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
What are the two main techniques used in transfer disinfection?
- Gassing
- Spray & wipe with 70% alcohol
What is the minimum number of stages of decontamination in transfer disinfection?
3.
spray-wipe-spray
What are the main considerations with spray & wipe disinfection?
- Wear gloves & dedicated clothing
- Work in spraying booths with fume extract or drip trays
- Use aerosol spray with correct droplet size
- Wet all surface especially labels
- Wipe surfaces using swab
- Contact time & surface drying time
Aseptic processing is controlled through
- Validation of equipment, processes, techniques & staff
- Use of SOPs, monitoring, training & competency assessment
Why is validation and monitoring of the aseptic process important?
In order that Aseptic products can be consistently prepared to required quality
How do you do microbial validation of aseptic process?
Process validation
- Demonstrate competency of facilities and operator by process simulation
Operator validation
- Demonstrate staff competency in techniques
Cleaning validation
> =3 times initially & regularly thereafter
What does cleaning validation confirm?
- Removal/inactivation of microbial contaminants
- > surface sampling before and after cleaning using swabs/contact plates
- Removal of chemical contamination
- > Use chemotherapy agent surface monitoring kit which detects cytotoxic agents
- Removal of biological/viral contamination
How can you do microbial monitoring of the environment?
Air - Active sampling - Passive sampling Finger dabs Surface sampling Swabs Contact plates
Incubate for 5 days at 30-35C, assess contamination
How can you do microbial monitoring of the operator?
- Hand washing
- Gowning
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Overview of Personalised & Bespoke Medicines31
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Intro to Extemporaneous Dispensing3
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Legal and Ethical Issues20
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Pharmaceutical Quality Systems (PQS)/Quality Management Systems (QMS)23
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Contamination control28
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Safe Handling of Hazardous Materials25
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Central Intravenous Additive Service (CIVAS) Products19
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QC & QA compliance requirement for final release22
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Parenteral Nutrition29
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Radiopharmacy19
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Storage, Transport & Distribution18
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Biologicals10
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Gene Therapy14
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Clinical Trials in Small Scale Preparation13
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Practicals17
