sterile product

Question 1

what are the two general approaches of producing a sterile product?

Answer 1

1. ) Produce under ‘CLEAN’ conditions – > reduced number of microorganisms, then TERMINALLY sterilise in final container  chose the most appropriate way of sterilisation
2. ) Produce and assemble under conditions ‘FREE’ of microorganisms and other particulates

Question 2

what could cause microbial contamination within the manufacturing environment?

Answer 2

• raw materials
• water
• air
• personnel
• equipment

Question 3

what are the sources of microorganisms?

Answer 3

• Soil at some part of the extraction process
o Gram positive, endospore forming, fungi
• Water
o Gram negative, yeast and moulds
• Animals
o Gram negative, obligate anaerobes (mainly found in gut), gram positives
• Plants
o Yeasts & moulds
• Transient organisms
o Carried by water and air (two main vectors). Humans as operators can also act as vector

Question 4

what does sterile mean?

Answer 4

free of viable microorganisms

Question 5

what is sterilisation?

Answer 5

killing of removal of all viable microorganisms

Question 6

what are the two traditional methods of sterilisation?

Answer 6

• killing

- removal

Question 7

what are the types of killing method?

Answer 7

• moist heat steam (autoclaving)
• dry heat sterilisation (absence of moisture)
• radiation
• chemical

Question 8

what is the type of removal method?

Answer 8

filtration - need to take porosity into consideration

Question 9

what are the sterilisation methods used for?

Answer 9

• Control numbers of microorganisms in manufacturing - guidance for any standards which guide the manufacturer in the best process
• Validate sterilising agent - experimental data which shows what is required to kill certain microorganisms
• Validate sterilisation process
• Monitor sterilisation process - what controls have been put in place for this process