Sterility testing Flashcards
Sterility is the
complete absence of life
Are there any degrees of sterility?
no
Parental drug delivery systems and many medicine products must be sterile (to avoid _______ degradation or _______ occurring as a result of their use
microbial
infection
Sterility is important for materials or instruments that are likely to contact _____ ____ or internal ______.
broken skin
organs
What are some sterile products?
- injections
- ophthalmic preparations
- dialysis solutions
- certain surgical dressings
- implants
- surgical instruments (rubber gloves, scalpel and scissors, needles, catheter etc
Sterile products must be free of _____ microorganisms. Absence of ______ is desired but difficult to demonstrate. Products should be manufactured in a manner that reduces to the _______ likelihood the risk of microbial contamination
viable
prions
lowest
Terminal sterilisation involves making the product under _______________ conditions using ________ ingredients. This is then _______ at the end of the process.
non sterile
non sterile
sterilised
Aseptic manufacturing involves making the product under ______ conditions using _______ ingredients
sterile
sterile
Sterilisation processes concentrate on the ______ or physical ______ of all microorganisms in the product. Processes are designed to remove the most _______ microorganisms. Why/ What is the principle?
destruction
removal
problematic/ resistant
The principle is that the removal of the most problematic species will have led to the elimination of the less resistant microorganisms.
The choice of sterilisation is determined largely on:
For example, it may depend on the t_____stability of the product
the ability of the product to withstand the physical stresses applied during the process.
thermostability
The success of the process depends upon a suitable choice of treatment conditions. These are
the temperature and duration of exposure.
Overkill is achieved by what conditions?
121 degrees for 15 mins at 15 psi
If it is not possible to use moist heat ( if product is NOT thermostable) what can you do? Give an example of ONE alternative
Use alternative methods.
Filtration in combination with aseptic processing
Is aseptic processing a method of sterilisation?
No its just a method of preventing contamination
Which shows greater sensitivity to sterilisation? Small viruses or large viruses?
Large
Suitable reference organisms for testing sterilisation efficacy are the most durable….
bacterial SPORES
What bacterial spore is used for moist heat?
Geobacillus stearothermophilus
What bacterial spore is used for dry heat and gas sterilisation?
Bacillus subtilis or Bacilus atrophaeus
What bacterial spore is used for ionising radiation?
Bacillus pumilus
When exposed to a killing process, microbial populations generally lose their viability in an insert mathematical function fashion
exponential
DO THE CALCULATIONS
UNDERSTAND THEM
A sterility assurance level of _____ is necessary. So, for an initial bioburden of 10^2, and IF of ____ is needed. This means that the product will require __ times the exposure of the D value of the organism
10^-6 spores/ml
10^8
8
Back in the day, quality control of sterile products consisted largely of _____ tests. However, these are limited in terms of
sterility
their ability to detect low concentrations of microorganisms
NOW, quality control of sterile products is assured by combining process monitoring and performance criteria including:
- bioburden determinations
- environmental monitoring
- validation and monitoring of sterilisation procedures
- sterility testing
