Sterilisation Processing

Question 1

What are the 2 general approaches for sterilisation?

Answer 1

1. Produce under ‘CLEAN’ conditions, then terminally sterilise in the final container
2. Produce and assemble under conditions FREE of microorganisms and other particulates (ASEPTIC PROCESSING) – more prone to contamination, not as reliable

Question 2

Which sterilisation option is preferred by manufacturers?

Answer 2

Option 1 - producing under clean conditions, more reliable

Question 3

What are the microbial contaminants within the manufacturing environment?

Answer 3

Raw materials
Water
Manufacturing environment

Question 4

What are raw materials?

Answer 4

• Synthetic/semi-synthetic (low levels of microorganisms)

- Natural - own intrinsic flora, greater levels of microorganisms

Question 5

What is the primary requirement for microbial growth?

Answer 5

Water - prone to microbial contamination

Question 6

What is included in the manufacturing environment?

Answer 6

• Air (acts as a vector)
• Personnel
• Equipment and facilities

Question 7

What are the sources of resident organisms?

Answer 7

• Soil (gram positive)
• Water (gram negative)
• Animals and humans - gram+ve/-ve
• Plants - yeasts and moulds

Question 8

What are the sources of transient organisms?

Answer 8

Carried by water and air (vectors)

Question 9

What is the definition of sterile?

Answer 9

free of viable microorganisms (absolute term – either sterile or contaminated, can’t use ‘quite sterile’)

Question 10

What is the definition of sterilisation?

Answer 10

process by which we eliminate – killing or removal of all viable microorganisms

Question 11

What are the methods for ‘killing’ sterilisation ?

Answer 11

o Moist heat sterilisation (safest, easiest and most reliable) – in presence of steam, excess of 100 degrees
o Dry heat sterilisation – in oven, absence of moisture for materials denatured by moisture
o Radiation sterilisation – cobalt 60 used for heat sensitive products
o Chemical – ethylene oxide sterilisation

Question 12

What is a method of ‘removal’ sterilisation?

Answer 12

Filtration – choose porosity carefully to remove cells

Question 13

What are sterilisation standards?

Answer 13

• Control the number of microorganisms in the manufacturing environment – guidance
• Validate sterilising agent – experimental data that shows effectiveness (e.g. of heat)
• Validate sterilisation process
• Monitor sterilisation process
• Regulated by: EN, FDA etc