Contamination control

Question 1

what is the most common source of contamination?

Answer 1

People

Question 2

What are the six main causes of contamination

Answer 2

People
workspace
starting materials/consumables
Storage
Aseptic process
Administration

Question 3

How do people causes contamination?

Answer 3

Produce respiratory droplets which contain bacteria

Sheading of skin particles

Question 4

What non-spore forming bacteria commonly contaminates air?

Answer 4

Staph.coccus, Strep.coccus and micrococcus

Question 5

What bacterial spores commonly contaminate air?

Answer 5

Baciullus spp and clostridium spp

Question 6

What species of yeast commonly contaminates air?

Answer 6

Rhodotrula

Question 7

what fungal spores commonly contaminates air?

Answer 7

Penicillium, cladosporium, aspergillus, mucor and candida

Question 8

Who responsibility is it to minimise risk?

Answer 8

Responsibility of all the staff, but especially the pharmacy manager

Question 9

How can we minimise risk of contamination by people?

Answer 9

1. Clothing
2. Behaviour - hygiene, no skin infections, hand washing, optimising the no. of staff, good work flow
3. comfort - well lit, temp and humidity optimised
4. competency
   - completion of training documented
   regular reassessments required

Question 10

How can we minimise the contamination caused by the workspace?

Answer 10

HEPA filter
Maintain at positive pressure
Perform aspectic operations in a biological safety cabinet (BSC) or a laminar flow cabinet (if next to grade A/B area)

Question 11

What comes first cleaning or disinfection?

Answer 11

Cleaning always precedes disinfection as it is essential to remove/reduce contamination.

Question 12

What does the Quality assurance of aseptic preparation services chapter 12 state?

Answer 12

Clean areas must be regularly cleaned according to a written procedure. A log should be kept of the areas cleaned indicating the agents used.

Effectiveness must be demonstrated through regularly microbial and chemical sampling.

Question 13

What disinfectants are commonly used in grade A-D clean rooms?

Answer 13

Surfactants, hypochlorites, phenolics

Question 14

Outline cleaning/disinfection of grade A-D rooms

Answer 14

Employ disinfectant rotation - weekly/monthly/quaterly

Sterile disinfectants for grade a and b areas

In use dilutions for grade A and B areas (diluted immediately before use to ensure disinfectant is still active)

ensure thorough and complete wetting - consider contact time and surface drying time. Phenolics have a much longer drying time so need to apply for longer to be effective.

Question 15

What is meant by in-use dilution?

Answer 15

Disinfectant is diluted immediately before use to ensure disinfectant is still active.

Question 16

How can we minimise the risk through starting materials and consumables?

Answer 16

Starting materials should be sterile products with a product license.

Consumables should be pre-sterilised by the manufacturer and packaged correctly. sterility must then be maintained by the operator

All consumables must be CE marked.

Question 17

How should starting materials be stored?

Answer 17

Refrigerate (2-8) where possible.

Store in a dust free environment, minimise packaging, and handle appropriate.

Question 18

An exempt product produced in an unlicensed facility has a max expiry date of what?

Answer 18

7 days

Question 19

What is transfer disinfection?

Answer 19

Surface disinfection prior to transferring components into grade A and B environments is vital in preventing contamination.

Performed according to written, validated SOP.

Question 20

What are the two main disinfection processes

Answer 20

1. Gassing

2. Spray and wipe with 70% alcohol

Question 21

What are the min 3 stages of decontamination?

Answer 21

Spray-wipe-spray

Question 22

Outline the process of of transffer disinfection

Answer 22

wear gloves and dedicated clothing
Work in spraying booths with fume extract or drip trays
Use aerosol spray with correct droplet size
wet all surfaces especially labels
wipe surfaces using swab
contact time and surface drying time is important

Question 23

Outline the components of validation of aseptic processes

Answer 23

1. Process validation - demonstrate competency of facilities and operator by process simulation
2. Operator validation - demonstrate staff competency in techniques via:
   - withdrawal of a solution from an infusion bag, vial and ampoule
   - addition of a solution to an infusion bag, and vial
   - addition of a solution to a vial
3. Cleaning validation

Should be carries out at least three times initially and regularly thereafter

Question 24

How can we monitor the environment for microbial contamination?

Answer 24

Air - active sampling/passive sampling (settle plates)
Finger dabs
Swabs and contact plates - surface sampling

Incubate for 5 days at 30-35’C a