Contamination control Flashcards
What are the main sources of microbial contamination in an aseptic suite?
- People
- Workspace
- Starting materials & consumables
- Storage
- Aseptic process
- Administration
What are the main ways of products becoming contaminated from People?
- Respiratory droplets
- Shedding of dead skin
- > Shedding increases with movement
- Competency is vital
What are the main ways of products becoming contaminated from Workspace?
- Air quality
- Cleanliness of surfaces
What are the main ways of products becoming contaminated from Starting materials & consumables and Storage?
- Viable microorganisms in the starting materials or consumables used
- Contamination can be introduced during storage
How do you minimise risk of contamination by Aseptic process?
- Operator
- Staffing
- Supervision
- Transfer disinfection
- Storage of opened ampoules
- No. of sterile manipulations performed
- Work flow
How do you minimise risk?
QA, QC, GMP and Risk Management
How do you minimise risk of contamination by people?
- Clothing
- Behaviour
- > Good personal hygiene
- > No infections/skin lesions
- > No jewellery or makeup
- > Minimise movement of staff
- > Optimise no. of staff
- > Good work flow - Comfort
- Competency
- > All staff must be trained and assessedo
How should you assess staff competency?
- Observation & supported questioning
- Regular reassessments required
How do you minimise risk of contamination by work space?
- Filter air through HEPA filter
- Maintain at +ve pressure
- Perform aseptic operations in a biological safety cabinet (BSC) or laminar flow cabinet sited in either Grade A or B area
- Work areas must be clean, dry and tidy
In what order do cleaning and disinfection occur?
Cleaning is always BEFORE disinfection
Cleaning & disinfection of aseptic facility…
- Must be regularly cleaned and disinfected according to SOPs
- Log kept of areas cleaned and agents used
- Use dedicated cleaning equipment & clothing
- Training and assessment
- Effectiveness must be demonstrated through regular microbiological (and chemical) sampling
How should you normally clean and disinfect grade A-D rooms?
- Employ disinfectant rotation
- Sterile disinfectants for Grade A & B areas (spores free in other areas)
- In-use dilutions for Grade A & B areas (stored for defined periods in other areas)
Optimum techniques
- Ensure thorough & complete wetting
- Consider contact time & surface drying time
- Wiping essential
How do you minimise risk of contamination by starting materials & consumables?
Starting materials:
- sterile products with a product license
Consumables:
- pre-sterilised by the manufacturer & packages correctly
Sterility must be maintained by the operator
How do you minimise risk of contamination during storage?
Starting materials: - refrigerate (2-8C) where appropriate Other consumables: - store in dust free environment - minimise packaging - handle appropriately Products: - Minimise time between prep. & administration - Maximum expiry date of 7 days (longer if prepared in a licensed facility) - Refrigerate (2-8C) where possible - Handle appropriately
What is transfer disinfection?
Surface disinfection prior to transferring components into grade A and B environments
- Vital in preventing contamination
- Performed according to written, validated SOPs
- Initial bioburden must be controlled & regularly monitored
