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
