Julie: contamination control Flashcards
What are the 6 sources of contamination?
- People
- Workplace
- Starting materials and consumables
- Storage
- Aseptic processes
- Administration
How can people provide contamination?
- Respiratory droplets which contain bacteria.
- Shed dead skin particles containing bacteria and or particulates.
- This shedding increases with movement, operator competency is vital.
How can the workplace itself be a source of contamination?
The air itself can harbour contaminants:
- Dust
- Spores of bacteria etc.
- Yeast:
How can the starting materials or consumables used in production be a source of contamination? [3]
- Viable microorganisms in the packaging. Labels especially.
- Contamination can be introduced during storage,
- Improperly produced starting materials may themselves contain particles or be contaminated with microorganisms etc, Only using certified products can avoid this mostly.
What are the causes of contamination most often found during the aseptic process itself? [7]
- Operator induced, not trained properly.
- Staffing level related.
- Supervision lacking.
- Inadequate transfer disinfection.
- inadequate storage of opened ampoules.
- Number of sterile manipulations performed directly correlates with incidence of contamination.
- Work flow issues, non-appropriate or non-existent levels of workflow segregation.
Who is responsible for minimising risk? [2]
- All staff involved
2. Primarily the Pharmacist.
How can contamination provided by operators be minimised?
- Appropriate protective clothing used: PPE, Hazmat suit, clean room suits.
- Changes in personal behaviour: no outdoor clothing in changing areas, personnel hygiene, no infections or skin lesions, no jewellery/make-up, appropriate handwashing techniques.
- Optimum staffing levels, not too many, not too few.
- Optimum staff competency: training and assessments regular.
How are the contamination risks associated inherent with the workplace minimised? [3]
- Filter the air via HEPA filters
- Positive pressure/negative pressure when appropriate.
- BSC or Isolators/Laminar flow etc.
How should the cleaning and disinfection of clean rooms occur? [5]
- Cleaning then disinfection, essential to reduce contamination.
- Should be regularly done according to a SOP and a log kept.
- Log kept should document agents and procedures used each time.
- Cleaning staff should be trained and assessed before working alone.
- Effectiveness of cleaning and disinfection must be demonstrated through regular microbiological and chemical sampling.
How should the cleaning and disinfection of clean rooms occur? (Agents used etc.) [5]
- With surfactants, hypochlorites, phenolics.
- Disinfectant rotation should occur.
- Sterile disinfectants used.
- In-use dilutions for cleanrooms should be stored in other areas when not in use.
- Thorough wetting should occur, contact time and drying time will need to be considered.
How does the cleaning of isolators/laminar flow cabinets occur?
Sterile neutral detergent at start and end of each session PLUS a weekly alcohol bleach.
How is the risk from contaminated starting materials limited?
Sterile products produced by licensed vendors.
Consumables should be pre-sterilised by the manufacturer and packaged correctly.
The operator should, however, endeavor to maintain sterile conditions throughout operations.
How is the risk of contamination posed by storage limited? [4]
- Store at 2-8*C in refrigerator when appropriate.
- Store in dust free environments with minimal packaging + handle appropriately.
- Minimise the time between preparation and administration.
- Have a maximum expiry date of 7 days.
How must transfer disinfection occur? [3]
- Prior to transferring components into A+B standard areas.
- According to written and validated SOPs
- Initial bioburden controlled and regularly monitored.
How does transfer disinfection occur? [2]
2 main processes:
- Gassing
- Spray and wipe with 70% alcohol: wear gloves, use fume extraction, ensure good aerosol droplet dispersion and coverage of packaging esp. label. Consider contact and drying times.
