Contamination control Flashcards
what is the most common source of contamination?
People
What are the six main causes of contamination
People workspace starting materials/consumables Storage Aseptic process Administration
How do people causes contamination?
Produce respiratory droplets which contain bacteria
Sheading of skin particles
What non-spore forming bacteria commonly contaminates air?
Staph.coccus, Strep.coccus and micrococcus
What bacterial spores commonly contaminate air?
Baciullus spp and clostridium spp
What species of yeast commonly contaminates air?
Rhodotrula
what fungal spores commonly contaminates air?
Penicillium, cladosporium, aspergillus, mucor and candida
Who responsibility is it to minimise risk?
Responsibility of all the staff, but especially the pharmacy manager
How can we minimise risk of contamination by people?
- Clothing
- Behaviour - hygiene, no skin infections, hand washing, optimising the no. of staff, good work flow
- comfort - well lit, temp and humidity optimised
- competency
- completion of training documented
regular reassessments required
How can we minimise the contamination caused by the workspace?
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)
What comes first cleaning or disinfection?
Cleaning always precedes disinfection as it is essential to remove/reduce contamination.
What does the Quality assurance of aseptic preparation services chapter 12 state?
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.
What disinfectants are commonly used in grade A-D clean rooms?
Surfactants, hypochlorites, phenolics
Outline cleaning/disinfection of grade A-D rooms
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.
What is meant by in-use dilution?
Disinfectant is diluted immediately before use to ensure disinfectant is still active.
How can we minimise the risk through starting materials and consumables?
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.
How should starting materials be stored?
Refrigerate (2-8) where possible.
Store in a dust free environment, minimise packaging, and handle appropriate.
An exempt product produced in an unlicensed facility has a max expiry date of what?
7 days
What is transfer disinfection?
Surface disinfection prior to transferring components into grade A and B environments is vital in preventing contamination.
Performed according to written, validated SOP.
What are the two main disinfection processes
- Gassing
2. Spray and wipe with 70% alcohol
What are the min 3 stages of decontamination?
Spray-wipe-spray
Outline the process of of transffer disinfection
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
Outline the components of validation of aseptic processes
- Process validation - demonstrate competency of facilities and operator by process simulation
- 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 - Cleaning validation
Should be carries out at least three times initially and regularly thereafter
How can we monitor the environment for microbial contamination?
Air - active sampling/passive sampling (settle plates)
Finger dabs
Swabs and contact plates - surface sampling
Incubate for 5 days at 30-35’C a
