Clean Rooms 🧹🧹 Flashcards
What is the definition of a clean room?
A room within which the number of airborne particles is controlled and classified and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room
What is aseptic preparation?
Should take place in special facilities designed to minimise both microbial and particulate contamination. Process of preparation without contamination.
What are the factors that affect product preparation?
Complexity of product preparation Potential for contamination Potential for microbial growth Health and safety risks to operators Chemical stability Potential incompatibility Duration of infusion Clinical issues
What are the four grades of a clean environment and what are they all used for?
Grade A- cleanest environment, where high risk operations take place. Provided by isolators and laminar airflow cabinets
Grade B- is the background environment for grade A zone
Grade C and D are for less critical steps
Where do tasks such as putting ingredients and getting equipment ready take place??
Ancillary areas
What room features are needed for clean rooms??
Internal surfaces should be smooth and impervious and suitable for cleaning.
Windows should be non opening
Few shelves as possible
Light should be responsive to motion not switches
Sinks and drains not permitted
Environmental standards for clean rooms
Number of particles, air changes, air flow velocity and pressure differential between rooms of different grades
How is the air filtered through a clean room??
Via a HEPA filter which ensure no dirty air flows back into the room.
Air is also actively removed ‘exhausted air’ which is recirculated through the plant and mixed with ~ 20% fresh air to start process all over again
Around 80% of air is extracted and recirculated
How is a pressure differential achieved?
Keeping pressure higher in cleaner areas and using doors as airlocks
How are larger particles removed?
Through pre-filters and bag filters as they are less expensive
What are prefilters and what are they used for?
Designed to removed visible debris- this helps to protect the filter from getting damaged by larger particles and also from getting blocked
What are HEPA filters made up of?
Mad who if a continuous sheet of paper like filter medium of long glass fibres. The filter is pleated too increase surface area
How does a HEPA filter work?
As air passes through the filter, particles in the air are carried through the filter media, these particles collide with the fibres of the filter and with other particles already stuck to the fibres, when this happens the Pericles are captured and retained within the filter
What is the minimum standards of air change for a clean room per hour
20
What are LFCs and how do they work?
They are protective workstations supplied with uni directional flow of filtered air. Air drawn from the clean rooms enter LFC via HEPA filters. Air flow maybe horizontal or vertical depending on work being carried out
What is an alternative to an LFC and how does it work?
Isolator - device that separates an environment in which pharmaceutical processes/activities are undertaken from the operator and surrounding environment.
What is a type 1 positive pressure isolator and what are they used for?
Air pressures with in the isolator are higher than the pressure in the room. Designed principally to offer maximum protection for the products being produced
Used for total parenteral nutrition and antibiotics
What is a type 2 negative pressure isolator and what are they used for?
Operate at a lower pressure than the ambient pressure. Offers protection to the operator. Used for cytotoxic drugs and radio pharmaceuticals
What are transfer devices used for?
Allow material to be transferred in and out of isolator without exposing the isolator work space to the room environment
Clean room behaviour
Maintaining good personal hygiene No eating or drinking No jewellery, cosmetics, nail varnish Nails short and clean No mobiles Slow deliberate movements
Properties of fabrics for clean rooms
No Linting- Pore size 15-40 microns Withstand sterilisation Anti static Non woven fabrics
Factors to be considered when choosing a disinfectant
Should have a broad spectrum of activity
Safe in terms of operator, environment etc.
Contact time to exert effects
Availability of different formats
Whether it can be sterilised
Most commonly used disinfectant
Aqueous alcohol due to reduced sporadical ability rotated with chlorine based products
Where are the different places that need to be cleaned and how often??
Cabinets and isolators - beginning and end of every session
Benches-beginning and end of every session
Floors-daily
Walls and ceilings- weekly/monthly
Give examples of active sampling of a clean room
Swabs and contact plates
Continuously monitor air quality
Settle plates for air quality
How is the operators cleanliness checked?
Pads of fingers pressed onto the surface of nutrient agar 🧫 which is then incubated
What are the most common mediums that are used to detect bacterial and fungal respectively??
Tryptone soya agar- (bacteria)
Saboraud dextrose sugar (fungal)
Give examples of good aseptic technique
Check gloves for damage before work Use strict no touch technique Avoid contact with any surface which may contact sterile fluid path Use closed systems wherever possible Keep area clutter free Work in an orderly manner
