What is the size and weight of the Mundus Mini HD? #

	Mundus Mini	Control Unit
Height	65 cm	58 cm
Width	100 cm	25 cm
Depth	45 cm	45 cm
Weight	45 kg	20 kg

What size biological safety cabinet do I need? Minimum requirements of the BSC? #

• It should be able to fit within a standard cabinet that is 1.3m (4ft) long.
• PEC should be ISO class 5 (Grade A)
• BSC should be able to withhold 50kg

Do you have any partnerships with hood companies? #

We are in the process of developing relationships. We have partnered with NuAire in the U.S. and hope to have a partner in Europe as well.

Can the Mundus Mini HD be used in an isolator? #

The current design is not compatible with an isolator. We are looking into modifying to be compatible with isolators.

Do we have to use your CSTDs? #

Yes. The machine’s design and operation were built around the EQUASHIELD® CSTD capabilities and features.

Using the EQ CSTD can offer many additional advantages such as:

• Safety, especially with our unique closed back syringe unit
• 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 uniform consumables because otherwise constant calibration and adjustments are needed. Might as well use a consumable that is also offering you protection against hazardous drugs.

What EQUASHIELD® CSTDs will it work with? #

• All syringe unit sizes with ‘new’ outer female
• SA-EZ
• SA-EZ/D
• SA-EZ/ST
• SA-EZ/E
• SA-EZ/F
• (SA-EZ/W?)
• VA-13, VA-13C
• VA-20, VA-20C
• (LL-2S soon)
• SA-180 – not currently compatible, TBD.

What kind of preparations will it make? #

IV bags and syringe preparations only. We will perform testing to see if we can incorporate elastomeric pumps and semi-rigid bottles in the near future.

What kind of vials and IV bags does it work with? #

It 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 with labels that 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

• What is the speed? (preps/hr)

What is the speed? (preps/hr) #

As part of the validation, we are testing the Mundus Mini production rate. The device is intended to compound on average 20 preparations per hour.

Does it work with semi-rigid bottles (ecoflac)? #

Currently, it is not compatible. We are currently exploring potential solutions.

Does it work with drugs with high viscosity? MABs? #

Yes. We are in the process of validation. The Mundus Mini HD Should be able to work with most drugs that can be manually compounded using the EQUASHIELD® system. There may be some exceptions, but we will know more once it is operational in beta sites.

Are there any hazardous drugs that it cannot compound? #

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 the EQUASHIELD® system.
• 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.
• Drugs with specific manufacturer instructions that conflict with the Mundus Mini should not be used (ex: diluent should be directed at the vial wall and not powder directly).

Can the Mundus Mini HD do reconstitution? #

Yes. Note that reconstitution is a separate function from compounding. It will not reconstitute and then compound automatically. It requires the operator to perform a visual inspection of the reconstituted vial before using it in compounding. Compounding is performed under a separate tab/workflow.

How many preparations can it do at a time? #

Only one preparation at a time.

Can it do batch preparations? #

No. It can prepare individualized preparations, one at a time.

What happens if a drug runs out during the compounding process? #

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.

Can it compound a dose with multiple vials? #

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).

Why are there 3 IV bag stations? #

The 3 stations allow for flexibility in different circumstances. Some options:

• Final IV bag (for preparation)
• Diluent IV Bag
• In the future: can have a ‘waste bag’ for equal volume preparations, can interchange a spike station for a luer station when the feature is available

What is in the documentation (order report)? #

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 compounding process.

*Note the current documentation has certain data as images and not text (expiration, lot #, manufacturer). We hope to have this data as text in the future.

Where is the printer? #

There is no printer in the Mundus Mini HD. The order labels are supplied by the facility. The only requirement from the Mundus Mini HD is that it has the order 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.

Where is it working? Is it in a beta site? #

We are just starting the ‘soft launch’ in Europe. Mundus Mini HD is in the process of validation/testing. We have placed it in one beta site in Israel (Tel Hashomer), Poland, and Germany and have identified a few other sites in Europe and the U.S.

When will it be available for purchase? #

TBD. Connect with your local distributor for more information.

How much does it cost? #

It will be much more affordable than current automation. Connect with your local distributor.

What are the commercial models for buying a Mundus Mini HD? Can we lease it? #

Speak to your local distributor.

What makes it better than competitors? #

• 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 training process very simple
• No calibration is needed; no real maintenance is needed

Will using it change my current workflow? #

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.).

*Note: the U.S. version might require a different workflow. TBD.

Will my staff have to be trained to use it? #

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.

What is the warranty/ service plan? #

1-year warranty is covered.

We have a 3-tiered service plan (basic, medium, and white glove service) ranging from basic coverage to more extensive service.

24/6 call center that should be able to manage most troubleshooting. If a technician is needed, they will arrive onsite within 1 business day.

Note that the service should be minimal, with easy-to-replace parts.

(We hope to implement machine health monitoring in the future that will essentially monitor the machine and identify any potential for malfunction before it happens.)

How often do I need to calibrate/ perform maintenance? #

No calibration is needed. An automatic self-calibration will happen after each login and/or restart.

What is the installation process like? #

Installation is a relatively simple process compared to standard automation.

• Software integration + testing: performed before shipping the device. (Multiple meetings/exchanges with hospital IT, EMR IT, and EQUASHIELD® to determine the integration process. The process can take days to months depending on the EMR capabilities.
• Mundus Mini HD will be calibrated and validated in EQUASHIELD® facility (IQ, OQ processes)
• An EQUASHIELD® technician will arrive with the machine to assist with the installation
• Minimal testing performed in the facility before use (PQ process, more simplified)
• 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)

Why are you not selling the EQUASHIELD® Pro anymore? Can I still buy the EQUASHIELD® Pro? #

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.

Can the machine replace a pharmacist/ technician?  #

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.

What are the software requirements? #

• Intel 4-cores
• 8 Gb RAM
• Hard disk – 500Gb
• Windows server 2019
• Internet connection

What is software integration like? #

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.

Is the software communication bidirectional? #

We provide the relevant data to InterSystems. It depends on the hospital’s EMR on what data they can receive in return.

Can a supervisor or someone outside the clean room verify the compounding as it is happening (see the process)? #

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. (This may change so that we will create an option that someone outside the clean room can see the process. TBD)

Can I see the test report before it’s sent back to the EMR? #

Currently, no. The prescription report will be sent automatically as soon as the compounding is complete.

What is the safety/encryption used to protect sensitive data? #

The software complies with all regulatory requirements regarding the protection of sensitive data (such as HIPAA 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.

Can you provide analytical data such as preparation logs and stock management? #

Currently, no. We only provide info directly related to the compounding process. Perhaps in the future.

What standards does the Mundus Mini HD meet? (Regulatory) #

• 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.

Have you tested the airflow in the hood with the Mundus Mini HD? #

Yes. We have utilized multiple third parties to test the airflow.

What is the accuracy? How do we achieve accuracy? #

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).

Does it have gravimetric verification?  #

No. Mundus Mini HD 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 HD will be validated and compared to gravimetric accuracy.

What are the clean room requirements? #

ISO class 7 (Grade B/C)

Can I compound outside of the cleanroom using the Mundus Mini? (or suboptimal conditions?) #

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.

Does your software comply with 21 CFR part 11? #

Yes.

What is the smallest dose that can be compounded? #

We are finalizing the testing/validation to confirm. Currently, 0.3ml is the smallest dose.

I see a lot of moving parts. Is it safe for the user? #

: 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.

What is the cleaning process like? What materials? How often? #

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

How do I do a deep clean of the hood with the machine? #

Most likely, you will be required to take out the machine. We are in the process of developing potential different solutions to make it easier to take out the hood. TBD.

Can I buy a Mundus Mini HD to use for antibiotics (non-hazardous)? #

The Mundus Mini HD is intended use is to work with hazardous drugs.