Does CytoCare periodically test/document the air quality in the chambers?
Air quality is certified by tests done at the end of the manufacturing process. Air sampling ports are provided in order to allow
hospitals to perform routine quality assurance tests using a particles counter (not included with CytoCare).
How long does it take to refresh all of the air in each chamber?
Mean air velocity in the chambers is approximately 0.5 m/s. This means that the air in the two chambers is totally refreshed
every two seconds.
Is all air vented externally (not back into the room)?
For maximum safety, all exhaust air is HEPA filtered and vented externally, through the ductwork. Inside Cytocare there is a 70%
recirculation (in order to decrease the demand of fresh air from the room conditioning system), but in any case no air is vented
back to the room.
If a contamination were to occur, how it is detected and do you have best practice recommendations for
sterilizing the machine?
Major contaminations (e.g.: drug spillage) are detected by the weighting system, that identifies unjustified weight losses of the
drug vials occurred during the compounding process. Minor contaminations (e.g.: aerosols) cannot be automatically detected,
but their amount is equivalent to the one occurring in normal manual compounding. Recommended de-contamination procedures
are the same normally used for laminar flow cabinets and can vary according to specific hospital rules. In Europe, for example,
a normal decontamination procedure is base on a double cleaning with quaternary ammonium solution followed by a final
cleaning with isopropilic alcohol.
How does CytoCare deal with excess pressure/void inside the vials/bottles?
CytoCare uses vented needles, that allow pressure compensation while extracting the fluid. This guarantees the absence of
aerosols or dripping.
Does the equipment include all that is needed for air filtering?
Nothing additional is needed except an adequate room + exhaust ductwork
How can you grant sterility of the items inside the machine?
Sterility is granted by the fact that the ambience inside the machine is continuously fed by a >0.5 m/s flow of sterile, HEPA
filtered air. As a good practice, all components introduced in the machine should be wiped with 70% isopropilic alcohol. This
cleaning procedure can be performed using the special laminar flow window provided in the new machine. The same applies to
needles and syringes, which can be opened inside the dedicated laminar flow window (i.e.: within a sterile environment)
Is the atmosphere inside CytoCare in positive or negative pressure versus the outside?
The atmosphere inside CytoCare is in depression (negative pressure) versus the outside in order to avoid any possible
contamination of the room.
How does CytoCare avoid cross-contamination?
Cross contamination is avoided as no part of the robot comes into contact with medications. Cytocare uses disposable syringes
and the special non-coring vented needles avoid creation of aerosols/spraying.
When the same vial is used for multiple patients, is there a risk for surface contamination?
This risk exists even in the manual preparation process. Cytocare keeps the open vial within the sterile environment, well away
from contamination sources, and re-uses the remaining medication when required. In case the vial needs to be stored in a
temperature controlled environment it is possible to take it out, label it and store it elsewhere. In this case of course,
contamination danger might be higher.
Air quality is certified by tests done at the end of the manufacturing process. Air sampling ports are provided in order to allow
hospitals to perform routine quality assurance tests using a particles counter (not included with CytoCare).
How long does it take to refresh all of the air in each chamber?
Mean air velocity in the chambers is approximately 0.5 m/s. This means that the air in the two chambers is totally refreshed
every two seconds.
Is all air vented externally (not back into the room)?
For maximum safety, all exhaust air is HEPA filtered and vented externally, through the ductwork. Inside Cytocare there is a 70%
recirculation (in order to decrease the demand of fresh air from the room conditioning system), but in any case no air is vented
back to the room.
If a contamination were to occur, how it is detected and do you have best practice recommendations for
sterilizing the machine?
Major contaminations (e.g.: drug spillage) are detected by the weighting system, that identifies unjustified weight losses of the
drug vials occurred during the compounding process. Minor contaminations (e.g.: aerosols) cannot be automatically detected,
but their amount is equivalent to the one occurring in normal manual compounding. Recommended de-contamination procedures
are the same normally used for laminar flow cabinets and can vary according to specific hospital rules. In Europe, for example,
a normal decontamination procedure is base on a double cleaning with quaternary ammonium solution followed by a final
cleaning with isopropilic alcohol.
How does CytoCare deal with excess pressure/void inside the vials/bottles?
CytoCare uses vented needles, that allow pressure compensation while extracting the fluid. This guarantees the absence of
aerosols or dripping.
Does the equipment include all that is needed for air filtering?
Nothing additional is needed except an adequate room + exhaust ductwork
How can you grant sterility of the items inside the machine?
Sterility is granted by the fact that the ambience inside the machine is continuously fed by a >0.5 m/s flow of sterile, HEPA
filtered air. As a good practice, all components introduced in the machine should be wiped with 70% isopropilic alcohol. This
cleaning procedure can be performed using the special laminar flow window provided in the new machine. The same applies to
needles and syringes, which can be opened inside the dedicated laminar flow window (i.e.: within a sterile environment)
Is the atmosphere inside CytoCare in positive or negative pressure versus the outside?
The atmosphere inside CytoCare is in depression (negative pressure) versus the outside in order to avoid any possible
contamination of the room.
How does CytoCare avoid cross-contamination?
Cross contamination is avoided as no part of the robot comes into contact with medications. Cytocare uses disposable syringes
and the special non-coring vented needles avoid creation of aerosols/spraying.
When the same vial is used for multiple patients, is there a risk for surface contamination?
This risk exists even in the manual preparation process. Cytocare keeps the open vial within the sterile environment, well away
from contamination sources, and re-uses the remaining medication when required. In case the vial needs to be stored in a
temperature controlled environment it is possible to take it out, label it and store it elsewhere. In this case of course,
contamination danger might be higher.
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