Validation and Monitoring

Question 1

Validation = demonstrating

Answer 1

that a procedure will consistently result in the same outcome.

Question 2

As sterility CANNOT BE GURANTEED, it must be ASSURED by application of fully ______ processes. Both the _______ process and it’s effect on the outcome should be validated. Re-validation is required when any ______ to a procedure is made.

Answer 2

validated
sterilisation
changes

Question 3

Parametric release is defined as

Answer 3

the release of a product based on compliance to the physical specifications and validated procedures, rather than sterility testing.

Question 4

Parametric release can only be applied to products that are _____ sterilised in their final containers

Answer 4

terminally

Question 5

The goals of validation are to demonstrate:

Answer 5

• suitability of process
• uniformity of process
• reproducibility of process

Question 6

Requirements for product release include:

Answer 6

• Documented procedures for product handling have been followed.
• The process conforms to sterilisation specification.
• Facilities correctly maintained, routinely checked, process validated and equipment tests performed according to documented procedures.
• Load and packaging have not been damaged by processing or transportation.
• Automatic sterilisation cycles were performed to a satisfactory standard.
• Chemical indicators have shown a satisfactory outcome.
• All sterilisation cycles were correctly and completely documented.

Question 7

TRUE or FALSE

Chemical indicators provide indication of microbial killing

Answer 7

FALSE.
Convenient to use but do NOT provide any indication of microbial killing. Rather, they are based on the ability of steam, heat, gases and ionising radiation to alter the properties of the indicator when satisfactory conditions are met.

Question 8

TRUE or FALSE

All chemical indicators integrate a number of parameters

Answer 8

FALSE

Some integrate a number of parameters, some indicate only one parameter

Question 9

Name some chemical indicators

Answer 9

Browne’s Tubes (temp + time)
TST (cycle verification)
Thermalog

Question 10

What resistant organism is used as a biological indicator for 0.45um membrane filtration?
a) Geobacillus stearothermophilus
b )Brevundimonas (Pseudomonas) diminuta 
c) Serratia marcescens
d) Bacillus atrophaeus
e) Bacillus pumilus

Answer 10

Serratia marcescens