Dry Heat Sterilisation

Question 1

True or False? (If false, correct the statement)

- Sterility is the absence of microorganisms

Answer 1

TRUE!

Question 2

True or False? (If false, correct the statement)

- Sterilisation is the partial removal or destruction of some living organisms

Answer 2

FALSE!

Sterilisation is the complete removal or destruction of all living organisms

Question 3

True or False? (If false, correct the statement)

- Sterility testing guarantees sterility

Answer 3

FALSE!

Sterility testing cannot guarantee sterility

Question 4

True or False? (If false, correct the statement)

- There is no specific sterility assurance level

Answer 4

FALSE!

Sterility Assurance level is (10^-6)

Question 5

True or False? (If false, correct the statement)

Sterilisation can be used at the end, instead of good manufacturing practices.

Answer 5

FALSE!

Sterilisation isn’t an alternative to good manufacturing practices!

Question 6

What is preferred, using aseptic technique and using sterile excipients OR terminal sterilisation? (sterilisation in the final container)

Answer 6

TERMINAL STERILISATION IS PREFERRED

Question 7

What are some items that require sterilisation?

Answer 7

• disposable gloves
• water ampoules for injection
• infusion packs
• dry powders
• oils
• delicate equipment
• thermolabile liquids
• wound dressings
• medical devices e.g catheters, syringes

Question 8

What are the five methods of sterilisation recommended by the BP?

Answer 8

• Steam sterilisation
• Dry sterilisation
• Gas sterilisation
• Ionising radiation
• Filtration

Question 9

State which products can be heat sterilised and whether it is moist heat or dry heat stabilised,

Answer 9

MUST BE THERMOSTABLE PRODUCTS!

• IF moisture resistant items, moist heat sterilisation.
• IF moisture sensitive items, dry heat sterilisation.

Question 10

Outline the conditions and characteristics of dry heat sterilisation.

• Action is through ______ process.
• SAL of:

Answer 10

• product must be thermostable
• must be moisture sensitive
• killing is less effective in absence of moisture
• PROCESS: heat up, sterilisation (holding time), cool down
• action through OXIDATIVE process
• SAL of 10^-6 or better!

Question 11

In a dry heat sterilisation process, a fan is present to:

Answer 11

circulate the air

Question 12

In a dry heat sterilisation process, a metal rack shelving is present to:

Answer 12

allow air movement

Question 13

Holding stage conditions can be:

Answer 13

• 160 degrees for 2 hours (ref)
• 170 degrees for 1 hour
• 180 degrees for half an hour

Question 14

What applications can you use dry heat sterilisation for?

Answer 14

• glassware (depyrogenation of)
• metal instruments
• non aqueous thermostable liquids
• thermostable solids