardous to the operator
what are the 4 classes of clean zones
A - High risk operations
B - Background environments for Zone A
C&D - Clean zones for less controlled stages of manufacturing
What does IMS affect
Bacteria - good
Fungi - Fair
Viruses - good
Spores - None
what does Klercide A
Bacteria - good
Fungi - Fair
Viruses - Fair
Spores - None
What does Klercide B
Bacteria - good
Fungi - Fair
Viruses - Good
Spores - Good
what are the three types of environmental testing
Physical tests
Microbiological tests
Chemical tests
what are 3 examples of physical tests
status of rooms
glove leak tests
particle count
what are 3 examples of microbiological tests
settle plates
contact plate
swabs
what are 2 examples of chemical tests
surface swabs for chemical residues
surface wipes for chemical residues