Frequently Asked Questions

Chemfort™
Tevadaptor^®

Chemfort™

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", two Chemfort™ components can easily connect and safely disconnect.

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 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.

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, we have different administration sets that can fit your requirements. Please see our products.

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 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™ 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™ 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™ 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 components are individually packaged as a single unit, with a specific number of components per box.

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 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.

Does Chemfort™ offer a solution for closed administration?

A closed administration is achieved by connecting a Chemfort™ Luer Lock Adaptor to the patient's port and a Chemfort™ Syringe Adaptor/Syringe Adaptor Lock at the end of an IV set.

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 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 Closed System Transfer Devices.

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 Chemfort™ 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™ does not require special storage conditions. Keep the Chemfort™ components in a cool and dry place (room temperature).

Is Chemfort™ cleared by the FDA?

The following items in the Chemfort™ product family have received FDA 510(k) clearance under ONB product code: Chemfort™ Luer Lock Adaptor, Chemfort™ Bag Adaptor SP, Chemfort™ Vial Adaptor (various sizes), Chemfort™ Syringe Adaptor and Chemfort™ Syringe Adaptor Lock.

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.

Tevadaptor^®

What is Tevadaptor®?

Tevadaptor^® 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 Tevadaptor® components connect to each other?

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

What is Toxi-Guard®?

Toxi-Guard^® is Simplivia™'s patented air-cleaning technology. This unique mechanism located inside the Tevadaptor^® 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 Tevadaptor^® Closed System Transfer Device keeps the user safe while working with hazardous drugs.

What are the Tevadaptor® system component SKUs?

Each Tevadaptor^® component has a unique code (SKU). Refer to specification sheets on our resource center.

Will Tevadaptor® fit all bags/infusors/IV containers?

Tevadaptor^® Spike Port Adaptor (SPA) and Tevadaptor^® Connecting Set (CS) will fit any spike port and connect distally to any luer lock connection set.

Will Tevadaptor® fit all syringes?

Tevadaptor^® Syringe Adaptor and Syringe Adaptor Lock fit all standard luer lock syringes.

How can Tevadaptor® fit all your connection needs?

With a low number of SKUs, Tevadaptor^® 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, we have different administration sets that can fit your requirements. Please see our products.

How does the Toxi-Guard® mechanism maintain safety?

The Toxi-Guard^® mechanism which is located inside the Tevadaptor^® 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 0.2 micron membrane is both hydrophobic and oleophobic, thus preventing any 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 filtered by the Toxi-Guard® system?

No. The drug fluid is blocked by the Toxi-Guard^® system and is not filtered by it.

Is the air filtered by the Toxi-Guard® system?

Yes, the air that is passing through the Toxi-Guard^® system is filtered.

What is the pore size of the membrane in the Toxi-Guard® filter?

The pore size of the membrane is 0.2 micron.

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

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

What materials are the Tevadaptor® components made of?

Please refer to the data sheets of each component in our resource center.

Is Tevadaptor® latex-free?

Yes, all the components in the Tevadaptor^® portfolio are free of latex.

Does Tevadaptor® contain DEHP?

No. All Tevadaptor^® components are DEHP-free.

Is Tevadaptor® sterile?

Yes, all Tevadaptor^® components are sterile.

How is Tevadaptor® sterilized?

Tevadaptor^® is sterilized by using Ethylene Oxide (EtO).

What is the Tevadaptor® shelf-life?

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

How are Tevadaptor® components packaged?

All components are individually packaged as a single unit, with a specific amount of components per box.

How does the 0.2 micron membrane in the Toxi-Guard® sytem work?

The 0.2 micron hydrophobic and oleophobic membrane has two main purposes. It is highly effective in blocking particles, droplets and microorganisms. It also acts as a sterile barrier, preserving the drug from being contaminated by external contaminants.

How does the charcoal matrix in the Toxi-Guard® work?

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.

What drug stability data does Tevadaptor® have?

Stability of over 10 common hazardous drugs has been tested using Tevadaptor^®. Tests were performed in various drug containers, including: syringes, vials or IV bags. All drugs were stable in the tested time periods. To learn more, please refer to our publications.

Is drug sterility maintained when using Tevadaptor® repeatedly?

The ability of Tevadaptor^® to maintain solution sterility within a vial was tested in over 300 vials for 28-days with repeated sampling. Testing showed 100% maintenance of sterility over the tested period. Please read more here.

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

Yes. Tevadaptor^® has been tested using 2 of the proposed drug surrogates in the draft protocol, demonstrating excellent performance with non quantifiable levels of contamination (below LOQ). Learn more here.

What data is available for using Tevadaptor® with monoclonal antibodies (mAbs)?

Tevadaptor^® has been tested with Trastuzumab (Herceptin). Results showed maintenance of physico-chemical stability, full functionality as well as sterility of this biologic drug.

Does Tevadaptor® offer a solution for closed administration?

A closed administration is achieved by connecting a Tevadaptor^® Luer Lock Adaptor to the patient's port and a Tevadaptor^® Syringe Adaptor/Syringe Adaptor Lock at the end of an IV set.

How can I prime the Tevadaptor® Spike Port Adaptor when attached to the bag?

In order to prime the Tevadaptor^® Spike Port Adaptor (SPA), it has to be connected to the infusion set first. The SPA will then be primed at the same time as the infusion set. For a safe connection, the next steps should be followed: insert the spike of the SPA to the spike port of the bag and close the clamp of the SPA. Take off the twist-off connector at the distal end of the SPA (due to the integrated safety diaphragm and the closed clamp, there is no risk of fluid escaping). Insert the spike of the infusion set into the Spike Port Adaptor and then open the clamp to prime the set as local guidelines prescribe.

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

Tevadaptor^® can be used to fill an elastomeric pump by connecting a Tevadaptor^® Luer Lock Adaptor onto the infuser and injecting the drug using a Tevadaptor^® syringe adaptor.

How will Tevadaptor® work with my usual electronic infusion pump on the ward?

By connecting the standard or specific pump sets to the Tevadaptor^® Spike Port Adaptor or Connecting Set.

How can I prevent needle stick injuries?

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

Can I connect Tevadaptor® Vial Adaptor to drug ampules?

The vial adaptor cannot be connected to an ampoule. Therefore, it is not possible to work with Closed System Transfer Devices.

How do I dispose of Tevadaptor® products?

Tevadaptor^® components should never be disconected 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 Tevadaptor^® syringe while withdrawing drug from the vial. These bubbles can be released from the syringe while the syringe adaptor and 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.

Can Tevadaptor® be used for bladder instillation?

For bladder instillation the Tevadaptor^® Catheter Adaptor should be used. It connects to any standard Foley catheter allowing safe drug administration directly to the urinary bladder.

Will using Tevadaptor® slow down our production rates?

Tevadaptor^® 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 Tevadaptor® require pre-priming or extra steps before using it?

There are no preparation steps needed before working with Tevadaptor^®.

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

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

What are the Tevadaptor® storage conditions?

Tevadaptor^® does not require special storage conditions. Keep the Tevadaptor^® components in a cool and dry place (room temperature).

Is Tevadaptor® FDA cleared?

Yes, Tevadaptor^® received FDA 510(k) clearance under ONB product code (K141448) in 2014.

What is the FDA ONB clearance?

The FDA product code ONB is specific for 510 (k) clearance of CSTDs 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 Tevadaptor® have a CE marking?

Yes, Tevadaptor^® has a CE mark (CE0483).

Is there an existing patent on the Tevadaptor® system?

Yes. Please refer to our patents information page.