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Frequently Asked Questions

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, Chemfort™ IV Safety Set 0.2 Micron Membrane and Chemfort™ 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 components enable set conservation and reuse. The components allow the option of reusing a single Closed Secondary IV set / Y-Line / Primary line for all cytotoxic drugs with up to 10 connections / 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 pimary 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.