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Frequently Asked Questions

SmartCompounders

    What are the exact dimensions of the SmartCompounders machine? (Width x Depth x Height)

    The standard version of the SmartCompounders machine comes with 10 stations and has the following dimensions: 1100 × 400 × 630 mm. This is the preferred version to maximize throughput, but if needed, the machine can also be customized to a compact, shorter version with a minimum of 5 positions that has dimensions of: 650 × 400 × 630 mm.

    What is the voltage, frequency and sound level?

    230 V @ 50 Hz ; ≤ 65 dB(A).

    How does the robot enable elimination of patient and medication errors, as well as a seamless process?

    SmartCompounders has 2 cameras – and external and an internal camera. External camera: before loading the materials each drug, patient carrier and attached grippers with QR adaptors are scanned to merge the item to the gripper. Internal camera: when the batch starts, the internal camera located on the robotic head scans the QR codes of all the drugs and patient grippers to identify their exact station locations. This process prevents drug error, dose mixing and labelling errors.

    Can the robot handle doses of 1ml, 5ml and 10ml?

    It is recommended to use the robot for dosages higher than 5ml. For less than 5ml, there could be larger deviations (more than 5%). The SmartCompounders machine is primarily intended for large, repetitive volumes. Also, small volumes can be done very quickly by working manually.

    What is SmartCompounder’s accuracy +/- ?

    SmartCompounders features high accuracy:
    85.74% for Dev<1%
    9.82% for 1%≤Dev<2%
    3.74% for 2%≤Dev<3%
    0.71% for Dev≥3%
    *Deviation over 5%, 0.6% of total production.

    Is drug vial identification done by barcode scanning? If so, how does the machine know that the carrier is holding the correct drug vial?

    During the drug loading process, the drug vial is identified by the image recognition camera by means of specified keywords on the drug label. Then each drug is merged by the QR barcode located on the gripper holding it. In this way, any specific drug position is understood by the robot after additional scanning by the internal robotic head camera.

    How does the SmartCompounder machine operate?

    The SmartCompounders process injects preps in parallel per drug:

    After station scanning, the robotic head, holding a transfer syringe, extracts the amount needed from the drug vial.

    The drug is injected into all carriers that require this specific drug in parallel.

    The robot then places the transfer syringe for the first drug into the syringe holder. It then takes another transfer syringe for the next drug and injects it into the required
    carriers etc.

    Is it necessary to place the preparations in a specific order?

    No. the internal camera verifies the exact location of each preparation so the drugs and patient containers can be placed randomly at any desired station.

    Can the SmartCompounders machine reconstitute powders?

    No. There is no direct reconstitution of powders. The SmartCompounders machine is intended to optimize efficiency, and reconstitution is time consuming. Reconstitution can be done manually and then loaded onto the machine.

    Can the SmartCompounders machine perform Ad volume (removing carrier for specific volume in bag)?

    Yes. The SmartCompounders machine can do drug injection following withdrawing of carrier solution from IV bag.

    How many drugs can be used in the same batch?

    The robot can handle up to 4 different drugs in one batch.

    Which Chemfort® disposables can be used?

    The robot can use all Chemfort® products: Vial Adaptor, Syringe Adaptor Lock, Bag adaptor SP, Bag Adaptor CP, Bag Adaptor LL, Spike Port Adaptor etc.

    Which transfer syringe is used to transfer the drugs to the carriers?

    Codan 60ML is used.

    Assuming the 10 station system is ordered, can it be changed to a 5 station system later?

    Once the SmartCompounders system is installed, the stations can’t be modified. The number of stations has to be defined prior to installation.

    Can SmartCompounders integrate with a hospital EMR system?

    Yes. Several IT discussions will be required to determine the complexity of the integration.

    Is gravimetric weighting done on the vial adaptor side or the final container side, or on both?

    Gravimetric weighting is done on the final container side (front side of the SmartCompounders system) by measuring the delta before and after drug injection.

    What tools are needed for maintenance by the hospital?

    All maintenance tools will be provided with the SmartCompounders system. Support will be done on-site, as well as remote support by Simplivia / SmartCompounders team / third party.

    How is the SmartCompounders system installed?

    SmartCompounders is very quick and easy to install. The machine fits through narrow doors (maximum dimensions 1100 × 400 × 630 mm). It can be installed in existing LAF / isolator without having to invest in a cleanroom. The installation period is 3 to 4 days, including IQ and OQ. 2 days are needed for operator training.

    What is the cleaning and maintenance procedure for the SmartCompounders system?

    The SmartCompounders machine is easy to clean and decontaminate. It is resistant to common cleaning and disinfecting agents. Cleaning time is 15 to 20 minutes. SmartCompounders features highly sustainable compounder parts (e.g. AISI 304 / 316, PETP). 1 preventive maintenance visit per year is required (duration 1 to 2 days). In addition, compounder parts are replaced easily if needed.

    Chemfort® - Closed Administration

      What is Chemfort®?

      Chemfort® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

      How do Chemfort® components connect to each other?

      Chemfort® has a diverse portfolio that is tailored to your clinical needs, adapting to hazardous drug vials, syringes, IV containers and administration sets. With a simple "click", any two Chemfort® components can easily connect and safely disconnect.

      What is Chemfort® Closed Administration?

      Chemfort® Closed Administration is a closed administration components portfolio designed to ensure the health and safety of nurses. Chemfort® Closed Administration components protect against hazardous drug leakage and the escape of aerosols and vapors that can occur during drug administration. The component firmly connects between a standard IV bag or semi-rigid container and any IV administration set (gravity or pump). Using the components minimizes the risk of exposure to hazardous drugs for nurses, and resulting negative health effects. Safe drug containment also minimizes environmental contamination. In addition, Chemfort® Closed Administration components eliminate the risk of needle stick injuries.

      How do Chemfort® and Chemfort® Closed Administration Work Together?

      Chemfort® Closed Administration components and Chemfort® Closed System Drug-Transfer Device components share the same connections, which incorporate the Chemfort® elastomer sealing ports, enabling them to be connected. The self-sealing elastomers on the outer septa surfaces prevent drug leakage and droplets.

      For example, in the pharmacy: inject a drug using Chemfort® Syringe Adaptor into the Chemfort® Bag Adaptor CP port spiked into an IV bag.

      Or, for example, in the ward: A Chemfort® Closed Adaptor SP connected to a standard IV administration set will connect the Chemfort® Bag Adaptor CP component that is spiked in the IV bag.

      What is Toxi-Guard®?

      Toxi-Guard® is Simplivia's patented air-cleaning technology. This unique technology located inside the Chemfort® Vial Adaptor is a patented double membrane system. It is comprised of two layers: one is an activated carbon matrix, which functions as a hazardous drug adsorbant, and the second layer is a 0.2 micron hydrophobic and oleophobic membrane which functions as a sterile barrier for external air. Due to these Toxi-Guard® characteristics, the Chemfort® Closed System Transfer Device (CSTD) keeps the user safe while working with hazardous drugs, and keeps the drug sterile.

      What are the Chemfort® system component SKUs?

      Each Chemfort® component has a unique code (SKU). The majority of hazardous drug compounding can be done with just three SKUs, designed to reduce waste, help make implementations easier and reduce confusion.

      What are the Chemfort® Closed Administration Component SKUs?

      Chemfort® Closed Administration can be used in many different ways with just 4 components. This results in significant benefits in cost-savings and storage. The limited number of components also prevents user error and mistakes on the ward. Chemfort® Closed Administration SKUs are:

      • MG245252 - Bag Adaptor CP
      • MG245254 - Bag Adaptor SP
      • MG245255 – Closed Secondary IV Set
      • MG245253 - Closed Y Inline Set
       

      Will Chemfort® fit all bags/infusors/IV containers and syringes?

      Chemfort® Bag Adaptor SP/LL and Chemfort® IV Safety Set will fit any spike port and connect distally to any luer lock connection set. Chemfort® Syringe Adaptor and Syringe Adaptor Lock fit all standard luer lock syringes.

      How can Chemfort® fit all your connection needs?

      With a low number of SKUs, Chemfort® is designed to fit all connection types from spike to luer lock connections, either on the port side or at the end of a set or on the patient's side.

      Do you have administration sets available in the portfolio?

      Yes, Simplivia has different administration sets in addition to Chemfort® Closed Administration products that can fit your requirements. Please see our product line.

      How does the Toxi-Guard® mechanism maintain safety?

      The Chemfort® mechanism which is located inside the Chemfort® Vial Adaptor is adjacent to the air pathway thereby preventing the escape of drug vapors and aerosols from within the vial and sterilizing the air entering the vial.

      What are the 0.2 micron membrane characteristics?

      The pore size of the membrane in the Toxi-Guard® filter is 0.2 micron. This membrane is both hydrophobic and oleophobic, thus preventing any hazardous drug droplets from passing through to the outside. Furthermore, the membrane sterilizes air entering the vial.

      What are the charcoal matrix characteristics?

      The charcoal matrix is made of activated carbon, which acts as a hazardous drug vapor adsorber, preventing the escape of hazardous drugs from within the vial to the outside.

      Is the drug and/or air filtered by the Toxi-Guard® system?

      The drug fluid is blocked by the Toxi-Guard® system and is not filtered by it. The air that is passing through the Toxi-Guard® system is filtered.

      What is the needle bore diameter in the Chemfort® Syringe Adaptor?

      The needle bore size of the Chemfort® Syringe Adaptor needle is 16G.

      What materials are the Chemfort® components made of?

      Please refer to the data sheets of each component in our Chemfort® product pages.
       

      Is Chemfort® latex-free?

      Yes, all the components in the Chemfort® Closed System Transfer Device (CSTD) portfolio are free of latex. Chemfort® components are also non-pyrogenic and free of DEHP, lead, cadmium, arsenic and chrome.

      Does Chemfort® contain DEHP?

      No. All Chemfort® Closed System Transfer Device (CSTD) components are DEHP-free. Chemfort® components are also non-pyrogenic and free of latex, lead, cadmium, arsenic and chrome.

      Is Chemfort® PVC-free?

      Most components in the Chemfort® portfolio are PVC-free. The Chemfort® IV Safety Set and Chemfort® IV Safety Set 0.2 Micron Membrane are not PVC-free .

      Is Chemfort® sterile?

      Yes, all Chemfort® Closed System Transfer Device (CSTD) components are sterile. Chemfort® is sterilized by using Ethylene Oxide (EtO).

      What is the Chemfort® shelf-life?

      The shelf life of Chemfort® components is 3 years. The expiry date is indicated on each single unit package and on each box.

      How are Chemfort® components packaged?

      All Chemfort® CSTD components are individually packaged as a single unit, with a specific number of components per box.

      What is the added value of the Chemfort® Closed Administration portfolio?

      Chemfort® Closed Administration devices allow repeatable use with the same Closed Administration Set, with up to 10 activations (connections and disconnections).

      Is drug sterility maintained when using Chemfort® repeatedly?

      The ability of Chemfort® to maintain solution sterility within a vial was tested in 80 vials for 30 days with repeated sampling. Testing showed 100% maintenance of sterility over the tested period.

      Has Chemfort® been tested according to the 2016 NIOSH draft protocol for containment of hazardous drugs?

      Yes. Chemfort® has been tested using one of the proposed drug surrogates (2-Phenoxy ethanol) in the NIOSH draft protocol, demonstrating excellent performance with non quantifiable levels of contamination (below LOQ). This is true for fresh products, as well as products at the end of their shelf life.

      Can vials with a Chemfort® Vial Adaptor attached be stored in the refrigerator?

      Yes. Chemfort® Vial Adaptor can be stored for an extended time after preparation. Refer to Chemfort® Instructions For Use (IFU) for details on Vial Adaptor usage instructions. Comply with drug manufacturer instructions regarding drug stability.

      How did you determine that Chemfort® can be used with all hazardous drugs?

      We identified the hazardous drugs with the most aggressive and challenging solvents. These solvents were used to test Chemfort® vial adaptor and syringe adaptor in a 7 day study. The study showed that during a contact period of 7 days the Chemfort® products maintain their structural integrity and functionality.

      How do you know that Chemfort® functions well at the end of its expiry date (3 years)?

      Several studies tested the functionality of Chemfort® at the end of the expiry date. Specifically we tested:
      1.The efficacy of the Toxi-Guard® in preventing leaks of hazardous drugs vapor and aerosols
      2.The total containment of 3 years Chemfort® product in preventing release of drug surrogate solution, vapor and aerosol
      3.The compatibility of Chemfort® with all known hazardous drugs.

      Has Chemfort® been proven to provide cost advantages?

      Chemfort® has been tested and proven to maintain sterility for up to 28 days (see "Chemfort® 10 Activations Challenge" in Chemfort Publications & Resources). Additionally, Chemfort®'s predecessor product line was tested vs. needle and syringe and was demonstrated to deliver economic savings over the latter (see "Responding to drug shortages and rising costs: IV chemotherapy drug use" in Chemfort Publications & Resources.

      Does Chemfort® offer a solution for closed administration?

      A closed administration is achieved by connecting different Chemfort® components. For example: Luer Lock Adaptor to the patient's port and a Chemfort® Syringe Adaptor / Syringe Adaptor Lock at the end of an IV set.
      Chemfort® Bag Adaptor CP to an IV bag and the Chemfort® Closed Adaptor SP which connects to the Chemfort® Bag Adaptor CP port from one side and spiked on any standard primary line from its tail side.

      How can I use Chemfort® to fill elastomeric disposable infusers?

      Chemfort® can be used to fill an elastomeric pump by connecting a Chemfort® Luer Lock Adaptor onto the infuser and injecting the drug using a Chemfort® Syringe Adaptor.

      How can I be certain that Chemfort® components are connected correctly?

      Chemfort® components are easy to connect. Simply click the Chemfort® Syringe Adaptor to any Chemfort® port and the audible click verifies a safe connection.

      Does using Chemfort® require extensive training?

      No. Chemfort® is intuitive, simple to use and requires minimal training due to its easy component connection.

      How can I prevent needle stick injuries?

      The needle is hidden inside the Chemfort® Syringe Adaptor/Syringe Adaptor Lock elastomer and is only extracted upon clicking to another Chemfort® component, such as a Vial Adaptor, Luer Lock Adaptor etc. There is no risk of needle exposure with Chemfort® if the product is handled as described in the Chemfort® Instructions For Use (IFU).

      Can I connect Chemfort® Vial Adaptor to drug ampules?

      The Chemfort® Vial Adaptor cannot be connected to an ampoule. Therefore, it is not possible to work with a Closed System Transfer Device.

      How do I dispose of Chemfort® products?

      Chemfort® components should never be disconnected from the vial, syringe, IV container or IV set in order to maintain a closed system during waste disposal. Follow your local guidelines for waste disposal for hazardous drugs.

      How do I get rid of air bubbles in the syringe?

      Small air bubbles can form in the Chemfort® syringe while withdrawing drug from the vial. These bubbles can be released from the syringe while the Chemfort® Syringe Adaptor and Chemfort® Vial Adaptor are still connected to each other. They should be inverted so that the syringe is positioned below the vial and air bubbles can then be pushed upwards gently. Liquid should not be pushed back into the vial in this position.

      Will using Chemfort® slow down our production rates?

      Chemfort® has been designed to be intuitive, requiring a very short training time initially and later on enabling you to work at your normal rate.

      Does the Chemfort® Vial Adaptor require pre-priming or extra steps before using it?

      There are no preparation steps needed before working with Chemfort®.

      Can vials with a Chemfort® Vial Adaptor attached be stored in the refrigerator?

      Yes. The Chemfort® Vial Adaptor can be stored for an extended time after preparation. Refer to Chemfort® Instructions For Use (IFU) for details on Vial Adaptor usage instructions. Comply with drug manufacturer instructions regarding drug stability.

      What are the Chemfort® storage conditions?

      Chemfort® closed system transfer device components do not require special storage conditions. Keep the Chemfort® components in a cool and dry place (room temperature).

      Is Chemfort® cleared by the FDA?

      All of the Chemfort® devices have been cleared under the ONB product code. This includes Chemfort® adaptors,  Chemfort™® sets and Chemfort® Closed Administration.

      What is the FDA ONB clearance?

      The FDA product code ONB is specific for 510(k) clearance of CSTD systems of any technology. By definition, this code is for devices that reconstitute and transfer antineoplastic and other hazardous drugs in healthcare settings indicated to reduce exposure of healthcare personnel to chemotherapy agents.

      Does Chemfort® have a CE marking?

      The following items in the Chemfort® product family have received a CE marking (CE0483): Chemfort® Luer Lock Adaptor, Chemfort® Bag Adaptor SP, Chemfort® Vial Adaptor (various sizes), Chemfort® Syringe Adaptor and Chemfort® Syringe Adaptor Lock; as well as the following sets: Chemfort® Bag Adaptor LL, Chemfort® Bag Adaptor LL (with female luer), Bag Adaptor LL PVC Free, Chemfort® IV Safety Set, Chemfort® IV Safety Set (with 0.2 Micron filter) and Chemfort® IV Safety Set PVC Free.

      Is there an existing patent on the Chemfort® system?

      Yes. Please refer to our patents information page.

      Have Chemfort® Closed Administration products been proven to provide protection against the escape of hazardous aerosols and vapors?

      Yes. Simplivia's Chemfort® Closed Administration system has been proven to provide protection against the escape of hazardous aerosols and vapors that can occur during drug administration in a NIOSH-based test standard. In this test protocol, Simplivia evaluated and tested the Chemfort® Bag Adaptor CP, Chemfort® Closed Adaptor SP, Chemfort® Closed Y Inline Set, and Chemfort® Closed Secondary IV Set.

      Veterinarians

        Why is Chemfort® Important for Veterinarians?

        The average veterinary practice has over two hundred hazardous drugs in inventory at any given time, including chemotherapy drugs. Veterinarians face the risk of direct exposure to these antineoplastic drugs. This exposure can put veterinary clinic staff, animal owners and anyone who comes into the practice at risk. Repeat exposure to hazardous drugs has been shown to lead to adverse health effects including increased risk of developing certain types of cancers. As a closed, safe drug delivery solution, Chemfort® enables veterinarians to reduce exposure risk when handling cytotoxic drugs.

        What Guidelines Exist for the Use of CSTDs in Veterinary Practice?

        To ensure safe practice and reduce exposure, guidelines and regulations have been issued by professional associations including the National Institute for Occupational Safety and Health (NIOSH), the American College of Veterinary Internal Medicine (ACVIM) and the American Animal Hospital Association (AAHA). These guidelines include recommendations for the use of Closed System Drug-Transfer Devices (CSTDs) like Chemfort® in combination with personal protective equipment (PPE), proper staff training, and appropriate waste management procedures. The guidelines are intended to protect the health of the animals being treated and the healthcare professionals involved in their care.

        Why Do Veterinarians Need Increased Awareness of the Risk of Hazardous Drug Exposure?

        Unlike chemotherapy treatment in human medicine, veterinarians who provide oncology services are involved in all stages of chemotherapy treatment – this includes compounding cytotoxic drugs, transporting them administration and drug disposal. Exposure to hazardous drugs can occur at any of these stages. It can also occur while cleaning spills or touching contaminated surfaces. Contact with hazardous drugs can happen through contact with bedding, cages or animal waste. As a result, veterinarians should be aware of the risks of occupational hazardous drug exposure, and equipment available to handle hazardous drugs safely.

        How Can Veterinarians Protect Themselves by Using Chemfort®?

        Chemfort® provides an end-to-end complete portfolio of closed drug administration products. The Chemfort® product family demonstrates scientifically validated performance to protect veterinarians, veterinary clinic staff, as well as animal owners from exposure to antineoplastic drugs. When using Chemfort®, veterinarians can ensure a safe, closed connection that reduces the risk of exposure to hazardous chemotherapy drugs at every stage from preparation and compounding through to administration and disposal.

        When Providing Oncology Services, What Should Veterinarians Use in Addition to Closed System Drug-Transfer Devices (CSTDs) to Safely Handle Hazardous Drugs?

        To minimize the risk of exposure to hazardous drugs, veterinary practices should implement comprehensive safety protocols. This includes establishing appropriate facilities and equipment, providing specialized training to staff, and enforcing strict adherence to safety guidelines. Key precautions include the use of proper PPE (e.g., gloves, gowns, masks, and eye protection), engineering controls (e.g., ventilation systems), safe handling and disposal practices. Veterinarians and veterinary technicians should also receive proper training on safely handling, preparing, administering, and disposing of hazardous drugs.

        How Does Simplivia’s Toxi-Guard® Technology Protect Veterinarians?

        Simplivia’s Chemfort® CSTD product line is empowered by the unique Toxi-Guard® patented air-cleaning technology. Toxi-Guard® is Simplivia's patented air-cleaning technology. This unique technology located inside the Chemfort® Vial Adaptor is a patented double membrane system. It is comprised of two layers: one is an activated carbon matrix, which functions as a hazardous drug adsorbant, and the second layer is a 0.2 micron hydrophobic and oleophobic membrane which functions as a sterile barrier for external air. Due to these Toxi-Guard® characteristics, the Chemfort® Closed System Transfer Device (CSTD) keeps the user safe while working with hazardous drugs, and keeps the drug sterile.