Sterility testing

Question 1

Sterility is the

Answer 1

complete absence of life

Question 2

Are there any degrees of sterility?

Answer 2

no

Question 3

Parental drug delivery systems and many medicine products must be sterile (to avoid _______ degradation or _______ occurring as a result of their use

Answer 3

microbial

infection

Question 4

Sterility is important for materials or instruments that are likely to contact _____ ____ or internal ______.

Answer 4

broken skin

organs

Question 5

What are some sterile products?

Answer 5

• injections
• ophthalmic preparations
• dialysis solutions
• certain surgical dressings
• implants
• surgical instruments (rubber gloves, scalpel and scissors, needles, catheter etc

Question 6

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

Answer 6

viable
prions
lowest

Question 7

Terminal sterilisation involves making the product under _______________ conditions using ________ ingredients. This is then _______ at the end of the process.

Answer 7

non sterile
non sterile
sterilised

Question 8

Aseptic manufacturing involves making the product under ______ conditions using _______ ingredients

Answer 8

sterile

sterile

Question 9

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?

Answer 9

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.

Question 10

The choice of sterilisation is determined largely on:

For example, it may depend on the t_____stability of the product

Answer 10

the ability of the product to withstand the physical stresses applied during the process.
thermostability

Question 11

The success of the process depends upon a suitable choice of treatment conditions. These are

Answer 11

the temperature and duration of exposure.

Question 12

Overkill is achieved by what conditions?

Answer 12

121 degrees for 15 mins at 15 psi

Question 13

If it is not possible to use moist heat ( if product is NOT thermostable) what can you do? Give an example of ONE alternative

Answer 13

Use alternative methods.

Filtration in combination with aseptic processing

Question 14

Is aseptic processing a method of sterilisation?

Answer 14

No its just a method of preventing contamination

Question 15

Which shows greater sensitivity to sterilisation? Small viruses or large viruses?

Answer 15

Large

Question 16

Suitable reference organisms for testing sterilisation efficacy are the most durable….

Answer 16

bacterial SPORES

Question 17

What bacterial spore is used for moist heat?

Answer 17

Geobacillus stearothermophilus

Question 18

What bacterial spore is used for dry heat and gas sterilisation?

Answer 18

Bacillus subtilis or Bacilus atrophaeus

Question 19

What bacterial spore is used for ionising radiation?

Answer 19

Bacillus pumilus

Question 20

When exposed to a killing process, microbial populations generally lose their viability in an insert mathematical function fashion

Answer 20

exponential

Question 21

DO THE CALCULATIONS

Answer 21

UNDERSTAND THEM

Question 22

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

Answer 22

10^-6 spores/ml
10^8
8

Question 23

Back in the day, quality control of sterile products consisted largely of _____ tests. However, these are limited in terms of

Answer 23

sterility

their ability to detect low concentrations of microorganisms

Question 24

NOW, quality control of sterile products is assured by combining process monitoring and performance criteria including:

Answer 24

• bioburden determinations
• environmental monitoring
• validation and monitoring of sterilisation procedures
• sterility testing

Question 25

SAL achieve depends on both the pre sterilisation _______ and the design of the __________ process

Answer 25

bioburden

sterilisation

Question 26

Low pre-sterilisation bioburden is ideal as it means:

Answer 26

• less exposure to sterilisation temperatures
• shorter autoclaving cycles use less energy (more autoclave runs/ day)
• greater chance of product passing bacterial endotoxin test (BET)

Question 27

Where an antimicrobial comprises or forms part of the product, it must be inactivated during sterility testing. How can this be achieved?

Answer 27

• dilution (to a level where it ceases to have any activity)
• specific inactivation (neutralising agent)
• membrane filtration