Frequently Asked Questions - Technology

FAQs - containers and equipment
FAQs - process
FAQs - air quality, sterility issues
FAQs - barcodes
FAQs - other

Containers and Equipment

What are primary considerations for your focus on final containers (IV bags, syringes, etc.) flexibility?
Extensive research has shown that the main reason for the lack of adoption of existing automated IV preparation machines was their use of proprietary and non-standard final containers. Point of Care Clinicians and hospital pharmacists have selected a particular vendor’s IV bags, syringes and other finale IV containers based on their experience and patient safety concerns. Other automated solutions have attempted to force hospitals to switch from their preferred final IV containers to a proprietary and more expensive final IV container solution pushed by the automation vendor as the only supported container (for instance non-standard Terumo syringes). We do not believe this approach is in the best clinical or financial interests of either Primus Innovations or its customers and have therefore designed maximum flexibility in CytoCare™, not only to support multiple current standard final IV containers but to also be able to adapt to future changes in the final IV containers market segment without the need to re-design the robot.

How does the machine deal with excess pressure/void inside the vials/bottles?
CytoCare™ uses vented needles that allow pressure compensation while extracting the fluid. This minimizes the generation of aerosols or dripping

Is it possible to use 1000 ml IV bags?
Yes, we support IV bags up to 1000 ml.

Can you calibrate the machine to adjust for syringes’ tolerance levels?
Every time a syringe lot is changed, CytoCare™ uses its weighing system to get the calibration factor of that given syringe lot. This is necessary because, according to the ISO standard, syringes are allowed a variation up to 4% between lots. Because CytoCare™ wants to provide a higher precision, this calibration step is put in place.

What is the type or brand of syringe hospitals typically use with CytoCare™?
Becton-Dickinson Plastipak or similar.

Is the syringe a single-use syringe-needle combination, or is it used repeatedly if the drugs and containers are part of a batch series of preparations?
Both are correct. Basically it is one preparation/one syringe. But if the pharmacist has multiple preparations using the same drug, a single syringe can be used for more than one preparation (in order to speed up throughput). There is also the customary case of a preparation using one drug and some additions to the IV Admixture (e.g., vitamins, anti-emetics, etc.); in which case each dose component is managed with a different syringe-needle combination.

How are syringes as final containers filled?
Whenever a syringe is used as final container, it is pre-labeled with a barcode, as any other final container utilized by CytoCare™. The robot will then look for that syringe in that size in the appropriate location within the CytoCare™ carousel. Should the syringe not be available in the carousel, the software will ask the operator to load it into the system.

How do you extract excess liquid (glucose, saline) from containers?
This is done by a separated dedicated system, using a continuous aspiration pump, which can extract any quantity in one go. In order to grant precision and safety, weight of containers is checked before and after extracting the liquid.

Process

Can the machine detect precipitation problems with the video system?
In theory yes, but all vials are covered by labels, so it is almost impossible to rely on this system for a quality check. If required, the operator can check the vials before loading them, in order to assess medication quality and absence of precipitation.

Does the machine produce air bubbles?
So far we never detected this problem. The machine can be set to draw liquids very slowly and uses non-coring vented needles.

Does the machine allow drawing liquids with high viscosity?
The 16G needles, which are currently used, fit all kind of liquids while granting precision through a laser controlled, syringe activation mechanism (patent pending). Thus there is no need to change needles.

Does the machine insert a pin into the cavity left by the needle?
No, but the machine uses special non-coring needles to avoid this problem and, in general, the vials' rubber caps are designed to avoid generation of a cavity after the needle is taken out.

How does the CytoCare™ labeling process work?
Every final container (bag, bottle, syringe, elastomeric pump …) needs to be labeled prior to entering the system. This label can be put even days before and simply contains a barcode and a unique sequential number. When the container enters the system and is picked for a given preparation, the machine reads that barcode and associates it to that very preparation. When the finished preparation gets out of the system, you simply need to read that barcode and the final label will be issued, containing whatever information the hospital deems appropriate. You can read the original label whenever you want, in case you want to double check the final label. In theory, both the original barcode information and the final label barcode could be sent to a point of care scanning device for final double check prior to administration.

Is it possible to extract liquid from a final container prior to injecting the medication?
The system allows you to partially or totally retrieve the required quantities. You can extract from the final container excess fluid if you want the final solution to have a precise weight. You can also use part of a medication vial and leave the rest for a second preparation

In the infuser video, it looks like the needle is entering the infuser through luer lock cap, is it correct?
Yes, the machine uses a luer-lock access point to inject liquids into the infuser. The lock cap is not removed during the preparation.

Can CytoCare™ identify possible deficits or surpluses of drug volumes inside the drug vials, and if so how?
Drugs vials are weighted on a precision balance prior their use.

When entering the drug to solution bottle, does the needle empty fully or is some drug left there? How one can guarantee this?
The max amount of liquid that can remain within a needle is 0.02ml.

Can a user define the speed, duration and number of revolutions on the reconstitution wheel in each plane for different admixtures in order to ease the potential concern that certain proteins cannot be rotated in two planes because they are likely to coagulate inappropriately?
Yes. Speed and duration are drug-specific and can be stored in the internal database in order to adapt the reconstitution to the specific drug properties.

Based on user preference, can CytoCare™ suspend reconstitution until the operator visually confirms the mixture is complete before proceeding to the next step?
Yes, this is a standard feature that can be activated according to the user's preferences.

Does CytoCare™ allow drawing liquids with high viscosity?
The 16G needles, which are currently used, fit all kind of liquids while granting precision through a laser controlled syringe activation mechanism. There is no need to change needles.

Are the drug vials completely emptied?
CytoCare™ can draw the entire content of the vial

Can you calibrate the machine to adjust for syringes’ tolerance levels?
Every time a syringe lot is changed, CytoCare™ uses its weighing system to get the calibration factor of that given syringe lot. This is necessary because, according to the ISO standard, syringes are allowed a variation up to 4% between lots. Because CytoCare™ wants to provide a higher precision, this calibration step is put in place.

Does the CytoCare™ software comply with quality standards?
The CytoCare™ software complies with the validation path identified in the ISO norm 12207:1995 “Software Life Cycle Processes”, which is also the reference document for the FDA guidelines for Pharmacy Compounding Systems.

Sterility and Air Quality

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.

Does the equipment include all that is needed for air filtering?
Nothing additional is needed except an adequate room and 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.

How can we grant good cleaning and sterility of the robotic arm?
The robot has been especially designed for clean rooms. Cleaning instructions foresee wiping the arm with quaternary ammonium followed by 70% isopropyl alcohol spraying. Overnight UV-C lamps prevent bacterial growth when the unit is not running.

Barcode

Does the barcode reader for the vials capture and record the data in the various sub-fields or only the image of the barcode?
Most cytotoxic drug vials do not have a bar code on the vial label, but only on the carton case containing the vial. For this reason we adopted a computer vision system, able to recognize the specific drug vial from the image of its label. This system can also read the barcode (if present) and also read characters printed on a specific position of the label (e.g.: "0.5 mg / 10 ml").

Is the barcode data searchable?
Barcodes generated to label final solutions are unique and are stored in the database of CytoCare™.  A query to the database can be done reading the barcode on an ID station or simply entering manually its number. If that barcode has been associated to a preparation, all data relevant to this preparation are retrieved from the database. This can allow, for example, for a final check of the IV bag just before administering it to the patient (e.g.:  in the hospital nurse station or patient bed from a PC or a wireless pocket PC connected to the hospital LAN).

How do we know that the right barcode label is affixed to the right final container?
Every final container (bag, syringe, elastomeric pump, etc.) is pre-labeled prior to entering the system. This label can be put even days before and simply contains a barcode with a unique sequential number (not associated either to a patient or to a preparation). When a container enters the system and is picked for a given preparation, the machine reads its barcode and associates it to that specific preparation. When the finished preparation gets out of the system, its barcode is read and a second label is issued, containing preparation data (i.e.: patient name, drug, qty., time, etc.). The consistency of the two labels can be checked whenever any hospital employee desires, both by a barcode reader and by a visual inspection (i.e.: just reading the two numbers). If the hospital HIS supports it, both the original barcode information and the final label barcode could be sent to a point of care scanning device for final double check prior to administration.

Other

Is it possible to identify the operator through biometric ID (finger print)?
Yes, this is available as an option within CytoCare™, both in North America and International installations.

How does the machine handle drugs with special storage requirements (e.g. refrigerate, protect from light)?
The machine is not refrigerated (but the same happens in a LAF cabinet...). Refrigeration and light constraints are converted in a maximum time of stay of the vial in non-refrigerated / non-dark conditions. This maximum time of stay can be defined by the user for each drug, according to pharmacy procedures, drug manufacturer directions, regulatory requirements, etc.

Regarding the tracking of manufacturer/lot number/expiration of the drugs, how are the data stored, and accessed when needed?
These data can be entered in the system when the drugs are loaded in the machine. They are permanently stored in the database and are included.

FAQs - installation
FAQs - general