Contamination of medicinal products

Question 1

what is the required sterility of medicinal products of oral, rectal, topical and inhaled

Answer 1

Non sterile but there’s a limit number of contaminants,

Question 2

what about Ophthalmic and Parenteral

Answer 2

Sterile

Question 3

What does sterility acceptance of medicinal products depend on?

Answer 3

Aqueous/ non aqueous
use of product: hazard can vary according to route
NATURE OF PRODUCT: it may support microbial growth, presence of preservatives,
Presence of disease, wounds, organ damage
Intended recipient; risk differs for e.g. neonates

Question 4

resistance to sterilising agents from least resistant to most resistant

Answer 4

Multi cellular organisms

Vegtiative bacteria and fungi, algae, protozoa, fungal spores, small viruses, Bacterial endospores, Prions

Question 5

What are the properties of Bacteria?

Answer 5

No membrane enclosed organelles
size ranging from 0.5-5um
Broadly divided into gram positive and gram negative bacteria
Most bacteria are non pathogenic,

Question 6

Why are bio films medically relevant? (or problem)

Answer 6

they tolerant to antibiotic
More tolerant to biocides (Including bleach)
More difficult to phagocyte, difficult to clear by the immune system

Question 7

What is bacterial sporulation?

Answer 7

The formation of spores, division into many spores , it is a survival strategy when nutrients become exhausted, mechanism used by some Gram positive bacteria,
spores are very resistant to heat, radiation, chemical agents
Can survive for many years

Question 8

When does sporulation occurs?

Answer 8

Happens at Stationary phase (when there’s no growth)

Question 9

What are the two types of fungi

Answer 9

Yeast (single cells, mostly reproduce by budding or fission but can form spores_
Mould; grow as masses of overlapping and interlinking hyphal filaments
reproduce by formation of spores