Introduction to Sterilisation

Question 1

what are the 2 ways the microbiological quality of pharmaceutical products is controlled

Answer 1

1. controlling the types of microorganisms present
   - non sterile products
2. controlling the number of microorganisms present
   - some present: non sterile products
   - non present: sterile present

Question 2

define sterile product

Answer 2

completely free viable microbial contaminants

Question 3

what is sterility

Answer 3

absence of microorganisms

Question 4

define sterilisation

Answer 4

complete removal or destruction of all living organisms

Question 5

does sterility testing guarantee sterility

Answer 5

cannot guarantee sterility
- must use validated processes and sterility assurance level (10^-6)
- sterility isn’t an alternative to good manufacturing practices

Question 6

why is it important that certain preparations are sterile

Answer 6

1. some preparations are placed inside the body
   - injections, implants, sutures, dialysis fluids
2. some come into contact with broken skin and mucosal surfaces
3. risk of product degradation
   - these all pose a threat of infection

Question 7

give examples of normal major bacterial flora in the human body

Answer 7

1. mouth- staph. epidermidis
2. skin- staph epidermis
3. upper respiratory tract- staph epidermis
4. intestine- escherichia coli
5. urogenital tract- staph epidermis

Question 8

give examples of microbe free areas in internal tissues and organs

Answer 8

middle and inner ear, sinuses, muscles, brain and spinal cord

Question 9

give examples of microbe free areas in body fluids

Answer 9

blood, cerebrospinal fluid, urine in kidneys and bladder

Question 10

what are the properties of ideal sterilisation methods

Answer 10

1. high antimicrobial activity (giving high SAL)
2. easily controllable/measurable/understood physical conditions for microbial inactivation
3. terminal sterilisation
4. material compatibility
5. no hazard to operator
6. no toxic residues
7. short processing times
8. low cost

Question 11

what are the 2 strategies for making sterile products

Answer 11

1. make the product under non sterile conditions using non sterile ingredients then sterilise it at the end of the process
   - terminal sterilisation
2. make the product from sterile ingredients under sterile conditions
   - aseptic manufacturing

Question 12

which strategy of making sterile products is preferred

Answer 12

wherever possible, sterilisation in the final container is preferred (terminal)

Question 13

what is parametric release

Answer 13

system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to PR

Question 14

When is parametric release used

Answer 14

PR may be permitted for products sterilised using certain processes (no sterility test)
- PR requires permission to be granted

Question 15

Give examples of items which require sterilisation

Answer 15

1. ampoules of water for injection
2. infusion packs
3. dry powders
4. oils
5. disposable plastic gloves
6. delicate equipment
7. thermolabile liquids
8. indwelling medical devices (catheters)
9. wound dressings
10. contaminated blankets
11. wastes
12. media

Question 16

What are the methods for sterilisation recommended by Pharmacopoeia

Answer 16

1. dry heat
2. steam sterilisation
3. ionising radiation
4. gas sterilisation
5. filtration