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Chemfort® Closed System Drug Transfer Devices (CSTD)

At Simplivia, we focus on your safety so you can focus on what really matters. Please use the following overview to learn how Closed System Transfer Devices (CSTD) can help protect pharmacists, nurses and veterinarians in the healthcare workplace.

What is a Closed System Drug Transfer Device (CSTD)?

A Closed System Drug Transfer Device (CSTD) is a medical device designed to mechanically prevent the transfer of environmental contaminants into a drug system and the escape of hazardous drug vapors or liquids outside the system during drug preparation and administration.

The National Institute for Occupational Safety and Health (NIOSH), a key US health protection agency, recommends that CSTDs be used as part of a comprehensive hazardous drug safety program to reduce occupational exposure to hazardous drugs in healthcare environments.

CSTDs are used in pharmacy and clinical settings where hazardous drugs are prepared, transferred, and administered, helping to support safer handling practices for healthcare professionals.

    How CSTDs impact healthcare worker safety

    Healthcare professionals who work with hazardous drugs face ongoing exposure risks as part of routine clinical practice. These risks are not limited to antineoplastic chemotherapy drugs, but also apply to other medications with toxic, carcinogenic, or reproductive hazards including antibiotics and monoclonal antibodies. These drugs, while saving patient lives, can negatively impact the health of healthcare professionals.

    By maintaining a closed pathway during drug during compounding, reconstitution and administration, CSTDs help reduce unintended release of hazardous drugs into the healthcare environment, supporting safer working conditions for pharmacists, nurses, veterinarians, and other healthcare workers1.
    How CSTDs impact healthcare worker safety

      How healthcare professionals are exposed to hazardous drugs

      Exposure to hazardous drugs can occur at multiple stages during preparation and administration. This can include inhalation of drug vapors or aerosols, skin contact from spills or contaminated surfaces, accidental hand-to-mouth ingestion, needle-stick and sharps injuries, and environmental contamination affecting staff, patients, and caregivers.

      These exposure pathways highlight the need for closed drug delivery systems such as CSTDs, alongside personal protective equipment and established safety procedures.

        Why Closed System Drug-Transfer Devices are important

        As described above, handling hazardous drugs presents a persistent occupational risk in healthcare environments. While procedural controls and protective equipment are essential, they may not fully eliminate exposure during hazardous drug preparation, compounding, transfer and administration.

        Closed System Drug-Transfer Devices provide an additional layer of protection by limiting the escape of hazardous drugs, supporting safer workflows and aligning with best practices for hazardous drug handling.

          How CSTDs help reduce hazardous drug exposure

          CSTDs function by ensuring sealed connections between system components during drug preparation and administration. These sealed interfaces help reduce the release of hazardous drug vapors, aerosols, and liquids into the environment.

          By supporting closed workflows from vial access through drug administration, CSTDs help reduce the likelihood of occupational exposure and minimize surface contamination when used as part of established safety protocols.
          How CSTDs help reduce hazardous drug exposure

            Where CSTDs are used in healthcare workflows

            In pharmacy settings, CSTDs are used during hazardous drug preparation activities, especially when compounding, reconstituting and transferring drug from vials into syringes or IV bags. These steps can involve multiple connections and disconnections where exposure risk can increase.

              Chemotherapy and closed system transfer devices (preparation & administration)

              A closed system transfer device is used in chemotherapy to help reduce exposure risk during both preparation and administration, depending on workflow and dosage form.
              In oncology workflows, CSTDs help reduce the risk of aerosol/vapor release, leaks and drips during transfer, and surface contamination at connection points.
              Common use points of CSTDs in chemotherapy workflows include:

              • Preparation in the pharmacy (compounding/reconstitution, transfer to syringe or IV bag)
              • Administration in clinical areas when the dosage form allows (connection/disconnection during delivery to the patient).

                How the Chemfort® CSTD supports closed-system drug transfer

                The Chemfort® CSTD is designed to support closed connections during both drug preparation and administration workflows.

                Chemfort® meets the NIOSH definition. Chemfort® is also FDA cleared under the ONB product code and CE approved. Chemfort®’s performance is peer reviewed and acknowledged in leading journals and/or conferences.

                Chemfort® components are used across different stages of handling to help reduce exposure risks while aligning with applicable regulatory guidance. Additional details are available on the Chemfort® product page.

                  Where healthcare safety and simplicity meet

                  Simplivia provides closed system drug transfer devices and related solutions designed to support safer handling of hazardous drugs. Contact us for additional information.

                    Frequently Asked Questions (FAQ)

                      Regulatory guidance and standards for CSTDs

                      Key regulatory agencies worldwide publish regulations and guidelines related to the design and use of CSTDs, as well as the safe handling of cytotoxic materials. These include:

                      Using CSTDs enables healthcare professionals to adhere to these regulations and guidelines, and maintain safety when handling cytotoxic and other hazardous drugs.

                      Are CSTDs recommended or required by USP <800>?

                      USP <800> recommends the use of CSTDs when compounding hazardous drugs, and requires their use during the administration of antineoplastic drugs when the dosage form allows. This minimizes healthcare professional exposure in pharmacies and nursing and clinical areas.

                      CSTD in Pharmacy (USP <800> compounding workflow)

                      Under USP <800>, CSTDs are recommended when compounding hazardous drugs and are intended to work alongside engineering controls (as applicable), appropriate PPE, and facility SOPs and training.

                      Typical pharmacy touchpoints where a CSTD may be used include:

                      • Vial access and drug withdrawal
                      • Syringe preparation and transfers
                      • Transfer into an IV bag or infusion container
                      • Safe disconnection to help reduce leaks, aerosol/vapor release, and surface contamination.

                      What makes a CSTD compliant with NIOSH and FDA standards?

                      A CSTD is considered compliant when it meets the NIOSH definition, has appropriate FDA clearance, demonstrates independent performance data showing reduction of vapor or liquid release, and is used according to manufacturer instructions and facility procedures.
                      What makes a CSTD compliant with NIOSH and FDA standards?

                      How Are CSTDs Used in the Pharmacy?

                      In practice, Closed System Transfer Devices (CSTDs) are used in pharmacy compounding environments during the preparation of hazardous drugs to reduce occupational exposure and environmental contamination. CSTDs are applied at key steps such as vial access, drug reconstitution, transfer, and final dose preparation, maintaining a mechanically closed system that helps prevent the escape of hazardous drug vapors, aerosols, or droplets while protecting the sterile pathway. Their use is integrated with engineering controls, facility SOPs, and staff training, and is typically aligned with safety frameworks such as USP <800>, forming part of a layered approach to safe hazardous drug compounding.

                      How Are Closed System Transfer Devices Used in Chemotherapy?

                      In chemotherapy workflows, Closed System Transfer Devices (CSTDs) are used during the preparation and administration of antineoplastic drugs to help reduce occupational exposure and environmental contamination. For chemotherapy, the CSTD maintains a mechanically closed system during vial access, drug transfer, and connection to administration sets, helping limit the release of hazardous drug aerosols, vapors, and droplets while reducing the risk of leaks and surface contamination at connection points. Their use supports safe handling practices for hazardous drugs within oncology pharmacy and clinical administration settings 2.

                      What Is the Difference Between Using a CSTD in Preparation vs Administration?

                      Closed System Transfer Devices (CSTDs) are used at different stages of the hazardous drug workflow depending on whether the drug is being prepared or administered. Preparation typically occurs in the pharmacy, where CSTDs are used during compounding, reconstitution, and transfer of chemotherapy into syringes or IV bags to help contain hazardous drug aerosols and vapors. Administration occurs in clinical care areas, where CSTDs may be used during connection and delivery of the medication to the patient, when the dosage form and device compatibility allow. Together, these applications help support safer handling practices across both pharmacy compounding and bedside chemotherapy administration.
                      What Is the Difference Between Using a CSTD in Preparation vs Administration?

                      What are the typical steps for using a CSTD (general workflow)?

                      Steps vary by system, setting, and treatment protocol, but commonly include vial access, syringe preparation, transfer to an IV bag or administration set, and safe disconnection. The aim is to reduce occupational exposure to hazardous drugs by reducing leaks, aerosol/vapor escape, and surface contamination.

                      Can CSTDs be used for all hazardous drugs?

                      Yes. CSTDs like Chemfort® are designed for a wide range of hazardous drugs, including chemotherapy agents and biologics. The plastics that comprise the Chemfort® CSTD provide effective chemical and mechanical resistance to all drug ingredients. Compatibility should be verified for each use case.
                      Can CSTDs be used for all hazardous drugs?