General #
Q: What is the size and weight of the Mundus Mini?
A:
Q: What is the speed (preps/hr)?
A: As part of the validation, we are testing the Mundus Mini production rate. The device is intended to compound more than 20 preparations per hour.
Q: How many preparations can it do at a time?
A: Only one preparation at a time.
Q: Can it do batch preparations?
A: No. It can prepare individualized preparations, one at a time.
Q: What makes it better than competitors?
A:
- Uses CSTD throughout the whole compounding process
- Uses AI + image processing for multiple features such as vial ID, IV bag ID, dose validation etc.
- Compact size
- Relatively easy installation
- Photo documentation
- Extremely user-friendly with prompts; makes the training process very simple
- No calibration is needed, and no real maintenance is needed
Q: Will using it change my current workflow?
A: No (or minimally). We designed the machine to fit into your existing workflow. You will continue with your same workflow as prior, with the added benefits of what the Mundus Mini has to offer (dose accuracy, vial and IV bag verification, reduced stress injuries, documentation, etc).
Q: Will my staff have to be trained to use it?
A: Yes. (The training should have documentation that is maintained by the facility.) However, training requires minimal time and resources. Since the machine is so intuitive and user-friendly, the training process will be relatively simplified.
The user interface was designed to be used by people of all ages and comfort levels with technology. Most new users feel comfortable with the machine in a matter of minutes/hours (compared to days/weeks).
Equashield will have a lot of training resources available such as the user manual, ‘how to’ videos, placards, and more.
Q: Can I buy a Mundus Mini to use for antibiotics (non-hazardous)?
A: The Mundus Mini’s intended use is to work with hazardous drugs.
Clinical Operations #
Q: What kind of preparations will it make?
A: IV bags and syringe preparations only. We will perform testing to see if we can incorporate elastomeric pumps and semi-rigid bottles in the future.
Q: What kind of consumables (vials and IV bags) does it work with?
A: We should be compatible with the most common consumables on the market since we interface with the CSTD mostly. However, some general ‘rules’:
Vials:
- Vials that are compatible with VA-13, VA-13C, VA-20, and VA-20C
- Vials that can be manually compounded with the EQ system
- Vials that labels aren’t covered by the Vial adaptor
IV Bags:
- IV bags that can be used with SA-EZ or SA-EZ/D
- ‘Soft’ IV bags
- IV bags with text/barcode
Tubing Sets:
- Only EQUASHIELD tubing sets at this time
Q: Does it work with semi-rigid bottles(ecoflac)?
A: Currently, it is not compatible. In the process of exploring potential solutions.
Q: Does it work with drugs with high viscosity? MABs?
A: Yes. We are in the process of validation. Mundus Mini should be able to work with most drugs that can be manually compounded using the EQ system. There may be some exceptions, but we will know more once we are operational in beta sites.
Q: Are there any Hazardous drugs that it cannot compound?
A: In general, it should be able to compound any drug that can be compounded manually with EQ. However, we will have more information once we have tested real drugs in beta sites.
Some guidelines for which drug to use in Mundus Mini:
- Drugs that can be manually compounded with Equashield
- Drug vial has a clear, intact label that isn’t covered by the vial adaptor
- Drug vial is compatible with VA-13, VA-13C, VA-20, or VA-20C (not VA-17, VA-28, VA-32, not ampules)
- Drugs that tend to crystallize/aggregate may not be ideal
- Drugs that tend to foam during reconstitution may not be ideal
Q: Can it do reconstitution?
A: Yes. Note, that reconstitution is a separate function from compounding. It will not reconstitute and then compound using the same vial. It requires the operator to perform a visual inspection of the reconstituted vial before using it in compounding.
Q: What happens if a drug runs out during the compounding process?
A: If there is not enough drug, the machine will recognize a huge air bubble that it can’t resolve (while attempting to withdraw the drug from the vial). The air bubble that can’t be resolved is the trigger to tell the machine that the vial is empty. The machine will prompt the user to load another vial of the same drug. Once another vial is loaded and validated as the correct drug, the compounding will continue and finish compounding the prescription.
Q: Can it compound a dose with multiple vials?
A: Yes. During initial loading, you can load 2 vials from the same medication. The machine will prompt you to load subsequent vials during the compounding process if more vials are needed (until the prescription is complete).
Q: Why are there 3 IV bag stations?
A: The 3 stations allow for flexibility in different circumstances. Some options:
- Final IV bag (for preparation)
- Diluent IV Bag
- Can interchange a spike station for a luer station
- In the future: can have a ‘waste bag’ for equal volume preparations
Q: What is the smallest dose that can be compounded?
A: We are finalizing the testing/validation to confirm. Currently, 0.3ml is the smallest dose.
Q: What is in the documentation (prescription report)?
A: All the data relevant to the compounding. It will also include high-resolution photos of drug vial / IV bag labels and filled syringe units that were taken as part of the compounding process.
Q: Can the machine replace a pharmacist/ technician?Â
A: From a practical standpoint, you still need a person to load and unload the machine, affix the closed system, and operate the user screen.
Regarding validation, it may potentially be possible to reduce staff involvement depending on the facility’s protocols and local regulations. Since the machine is doing the dose validation (and documentation), it may be considered sufficient from the facility/regulatory perspective and not require an additional ‘double-check’ from a 2nd pharmacist. Please consult your facility’s protocols and local regulations. Note: all final compounded products must be checked by the operator under all circumstances.
Installation Requirements #
Q: What is the installation process like?
A: Relatively simple compared to standard automation.
- Mundus Mini will be calibrated and validated in EQ facility (IQ, OQ processes)
- An EQ technician will arrive with the machine to assist with the installation
- Minimal testing performed in the facility before use (PQ process, more simplified)
- Software integration + testing: few days/weeks compared to months
- A reconstitution drug database needs to be created by local Pharmacy Supervisors
- No need to knock down walls, or interfere with the cleanroom
- No special equipment is needed (i.e. chiller, UPS, special electrical conditions)
Q: What are the minimum requirements of the biological safety cabinet (BSC) for the Mundus Mini?
A:
- Physical dimensions of the Mundus Mini should fit within the biological safety cabinet workspace (typically fits within a standard cabinet that is 1.3m (4ft) long)
- PEC should be ISO class 5 (Grade A)
- Should be able to withstand the weight capacity
Q: Can it operate within an isolator?
A: Compatibility with an isolator has not been tested at this time.
Q: Do you have any partnerships with hood companies?
A: We are in the process of developing relationships. We are partnering with NuAire in the U.S. and hope to have a partner in Europe as well.
Q: What are the clean room requirements?
A: ISO class 7 (Grade B/C)
Q: Where is the printer?
A: There is no printer in the Mundus Mini. The prescription labels will be supplied by the facility. The only requirement from the Mundus Mini is that it has the prescription info embedded within a QR code. Many EMR systems have this already. If this is not available at your facility, we will assist with getting this.
CSTD & Mundus Mini #
Q: Do we have to use the EQUASHIELD CSTDs?
A: Yes. The machine’s design and operation were built around the EQ CSTD capabilities and features.
Using the EQUASHIELD CSTD can offer many additional advantages such as:
- Safety, especially with our unique closed-back syringe
- Microbial ingress prevention
- Faster compounding: needle and syringe is slow, while we have a robust connection/disconnection
- Versatility: can use more types of vials and IV bags since the machine is generally interfacing with the CSTD and not with the consumable
All efficient automation will need to utilize a uniform consumable because otherwise constant calibration and adjustments are required. With the Mundus Mini, we utilize the EQUASHIELD CSTD a a uniform consumable that simultaneously offers protection against hazardous drugs.
Q: What EQUASHIELD CSTDs will it work with?
A: Currently, SA-EZ, SA-EZ/D, SA-EZ/E, SA-EZ/ST, SA-EZ/F, LL-2, and LL-2S. We are looking to expand to other CSTD components such as SA-EZ/W and SA-180. TBD.
Software #
Q: What are the software requirements?
- Intel 4-cores
- 8 Gb RAM
- Hard disk – 500Gb
- Windows Server 2019
- Internet connection
Q: What is the software integration like?
A: We don’t connect to the hospital EMR, we connect to a third party called InterSystems. InterSystems works with 80% of the EMRs in Europe. If your EMR doesn’t work with InterSystems, you need to subscribe to a membership (expense of the facility).
Step by step:
Hospital EMR will send the prescription to InterSystems.
We will receive the data needed for compounding from InterSystems.
Perform the compounding.
Send data back to InterSystems (prescription report etc.)
Hospital EMR will receive whatever data they are capable of receiving from InterSystems.
Q: Is the software communication bidirectional?
A: We provide the relevant data to InterSystems. It depends on the hospital’s EMR on what data they can receive in return.
Q: Can a supervisor or someone outside the clean room verify the compounding as it is happening (see the process)?
A: The supervisor or anyone who is not the operator can see the compounding report after the compounding is completed. The decision was made not to require external verification as it delays the throughput.
Q: Can I see the test report before it’s sent back to the EMR?
A: Currently, no. The prescription report will be sent automatically as soon as the compounding is complete.
Q: What is the safety/encryption used to protect sensitive data?
A: The software complies with all regulatory requirements regarding the protection of sensitive data (such as HIPPA and GDPR)
Also, no data is stored on the Mundus Mini. All data will be sent to the hospital server to be managed by the facility.
Q: Can you provide analytical data such as preparation logs and stock management?
A: Currently, no. We only provide the info directly related to the compounding process. Perhaps in the future.
Q: Does your software comply with 21 CFR part 11?
A: Yes.
Regulation #
Q: What standards does the Mundus Mini meet?
A:
- EU Machinery Directive 2006/42/EC.
- EU Low Voltage Directive (LVD) 2014/35/EU.
- EU Electromagnetic Compatibility (EMC) Directive 2014/30/EU.
- ISO 13485 Medical Devices – Quality management systems – Requirements for regulatory purposes.
- EN ISO 14971 Medical devices – Application of risk management to medical devices.
- EN 62304 Medical device software – Software life-cycle processes.
- EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
- EN IEC 61326-1 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements.
Q: What documents/approvals regarding authorization for use in the EU?
A: The Mundus Mini is considered a machine in the EU. Therefore, it is not regulated under the medical device regulations (MDR 2017/745).
It shall comply with the directives and standards mentioned above which are also applicable for medical devices (ISO 13485, ISO 14971, ISO60601, etc.) but will be marketed as a machine.
Q: Does the Mundus Mini meet GMP guidelines?
A: Mundus Mini meets ISO:13485 guidelines.Â
Q: Have you tested the airflow in the hood with the Mundus Mini?
A: We are currently in the process of testing.
Q: What is the accuracy? How do we achieve accuracy?
A: The Mundus mini’s accuracy verification process relies mainly on image processing, which is done by capturing key stages in the drug preparation process and identifying them with image recognition algorithms, as part of the device’s software.
All the processes executed in the device are controlled by cameras that are installed in the device combined with unique, custom-made, image processing algorithms. The image processing functions allow rapid feedback control over delicate and critical processes during the drug preparation process.
In addition, the accuracy of the device is being validated. The volumetric accuracy is compared to gravimetric accuracy by weighing filled / empty syringe units. The validation is performed with different types and shades of liquids (clear, dark, aqueous, and viscous).
Q: Does it have gravimetric verification?Â
A: No. Mundus Mini operates on different technologies that use cameras and image processing algorithms.
Gravimetric validation is a slow process and can be easily influenced by external factors such as airflow, electrical pulses, etc. It also requires frequent calibration from the user which can be time-consuming.
Our process uses image process algorithms that confirm dose accuracy from a pixelation standpoint. In other words, it is not reading the syringe gradients to ensure the correct dose was withdrawn. Rather, it is ensuring the amount of drug (determined by pixelation) that was captured in the image processing matches that the expected drug amount is withdrawn.
Note that the methods used for dose accuracy in the Mundus Mini will be validated and compared to gravimetric accuracy.
Q: Can I compound outside of the cleanroom using the Mundus Mini (or suboptimal conditions)?
A: The Mundus Mini is designed to work inside a PEC and in a cleanroom environment to maintain the sterility of the compounding process. Installing the Mundus Mini outside of the cleanroom will compromise the sterility of the preparation.
Q: I see a lot of moving parts. Is it safe for the user?
A: Yes. Safety is the highest consideration. We comply with all the regulations regarding machinery, safety, electricity, etc.
Also, the Mundus Mini is a ‘cobot’ – a collaborative robot. Cobots are designed to work with people in a shared environment and have advanced sensors and safety features without posing a risk of injury.
There is also an ‘emergency stop’ button that stops all movement if needed.
Cleaning #
Q: What is the cleaning process like? What materials? How often?
A: It is a manual cleaning process. We have a cleaning protocol that is in the process of being validated. Some info:
- Minimum 1x day after shift, sporicidal 1x week or month
- Before compounding, after a 24-hour pause, when dirty, when there is a spill
- Cleaning materials compatible with materials of construction
- No spraying on the machine, spray onto lint-free sterile wipes
Cleaning materials: all cleaning agents are commonly available
- Cleaning agent – Sterile Hydrogen Peroxide 0.5% or higher
- Disinfecting agent – Sterile Isopropyl Alcohol (IPA) 70%
- Cleaning / Deactivation / Decontamination / Sporicidal agent – Sterile mixture of Hydrogen Peroxide 4.0% and higher and Peracetic Acid 0.20% and higher
Q: How do I do a deep clean of the hood with the machine?
A: Most likely, you will be required to take out the machine. In the process of developing potential different solutions to make it easier to take out the hood. TBD
Commercial #
Q: When will it be available for purchase?
A: Our timeline is Q3/Q4 2024. Connect with your local distributor for more information.
Q: Where is it working? Is it in a beta site?
A: We are just starting the ‘soft launch’ in Europe. Mundus Mini is in the process of validation/testing. We have placed it in one beta site in Israel, and have identified a few other sites in Europe and the U.S.
Q: How much does it cost?
A: It will be much more affordable than current automation. Connect with your local distributor.
Q: What are the commercial models for buying a Mundus? Can we lease it?
A: Speak to your local distributor.
Q: Â Why are you not selling the EQUASHIELD Pro anymore? Can I still buy the EQUASHIELD Pro?
A: EQUASHIELD decided to go with a more ‘modular’ approach that can be used in almost any facility without having to buy new equipment, break the cleanroom, hire dedicated technicians, etc. Much more efficient, budget-friendly, and less labor-intensive.
We will continue to support the current EQUASHIELD Pros in the market. The EQUASHIELD Pro is no longer available for purchase.
Service & Maintenance #
Q: What is the warranty/ service plan?
A: 1-year warranty, will have multiple-tiered service plans ranging from basic coverage to more extensive service.
Note that the service should be minimal, with easy-to-replace parts.
In the future, we hope to implement machine health monitoring that will essentially monitor the machine and identify any potential for malfunction before it happens.
Q: How often do I need to calibrate/ perform maintenance?
A: No calibration needed. An automatic self-calibration will happen after each login and/or restart.